Drugs / Avelumab
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cutaneous neuroendocrine carcinoma 2 milestones | |||||
| Filed | US (FDA) | — | cutaneous neuroendocrine carcinoma | 2016-11-29 | “the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab.” pfizer.com ↗ |
| Filed | EU (EMA) | BAVENCIO | cutaneous neuroendocrine carcinoma | 2016-10-30 | “the European Medicines Agency (EMA) has validated for review Merck KGaA, Darmstadt, Germany's Marketing Authorization Application (MAA) for avelumab” pfizer.com ↗ “the European Medicines Agency (EMA) has validated for review Merck KGaA, Darmstadt, Germany's Marketing Authorization Application for avelumab” pfizer.com ↗ |
| Filed renal cell adenocarcinoma 3 milestones | |||||
| Filed | EU (EMA) | BAVENCIO | renal cell adenocarcinoma | 2019-03-08 | “European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO ® (avelumab) in combination with INLYTA® (axitinib)*” pfizer.com ↗ “The European Medicines Agency (EMA) validated the Type II variation application for BAVENCIO in combination with INLYTA in advanced RCC in March 2019” pfizer.com ↗ |
| Filed | US (FDA) | BAVENCIO | renal cell adenocarcinoma | 2019-02-11 | “the US Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO” pfizer.com ↗ “FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO” pfizer.com ↗ |
| Filed | Japan (PMDA) | BAVENCIO | renal cell adenocarcinoma | 2019-01-30 | “A supplemental application for BAVENCIO in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019.” pfizer.com ↗ “A supplemental application for BAVENCIO in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019.” pfizer.com ↗ “a supplemental application for BAVENCIO in combination with INLYTA in unresectable or metastatic RCC was submitted in Japan in January 2019” pfizer.com ↗ “A supplemental application for BAVENCIO+INLYTA in unresectable or metastatic RCC was submitted in Japan on January 30, 2019.” pfizer.com ↗ “A supplemental application for BAVENCIO+INLYTA in unresectable or metastatic RCC was submitted in Japan on January 30, 2019.” prnewswire.com ↗ “A supplemental application for the combination in unresectable or metastatic RCC has also been submitted in Japan.” pfizer.com ↗ |
| Filed urothelial carcinoma 3 milestones | |||||
| Filed | EU (EMA) | BAVENCIO | urothelial carcinoma | 2020-06-22 | “the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO® (avelumab)” pfizer.com ↗ |
| Filed | US (FDA) | BAVENCIO | urothelial carcinoma | 2020-04-08 | “announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for Bavencio” pfizer.com ↗ |
| Filed | US (FDA) | — | urothelial carcinoma | 2017-02-28 | “the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab* as a treatment for patients with...” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | BAVENCIO | — | 2018-10-19 – 2024-10-11 | fda.gov ↗ |
| Approved | EU (EMA) | Bavencio | — | 2017-09-18 | europa.eu ↗ |
| Approved | US (FDA) | BAVENCIO | — | 2017-03-23 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials | ||||||
| Phase 0 | NCT06204614 | Jun 2024 → Jul 2028 expected | infiltrating bladder urothelial carcinoma | Brigham and Women's Hospital | Enrolling by invitation | No outcome recorded |
| Phase 0 | NCT04065555 | Oct 2020 → Jun 2022 | head and neck cancer | Presage Biosciences | Completed | No outcome recorded |
| Phase 0 | NCT03481920 | Jan 2018 → Jan 2019 | pancreatic ductal adenocarcinoma | PH Research, S.L. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT03244176 | Jul 2017 → Jun 2022 overdue | large B-cell lymphoma | Austin Health | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03158883 | May 2017 → Apr 2020 | non-small cell lung carcinoma | Megan Daly, MD | Completed | No outcome recorded |
| Phase 145 trials · 2 met primary · 2 missed | ||||||
| Phase 1 | NCT05222932 | Mar 2023 → Dec 2026 expected | head and neck squamous cell carcinoma, melanoma | TILT Biotherapeutics Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05396833 | Jun 2022 → Jul 2026 | cancer of unknown primary site | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05395052 | May 2022 → Aug 2023 | breast cancer, colorectal cancer, gastroesophageal cancer, head and neck cancer +3 | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT05081180 | Dec 2021 → Feb 2026 overdue | central nervous system neoplasm | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05069935 | Oct 2021 → Aug 2023 | cancer | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT04601402 | Oct 2020 → Jan 2023 | head and neck squamous cell carcinoma, non-small cell lung carcinoma, urothelial carcinoma | Genome & Company | Completed | Met primary |
| Phase 1 | NCT04360941 | Aug 2020 → Jul 2027 expected | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, female breast carcinoma, triple-negative breast carcinoma | Royal Marsden NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 1 | NCT04004442 | Feb 2020 → Apr 2022 overdue | urothelial carcinoma | University of Oklahoma | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04242238 | Jan 2020 → Aug 2025 | dedifferentiated liposarcoma, leiomyosarcoma, myxofibrosarcoma, undifferentiated pleomorphic sarcoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03915405 | Sep 2019 → Nov 2022 | urothelial carcinoma | Kyowa Kirin, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03941262 | Jul 2019 → Feb 2023 | carcinoma, metastatic malignant neoplasm | NKGen Biotech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03719768 | Jun 2019 → Jul 2022 | malignant tumor of meninges, neoplastic meningitis | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03905135 | Jun 2019 → Mar 2021 | Sezary syndrome, anaplastic large cell lymphoma, mycosis fungoides, peripheral T-cell lymphoma, not otherwise specified | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT03861403 | May 2019 → Jul 2020 | castration-resistant prostate carcinoma, hormone receptor-positive breast cancer, triple-negative breast carcinoma | Leap Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT03845166 | Mar 2019 → Aug 2026 overdue | castration-resistant prostate carcinoma, colorectal cancer, hormone receptor-positive breast cancer, renal cell carcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03704467 | Mar → Nov 2019 | ovarian cancer | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03724890 | Nov 2018 → Sep 2021 | cancer | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03636503 | Oct 2018 → Jul 2021 | follicular lymphoma | Dana-Farber Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03575013 | Oct 2018 → Dec 2021 | urothelial carcinoma | Yousef Zakharia | Completed | No outcome recorded |
| Phase 1 | NCT03893903 | Oct 2018 → Sep 2024 | malignant glioma | German Cancer Research Center | Completed | No outcome recorded |
| Phase 1 | NCT03514719 | Oct 2018 → Sep 2021 | non-small cell lung carcinoma | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03200587 | Jun 2018 → Apr 2020 | renal cell carcinoma | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT03341806 | Jun 2018 → Oct 2021 | glioblastoma | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 1 | NCT03502681 | Jun 2018 → Oct 2019 | urothelial carcinoma | Monika Joshi, MD | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03440567 | Jun 2018 → Jun 2024 | diffuse large B-cell lymphoma, mantle cell lymphoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03498378 | Jun 2018 → Feb 2020 overdue | head and neck squamous cell carcinoma | Kathryn Gold | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03558139 | May 2018 → Dec 2020 | ovarian cancer | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT03523390 | Apr 2018 → Jul 2019 | metastatic neoplasm | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT03483883 | Mar 2018 → Jul 2020 | sarcomatoid renal cell carcinoma | Abramson Cancer Center at Penn Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03451825 | Mar 2018 → Jul 2021 | lymphoma, refractory malignant neoplasm | EMD Serono Research & Development Institute, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT03395873 | Jan 2018 → May 2019 | acute myeloid leukemia | Milton S. Hershey Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT03267836 | Jan 2018 → Apr 2023 | meningioma | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03270176 | Oct 2017 → Mar 2022 | non-small cell lung carcinoma | Debiopharm International SA | Completed | Missed primary |
| Phase 1 | NCT03289533 | Sep 2017 → Aug 2019 | hepatocellular carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03252938 | Aug 2017 → Sep 2026 overdue | lung adenocarcinoma, peritoneal carcinomatosis, urothelial carcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02923466 | Apr 2017 → Feb 2022 | cancer | Vyriad, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02938273 | Feb 2017 → Jun 2019 | head and neck squamous cell carcinoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02994953 | Jan 2017 → Oct 2020 | cancer | EMD Serono Research & Development Institute, Inc. | Terminated | Missed primary |
| Phase 1 | NCT03056599 | Dec 2016 → Jul 2021 | soft tissue sarcoma | Presage Biosciences | Completed | Met primary |
| Phase 1 | NCT02943317 | Oct 2016 → Aug 2018 | malignant epithelial tumor of ovary | Verastem, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT02603419 | Mar 2016 → Dec 2018 | Hodgkins lymphoma | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02493751 | Oct 2015 → Apr 2018 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02222922 | Oct 2014 → Nov 2019 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01943461 | Sep 2013 → Jan 2015 | cancer | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT01772004 | Jan 2013 → Dec 2019 | cancer | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 1/257 trials · 2 missed | ||||||
| Phase 1/2 | NCT05687721 | Jun 2025 | urothelial carcinoma | VA Office of Research and Development | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05102721 | Dec 2022 → Dec 2028 expected | pancreatic adenocarcinoma | Vaccinex Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05267626 | Apr 2022 → Feb 2027 expected | cutaneous melanoma, metastatic malignant neoplasm, non-small cell lung carcinoma | Aulos Bioscience, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04902040 | Apr 2021 → Feb 2025 | cutaneous melanoma, cutaneous neuroendocrine carcinoma, non-small cell lung carcinoma, renal cell adenocarcinoma +1 | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT04071236 | Oct 2020 → Apr 2027 expected | castration-resistant prostate carcinoma, metastatic carcinoma in the bone, metastatic malignant neoplasm in the lymph nodes | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04261855 | Oct 2020 → Dec 2026 expected | cutaneous neuroendocrine carcinoma | Melanoma and Skin Cancer Trials Limited | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04068194 | Apr 2020 → Jul 2027 expected | cholangiocarcinoma, gallbladder carcinoma, metastatic malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04266912 | Mar 2020 → Nov 2024 overdue | metastatic malignant neoplasm, refractory malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04396223 | Feb 2020 → Apr 2025 overdue | gestational trophoblastic neoplasm | Hospices Civils de Lyon | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04052204 | Dec 2019 → Sep 2020 | castration-resistant prostate carcinoma, head and neck squamous cell carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT03892642 | May 2019 → Mar 2021 | urinary bladder cancer | University of Oklahoma | Completed | No outcome recorded |
| Phase 1/2 | NCT03964532 | Apr 2019 → Apr 2027 expected | breast cancer | Georgetown University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03787602 | Mar 2019 → Nov 2024 | cutaneous neuroendocrine carcinoma | Kartos Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT03844763 | Jan 2019 → Jun 2024 | head and neck cancer | Gruppo Oncologico del Nord-Ovest | Unknown | No outcome recorded |
| Phase 1/2 | NCT03498196 | Dec 2018 → Dec 2019 | urinary bladder carcinoma | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03750071 | Nov 2018 → Dec 2021 | glioblastoma | Vaximm GmbH | Unknown | No outcome recorded |
| Phase 1/2 | NCT03699384 | Oct 2018 → Feb 2019 | acute myeloid leukemia | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03563157 | Sep 2018 → Apr 2019 | colorectal cancer | ImmunityBio, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03647423 | Aug 2018 → Aug 2020 | chordoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03637491 | Aug 2018 → Dec 2020 | pancreatic ductal adenocarcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT03169777 | Aug 2018 → Jan 2019 | colorectal cancer | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03586869 | Jul 2018 → Apr 2019 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03490292 | May 2018 → Jan 2022 | esophageal cancer, gastroesophageal cancer | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1/2 | NCT03563170 | May 2018 → Aug 2019 | hepatocellular carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03475953 | May 2018 → Dec 2024 | biliary tract cancer, colorectal cancer, digestive system neuroendocrine neoplasm, gastroesophageal cancer +9 | Institut Bergonié | Unknown | No outcome recorded |
| Phase 1/2 | NCT03409458 | Apr 2018 → Jun 2022 | non-small cell lung carcinoma | Promontory Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03152565 | Mar 2018 → Jun 2019 | colorectal carcinoma | Grupo Espanol Multidisciplinario del Cancer Digestivo | Completed | Missed primary |
| Phase 1/2 | NCT03169738 | Feb 2018 → Jan 2019 | non-small cell lung carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03387111 | Jan 2018 → Apr 2019 | squamous cell carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03387098 | Dec 2017 → Sep 2018 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03390296 | Dec 2017 → Feb 2022 | acute myeloid leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03317496 | Dec 2017 → Jun 2021 | non-small cell lung carcinoma, urothelial carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT03399552 | Dec 2017 → Jan 2023 | malignant mesothelioma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03175666 | Dec 2017 → Jan 2019 | triple-negative breast carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03167164 | Dec 2017 → Jan 2019 | cutaneous neuroendocrine carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169790 | Dec 2017 → Jan 2019 | non-Hodgkin lymphoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03197571 | Dec 2017 → Jan 2019 | urothelial carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03197584 | Dec 2017 → Feb 2019 | ovarian carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169764 | Dec 2017 → Jan 2019 | head and neck squamous cell carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03386929 | Nov 2017 → Dec 2022 | non-small cell lung carcinoma | Worldwide Innovative Network Association | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03278405 | Nov 2017 → Aug 2019 | neuroendocrine carcinoma | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 1/2 | NCT03329248 | Nov 2017 → Aug 2018 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03050554 | Oct 2017 → Oct 2019 | non-small cell lung carcinoma | Andrew Sharabi | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03330405 | Oct 2017 → Feb 2022 | — | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT03268057 | Oct 2017 → Sep 2020 | non-small cell lung carcinoma | Vaccinex Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03074318 | Sep 2017 → Nov 2020 | leiomyosarcoma, liposarcoma | Fred Hutchinson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03260023 | Sep 2017 → Sep 2024 overdue | anal squamous cell carcinoma, cervical carcinoma, squamous cell carcinoma of penis, vulvar squamous cell carcinoma | Transgene | Active not recruiting | Missed primary |
| Phase 1/2 | NCT03136406 | Aug → Nov 2017 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03217747 | Aug 2017 → Sep 2025 overdue | castration-resistant prostate carcinoma, metastatic carcinoma in the bone, metastatic prostate carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02953561 | Feb 2017 → Sep 2019 | acute myeloid leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02813135 | Aug 2016 → Feb 2031 expected | childhood malignant neoplasm | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02767063 | Jul 2016 → Dec 2027 expected | chronic myeloid leukemia | Versailles Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02584634 | Dec 2015 → Feb 2021 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT02554812 | Nov 2015 → Mar 2023 | cancer of unknown primary site | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT02584829 | Nov 2015 → Dec 2018 | — | Fred Hutchinson Cancer Center | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02630368 | Sep 2015 → May 2023 | breast cancer, soft tissue sarcoma | Institut Bergonié | Unknown | No outcome recorded |
| Phase 1/2 | NCT02349633 | May 2015 → May 2020 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 2123 trials · 7 met primary · 6 missed | ||||||
| Phase 2 | NCT06557278 | Nov 2026 → Jun 2028 | colorectal cancer | Mirror Biologics, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT07460245 | Jun 2026 overdue | urothelial carcinoma | Italian Oncology Group for Clinical Research | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07110038 | Dec 2025 → May 2029 expected | squamous cell carcinoma of penis | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT07224971 | Dec 2025 → May 2027 expected | non-small cell lung carcinoma | Liza Villaruz, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT07225374 | Sep 2025 → Jul 2026 overdue | renal pelvis/ureter urothelial carcinoma | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06686381 | Apr 2025 → Aug 2028 expected | urinary bladder cancer | American University of Beirut Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06869473 | Feb 2025 → Aug 2027 expected | head and neck squamous cell carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT06640725 | Jan 2025 → Oct 2027 expected | head and neck squamous cell carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Recruiting | No outcome recorded |
| Phase 2 | NCT06518564 | Nov 2024 → Aug 2027 expected | endometrial carcinoma | Panagiotis Konstantinopoulos, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT06424717 | Aug 2024 → Jan 2026 | urothelial carcinoma | EMD Serono Research & Development Institute, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Show all 123 trials opens the full record — a long page | ||||||
| Phase 318 trials · 1 met primary · 4 missed | ||||||
| Phase 3 | NCT05092958 | Jun 2022 → Jul 2029 expected | renal pelvis urothelial carcinoma, ureter cancer, urethra transitional cell carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04637594 | May 2022 → Jun 2024 overdue | renal pelvis urothelial carcinoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05059522 | Sep 2021 → Dec 2026 expected | non-small cell lung carcinoma, ovarian cancer, urothelial carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03815643 | Mar 2019 → Nov 2026 expected | cancer | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03827044 | Aug 2018 → Jan 2021 | POLE-related polyposis and colorectal cancer syndrome, malignant colon neoplasm | Royal Marsden NHS Foundation Trust | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03642132 | Jul 2018 → Dec 2021 | ovarian cancer | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03271372 | Dec 2017 → Jan 2029 expected | — | University of Washington | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02999087 | Sep 2017 → Dec 2027 expected | head and neck squamous cell carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02951156 | Dec 2016 → Dec 2019 | diffuse large B-cell lymphoma | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02952586 | Nov 2016 → Dec 2019 | head and neck squamous cell carcinoma | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT02926196 | Jun 2016 → Jun 2024 | triple-negative breast carcinoma | Veneto Institute of Oncology IRCCS | Completed | No outcome recorded |
| Phase 3 | NCT02718417 | May 2016 → Sep 2018 | ovarian carcinoma | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT02603432 | Apr 2016 → Oct 2019 | urothelial carcinoma | Pfizer | Completed | Met primary |
| Phase 3 | NCT02684006 | Mar 2016 → Aug 2023 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02625610 | Dec 2015 → Sep 2019 | gastroesophageal adenocarcinoma | EMD Serono Research & Development Institute, Inc. | Completed | Missed primary |
| Phase 3 | NCT02580058 | Dec 2015 → Sep 2018 | ovarian cancer | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02576574 | Oct 2015 → Dec 2021 | non-small cell lung carcinoma | EMD Serono Research & Development Institute, Inc. | Completed | Mixed |
| Phase 3 | NCT02395172 | Mar 2015 → Nov 2017 | non-small cell lung carcinoma | EMD Serono Research & Development Institute, Inc. | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT03826589 | Jun 2019 → Mar 2024 | cervical cancer | The University of Hong Kong | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03089658 | — | cutaneous neuroendocrine carcinoma | Merck KGaA, Darmstadt, Germany | Approved for marketing | No outcome recorded |
| Comparator or background therapy20 trials | ||||||
| Phase 0 | NCT05358938 Background | Jun 2022 → Oct 2024 overdue | cutaneous melanoma, cutaneous neuroendocrine carcinoma, skin squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06302426 Background | Jul 2024 → Oct 2026 expected | neoplasm | Inimmune Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT04551885 Background | Sep 2020 → Aug 2023 | cancer | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT04387084 Background | Aug 2020 → Mar 2027 expected | skin cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04328844 Background | Feb 2020 → Dec 2023 overdue | myelofibrosis, non-Hodgkin lymphoma, non-small cell lung carcinoma, uveal melanoma | iOnctura | Active not recruiting | Met primary |
| Phase 1 | NCT02890368 Background | Sep 2016 → Mar 2020 | breast carcinoma, cutaneous neuroendocrine carcinoma, melanoma, mycosis fungoides +2 | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT06939036 Background | Jul → Dec 2025 | cutaneous neuroendocrine carcinoma, small cell lung carcinoma | Ariceum Therapeutics GmbH | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04954599 Background | May 2023 → Feb 2027 expected | cancer of unknown primary site | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04260802 Background | Sep 2020 → Nov 2025 | cervical cancer, cutaneous neuroendocrine carcinoma, gastric cancer, head and neck squamous cell carcinoma +9 | Ocellaris Pharma, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03747484 Background | Jul 2019 → Jan 2024 | — | Fred Hutchinson Cancer Center | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03387085 Background | Mar 2018 → Sep 2020 | triple-negative breast carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03167177 Background | Dec 2017 → Jan 2019 | melanoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02915523 Comparator | Dec 2016 → Feb 2019 | fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer | Syndax Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT06225596 Comparator | Jan 2024 → Mar 2028 expected | urothelial carcinoma | BicycleTx Limited | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04887831 Background | Jun 2021 → Apr 2023 | bone marrow failure syndrome, neutropenia, urinary bladder cancer, urothelial carcinoma | G1 Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04571632 Comparator | Sep 2020 → Dec 2023 | non-small cell lung carcinoma | University Hospital Brussels | Unknown | Missed primary |
| Phase 2 | NCT03573648 Comparator | Nov 2018 → Dec 2026 expected | breast cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04510597 Comparator | Mar 2021 → Jul 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT02625623 Comparator | Dec 2015 → Sep 2017 | gastric cancer, gastroesophageal adenocarcinoma | EMD Serono Research & Development Institute, Inc. | Completed | Missed primary |
| Phase 4 | NCT06820255 Comparator | Jan 2025 → Jan 2026 overdue | bladder transitional cell carcinoma, renal pelvis/ureter urothelial carcinoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 103
| Date | Issuer | Release |
|---|---|---|
| 2025-11-07 | Aulos Bioscience, Inc. | Results New Phase 2 Data for Aulos Bioscience’s Imneskibart Reveal Clinical Activity in Melanoma and Non-Small Cell Lung Cancer aulosbio.com ↗
Two patients with NSCLC that progressed on prior anti-PD-1 therapy-based regimens received imneskibart (9 mg/kg) Q2W and one loading dose of low-dose, subcutaneous aldesleukin in combination with avelumab (800 mg) Q2W. |
| 2025-05-22 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Showcases Innovation in Advanced Cancers and Rare Tumors at ASCO 2025 emdserono.com ↗
When used in the maintenance setting, the combination therapy significantly improved progression-free survival (PFS) versus BAVENCIO alone (HR 0.49 [95% CI, 0.31-0.76]); median PFS was 11.17 months versus 3.75 months, respectively. |
| 2025-05-22 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, Showcases Innovation in Advanced Cancers and Rare Tumors at ASCO 2025 emdgroup.com ↗
When used in the maintenance setting, the combination therapy significantly improved progression-free survival (PFS) versus BAVENCIO alone (HR 0.49 [95% CI, 0.31-0.76]); median PFS was 11.17 months versus 3.75 months, respectively. |
| 2025-04-24 | Transgene | Results Transgene Provides Business and Financial Update for Q1 2025 transgene.com ↗
While the primary endpoint of the Phase II study was not met, positive signals in the cervical cancer subgroup have been observed and further details will be included in the poster presentation. |
| 2024-10-14 | Transgene | Results Transgene Provides Update on Phase II Trial of Therapeutic Cancer Vaccine TG4001 in Recurrent or Metastatic HPV16-Positive Cervical and Anogenital Cancers transgene.com ↗
The pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. |
| 2024-09-19 | Oncolytics Biotech | Results Oncolytics Biotech® Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study oncolyticsbiotech.com ↗
Final BRACELET-1 efficacy data were collected and analyzed two years after the last patient was enrolled as specified by the protocol. |
| 2024-05-24 | Oncolytics Biotech | Results Oncolytics Biotech® ASCO Abstracts Highlight Pelareorep’s Potential in Pancreatic Cancer and Immunotherapeutic Mechanism of Action oncolyticsbiotech.com ↗
The addition of the PD-L1 inhibitor avelumab, unlike atezolizumab, eliminated pre-existing TIL expansion in the blood and reduced pelareorep’s clinical activity. |
| 2024-05-23 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono to Showcase Advances in the Science of Cancer With New Data Presented at ASCO 2024 emdserono.com ↗
These findings further support the use of the JAVELIN Bladder regimen as a standard of care in this setting and as an important first-line treatment regimen for patients with low tumor burden in particular, where pronounced efficacy with BAVENCIO (vs BSC alone) was observed. |
| 2024-01-22 | EMD Serono Research & Development Institute, Inc. | Results Multiple New Analyses Reinforce the Role of BAVENCIO® (avelumab) First-Line Maintenance as a Standard of Care in Patients with Locally Advanced or Metastatic Urothelial Carcinoma emdserono.com ↗
Data include real-world studies that confirm median overall survival (OS) of approximately 30 months in patients without progression after first-line chemotherapy. |
| 2024-01-22 | Merck KGaA, Darmstadt, Germany | Results Multiple New Analyses Reinforce the Role of BAVENCIO® (avelumab) as a Standard of Care emdgroup.com ↗
In an exploratory analysis, median OS from the start of platinum-based chemotherapy was 26.5 months (95% CI, 23.4 to 30.1). |
| 2023-06-05 | Oncolytics Biotech | Results Oncolytics Biotech® Announces Updated Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial that Show Pelareorep Driving Robust Increases in Progression-Free Survival and Confirmed Overall Response Rate oncolyticsbiotech.com ↗ |
| 2023-05-25 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Highlights Commitment to Improving Cancer Outcomes at ASCO 2023 emdserono.com ↗
Poster discussions, including long-term safety analyses and an analysis of quality-adjusted survival from the Phase III JAVELIN Bladder 100 study, confirm the acceptable long-term benefit-risk profile as well as the net benefit estimate of BAVENCIO first-line (1L) maintenance and further support its use as a standard of care for advanced UC. |
| 2023-04-30 | Immutep S.A.S. | Regulatory Immutep Receives Approval to Initiate INSIGHT-005 Trial Evaluating Eftilagimod Alpha and Anti-PD-L1 Therapy BAVENCIO® immutep.com ↗ |
| 2023-02-13 | EMD Serono Research & Development Institute, Inc. | Results New Analyses Reinforce Survival Benefit of BAVENCIO First-Line Maintenance Treatment in Patients With Advanced Urothelial Carcinoma emdserono.com ↗
Long-term follow-up of the Phase III JAVELIN Bladder 100 study demonstrated median overall survival from start of chemotherapy of 29.7 months among patients receiving BAVENCIO, establishing a new reference point for treatment outcomes in clinical studies |
| 2022-12-08 | Promontory Therapeutics Inc. | Results Promontory Therapeutics Presents Safety and Efficacy Data of PT-112 in Combination with PD-L1 Inhibition in Treatment of Advanced Non-Small Cell Lung Cancer at ESMO I-O 2022 promontorytx.com ↗
The poster titled, "A phase 2a study of the novel immunogenic cell death (ICD) inducer PT-112 plus avelumab in advanced non-small cell lung cancer patients," demonstrated that the PT-112 and avelumab combination is well-tolerated with manageable safety profile, and showed meaningful clinical benefits in patients without known predictive markers for immunotherapy response. |
| 2022-11-02 | Transgene | Results Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers transgene.com ↗
Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers |
| 2022-09-27 | Transgene | Results R&D Day: Presentations to Highlight Transgene’s Competitive Positioning, Capabilities to Engineer Novel Immunotherapies for Patients with Cancer, and Update on Initial Clinical Data transgene.com ↗
We will provide updated data on the previous Phase Ib/II trial of TG4001 and avelumab in HPV16-positive cancer patients |
| 2022-05-26 | NKGen Biotech, Inc. | Results NKGen Biotech To Present SNK01 Clinical Data at the 2022 ASCO Annual Meeting nkgenbiotech.com ↗
SNK01 combined with avelumab showed efficacy in 17 advanced stage cancer patients (all heavily pre-treated with a median of 5 lines of prior therapy) |
| 2022-02-18 | EMD Serono Research & Development Institute, Inc. | Results Long-Term Follow-Up Data Reinforce Continued Overall Survival Benefit of BAVENCIO® (avelumab) First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma emdserono.com ↗ |
| 2021-06-04 | Immutep S.A.S. | Results Immutep Reports Positive Final Data from the INSIGHT-004 Phase I Study of LAG-3 Therapy, Efti, at ASCO 2021 immutep.com ↗
Encouraging activity signals from the combination of efti and avelumab with a response rate of 41.7% in different solid tumours (DCR 50%) acc. to RECIST 1.1 |
| 2021-05-20 | Promontory Therapeutics Inc. | Results Phosplatin Therapeutics Reports Phase 1b Study Results of Immunogenic Cell Death Inducer PT-112 Plus PD-L1 Inhibitor avelumab in Metastatic Prostate Cancer at ASCO Annual Meeting promontorytx.com ↗
The combination was generally well tolerated and demonstrated meaningful anti-tumor effects. |
| 2021-05-18 | EMD Serono Research & Development Institute, Inc. | Results Data from EMD Serono’s Oncology Portfolio Highlight Significant Advances in Cancer Care at ASCO21 emdserono.com ↗
New analyses from pivotal BAVENCIO® study reinforce unique clinical benefits across different subgroups in the treatment of advanced urothelial carcinoma |
| 2021-01-25 | Pfizer | Regulatory European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2021-01-24 | EMD Serono Research & Development Institute, Inc. | Regulatory European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma emdserono.com ↗
EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved BAVENCIO® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. |
| 2020-12-11 | Pfizer | Regulatory BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗
The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021. |
| 2020-12-11 | Pfizer | Regulatory BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗
The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021. |
| 2020-12-10 | EMD Serono Research & Development Institute, Inc. | Regulatory BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma emdserono.com ↗ |
| 2020-11-09 | Transgene | Results Transgene presents e-poster outlining detailed results from the Phase 1b/2 trial of TG4001 in combination with avelumab in advanced HPV-positive cancers at SITC 2020 transgene.com ↗
Transgene presents e-poster outlining detailed results from the Phase 1b/2 trial of TG4001 in combination with avelumab in advanced HPV-positive cancers at SITC 2020 |
| 2020-11-05 | Transgene | Results Transgene reports business update and end Q3 2020 financial position transgene.com ↗
The combination of TG4001 and avelumab demonstrated anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers. |
| 2020-10-27 | Transgene | Results Transgene announces detailed results from clinical study of TG4001 in combination with avelumab in advanced HPV-positive cancers transgene.com ↗
The combination of TG4001 and avelumab demonstrates anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers. |
| 2020-10-19 | Transgene | Results Acceptance of Late Breaking Abstract at Upcoming SITC 2020 Conference, on the detailed results from clinical study of TG4001 in combination with avelumab in advanced HPV-positive cancers transgene.com ↗
As a reminder, the analysis of the trial data demonstrate d clinical activity of the combination regimen and confirmed a manageable safety profile. |
| 2020-09-18 | Pfizer | Results BAVENCIO Pivotal Phase III JAVELIN Bladder 100 Results Published in The New England Journal of Medicine pfizer.com ↗
The clinical benefits of BAVENCIO were seen across a range of patient populations. |
| 2020-09-18 | Promontory Therapeutics Inc. | Results Phosplatin Therapeutics Announces Results from Phase 1b Dose Escalation Study of PT-112 Plus Avelumab in Patients with Solid Tumors promontorytx.com ↗
The combination of PT-112 and avelumab was found to be safe and well tolerated in 36 heavily pre-treated solid tumor patients who have exhausted standard therapy options, the majority of whom had received prior immunotherapy. |
| 2020-09-17 | EMD Serono Research & Development Institute, Inc. | Results BAVENCIO-Pivotal-Phase-III-JAVELIN-Bladder-100-Results-Published-in-The-New-England-Journal-of-Medicine emdserono.com ↗
The clinical benefits of BAVENCIO were seen across a range of patient populations.1 |
| 2020-09-16 | Transgene | Results Positive clinical results for TG4001 and TG6002 and financial visibility secured until 2022 transgene.com ↗
The analysis of the efficacy data from the Phase 1b/2 trial combining TG4001 with avelumab in HPV16-positive recurrent and/or metastatic malignancies showed a promising clinical activity in the overall study population (34 evaluable patients). |
| 2020-09-16 | Immutep S.A.S. | Results Immutep Reports Improving Results from INSIGHT-004 Trial immutep.com ↗
41.7% of patients showed a Partial Response to the combination therapy of eftilagimod alpha and avelumab (previously 33%) |
| 2020-09-14 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono Advances Oncology Portfolio and Pipeline with New and Long-term Data in Multiple Cancers at ESMO 2020 emdserono.com ↗
New analyses from Phase III JAVELIN Bladder 100 study of BAVENCIO®* assess efficacy across subgroups, patient-reported outcomes and exploratory biomarkers in advanced urothelial cancer |
| 2020-08-31 | NKGen Biotech, Inc. | Regulatory NKMax America Receives FDA Clearance to Amend its Current Phase I Monotherapy Trial to Include an Additional New Cohort of SNK01 + Checkpoint Inhibitor in Refractory Solid Tumors. nkgenbiotech.com ↗ |
| 2020-07-22 | Transgene | Results Transgene Reports Results from Clinical Study of TG4001 in Combination with Avelumab in Advanced HPV-Positive Cancers transgene.com ↗
This analysis confirms that TG4001 can be safely combined with an immune checkpoint inhibitor and shows clinical activity of this combination regimen . |
| 2020-06-30 | Pfizer | Regulatory FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2020-06-29 | EMD Serono Research & Development Institute, Inc. | Regulatory FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma emdserono.com ↗
today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. |
| 2020-06-22 | Pfizer | Regulatory European Medicines Agency Validates Application for BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗
Merck and Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO® (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). |
| 2020-06-22 | Pfizer | Regulatory European Medicines Agency Validates Application for BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO® (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). |
| 2020-05-30 | Immutep S.A.S. | Results Immutep Reports First Results from INSIGHT-004 Study immutep.com ↗
Overall, 33% of patients showed a Partial Response to the combination therapy of eftilagimod alpha and avelumab, with three patients not yet evaluable |
| 2020-04-30 | EMD Serono Research & Development Institute, Inc. | Results Data From EMD Serono at ASCO 2020 to Showcase Significant Clinical Advances in Cancer Care emdserono.com ↗
The first presentation of detailed results from the Phase III JAVELIN Bladder 100 study (Abstract #LBA1), which show an overall survival benefit for BAVENCIO® (avelumab) versus best supportive care in the first-line maintenance treatment of advanced urothelial carcinoma (UC)*, |
| 2020-04-20 | Genome & Company | Regulatory [보도자료] 지놈앤컴퍼니, 첫 항암 마이크로바이옴 GEN-001 美 임상계획 승인 genomecom.co.kr ↗
지놈앤컴퍼니는 오늘 미국 식품의약국 (FDA) 으로부터 자사 개발 항암 마이크로바이옴 GEN-001 과 바벤시오 ®( 성분명 : 아벨루맙 ) 의 병용요법 1/1b 상 임상시험계획 (IND) 이 승인되었다고 밝혔다 . |
| 2020-04-08 | EMD Serono Research & Development Institute, Inc. | Regulatory EMD Serono and Pfizer Receive US FDA Breakthrough Therapy Designation and Submit Application for BAVENCIO® for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma emdserono.com ↗
The FDA granted Breakthrough Therapy Designation to BAVENCIO for this indication, and the sBLA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. |
| 2020-04-08 | 4SC AG | Regulatory FDA Accepts IND Application for MERKLIN 2 Study 4sc.com ↗
4SC AG (4SC, FSE Prime Standard: VSC) today announced that its Investigational New Drug (IND) application for domatinostat in combination with avelumab (Bavencio®) has been accepted by the U.S. Food and Drug Administration (FDA). |
| 2020-03-13 | Pfizer | Results EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study pfizer.com ↗
The alliance has accepted the recommendation of the independent Data Monitoring Committee (DMC) to terminate the JAVELIN Head and Neck 100 trial, as the study is unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS) based on a preplanned interim analysis. |
| 2020-03-12 | EMD Serono Research & Development Institute, Inc. | Results EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study emdserono.com ↗
The alliance has accepted the recommendation of the independent Data Monitoring Committee (DMC) to terminate the JAVELIN Head and Neck 100 trial, as the study is unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS) based on a preplanned interim analysis. |
| 2020-02-11 | Promontory Therapeutics Inc. | Results Phosplatin Therapeutics presents positive data from two phase I studies in metastatic castrate-resistant prostate cancer patients at the Genitourinary Cancers Symposium promontorytx.com ↗
Safety and biological activity demonstrated in heavily pre-treated mCRPC sub-population with PT-112 monotherapy and in combination therapy with anti-PD-L1 immune checkpoint inhibitor avelumab. |
| 2020-01-06 | Pfizer | Results BAVENCIO Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗
A statistically significant improvement in OS was demonstrated in the BAVENCIO arm in each of the co-primary populations: all randomized patients and patients with PD-L1–positive tumors. |
| 2020-01-05 | EMD Serono Research & Development Institute, Inc. | Results BAVENCIO Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma emdserono.com ↗
At the planned interim analysis, Phase III JAVELIN Bladder 100 study met the primary endpoint of prolonging overall survival (OS) as a first-line maintenance treatment versus standard of care |
| 2019-12-18 | Immutep S.A.S. | Results INSIGHT-004 Clinical Trial Update immutep.com ↗
Out of 6 patients, 1 patient experienced a partial response according to RECIST 1.1. |
| 2019-12-13 | 4SC AG | Results 4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer 4sc.com ↗
Safety Review Committee examined data from the second dose cohort and recommends EMERGE to continue with the third and final dose cohort |
| 2019-12-11 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics to Expand Study of BXCL701 into Multiple Advanced Solid Tumor Types bioxceltherapeutics.com ↗
The FDA has also accepted an IND application for the triple combination of BXCL701, bempegaldesleukin (produced by Nektar Therapeutics, Inc., or Nektar) and BAVENCIO ® (avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer. |
| 2019-11-08 | Pfizer | Results EMD Serono and Pfizer Provide Update on Phase III JAVELIN Gastric 100 Trial pfizer.com ↗
While the study showed clinical activity for avelumab in this setting, it did not meet the primary endpoints of superior overall survival compared with the standard of care |
| 2019-10-28 | Pfizer | Regulatory European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma pfizer.com ↗
today announced that the European Commission (EC) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). |
| 2019-09-30 | Transgene | Results Transgene Reports First Promising Efficacy Results with TG4001 in Combination with Avelumab in HPV-Positive Cancer at ESMO 2019 transgene.com ↗
3 of the 6 patients treated with the higher dose of TG4001 showed durable partial responses1. |
| 2019-09-27 | Pfizer | Results New Data for BAVENCIO® (avelumab) for Advanced Cancers to Be Presented at ESMO 2019 pfizer.com ↗
Analyses from the Phase III JAVELIN Renal 101 study support efficacy of BAVENCIO plus axitinib across multiple subgroups of patients with advanced renal cell carcinoma (RCC) |
| 2019-09-20 | Pfizer | Regulatory CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-07-25 | 4SC AG | Results 4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer 4sc.com ↗
Safety Review Committee examined data from the first dose cohort and recommends EMERGE to continue with a second dose cohort |
| 2019-06-03 | BioXcel Therapeutics Inc | Regulatory BioXcel Therapeutics Announces FDA Clearance of IND Application for Triple Combination in Pancreatic Cancer and CTA Acceptance for Double Combination in Aggressive Form of Prostate Cancer (tNEPC) for Lead Immuno-Oncology Program, BXCL701 bioxceltherapeutics.com ↗
FDA clearance of IND for BXCL701 triple combination therapy with Nektar’s bempegaldesleukin and BAVENCIO ® ( avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer |
| 2019-05-14 | Pfizer | Regulatory FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-04-30 | Immutep S.A.S. | Regulatory Operational Update immutep.com ↗
The trial protocol has now been approved by the competent authority and ethics committee and Immutep expects the first patient to be recruited in Q2 2019. |
| 2019-03-19 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, and Pfizer Announce Discontinuation of Phase III JAVELIN Ovarian PARP 100 Trial in Previously Untreated Advanced Ovarian Cancer prnewswire.com ↗
The decision to discontinue the JAVELIN Ovarian PARP 100 trial was not made for safety reasons. |
| 2019-03-19 | Pfizer | Results Merck KGaA, Darmstadt, Germany, and Pfizer Announce Discontinuation of Phase III JAVELIN Ovarian PARP 100 Trial in Previously Untreated Advanced Ovarian Cancer pfizer.com ↗
The alliance has notified health authorities and trial investigators of the decision to discontinue the trial. |
| 2019-03-08 | Pfizer | Regulatory European Medicines Agency Validates Application for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO ® (avelumab) in combination with INLYTA® (axitinib)* for the treatment of patients with advanced renal cell carcinoma (RCC). |
| 2019-03-07 | Syndax Pharmaceuticals | Results Syndax Pharmaceuticals Reports Fourth Quarter 2018 Financial Results and Provides Clinical and Business Update syndax.com ↗ |
| 2019-02-16 | Merck KGaA, Darmstadt, Germany | Results Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in the New England Journal of Medicine prnewswire.com ↗
Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). |
| 2019-02-16 | Pfizer | Results Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in The New England Journal of Medicine pfizer.com ↗
Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). |
| 2019-02-11 | Pfizer | Regulatory FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗
the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO ® (avelumab) in combination with INLYTA ® (axitinib)* for patients with advanced renal cell carcinoma (RCC). |
| 2018-12-21 | Pfizer | Results Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on JAVELIN Ovarian 100 Trial of Avelumab in Previously Untreated Advanced Ovarian Cancer pfizer.com ↗
Topline results showed that the study, which is evaluating avelumab in combination with and/or following platinum-based chemotherapy in previously untreated patients with ovarian cancer, would not achieve superiority in the pre-specified primary endpoint of progression-free survival. |
| 2018-11-19 | Pfizer | Results Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Avelumab in Platinum-Resistant/Refractory Ovarian Cancer pfizer.com ↗
did not meet the prespecified primary endpoints of overall survival (OS) or progression-free survival (PFS) |
| 2018-09-11 | Pfizer | Results BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Significantly Improved Progression-Free Survival in Previously Untreated Patients with Advanced Renal Cell Carcinoma in Phase III Study pfizer.com ↗ |
| 2018-06-05 | Merck KGaA, Darmstadt, Germany | Regulatory Brasil aprueba el uso de avelumab para tratar el carcinoma de células de Merkel, es la primera aprobación obtenida en América Latina prnewswire.com ↗ |
| 2018-06-04 | Merck KGaA, Darmstadt, Germany | Results Two-Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses with BAVENCIO® (avelumab) prnewswire.com ↗
At this two year follow-up update of the pivotal study, BAVENCIO continues to demonstrate clinically meaningful durable responses and stable rates of progression-free survival (PFS) and overall survival (OS) from previous analyses in patients who responded to this treatment. |
| 2018-06-04 | Pfizer | Results Two-Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses with BAVENCIO® (avelumab) pfizer.com ↗
At this two year follow-up update of the pivotal study, BAVENCIO continues to demonstrate clinically meaningful durable responses and stable rates of progression-free survival (PFS) and overall survival (OS) from previous analyses in patients who responded to this treatment. |
| 2018-05-17 | Merck KGaA, Darmstadt, Germany | Results Merck Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline prnewswire.com ↗
New data for avelumab* (BAVENCIO ® ), which is being jointly developed and commercialized with Pfizer, include an oral presentation on two-year results from the pivotal JAVELIN Merkel 200 trial. |
| 2018-05-16 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany Data at ASCO 2018 to Showcase Progress and Further Optionality of Oncology Pipeline prnewswire.com ↗
These long-term results include data on avelumab's duration of response and represent the first study to report long-term survival data for an immunotherapy in metastatic Merkel cell carcinoma (mMCC). |
| 2018-02-15 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer prnewswire.com ↗
The safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program; no new safety signals were identified. |
| 2017-12-21 | Merck KGaA, Darmstadt, Germany | Regulatory FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma prnewswire.com ↗ |
| 2017-12-21 | Pfizer | Regulatory FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2017-11-28 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Phase III JAVELIN Gastric 300 Study in Patients with Pre-Treated Advanced Gastric Cancer prnewswire.com ↗
Merck KGaA, Darmstadt, Germany , and Pfizer Inc. (NYSE: PFE ) today announced that the Phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival (OS) with single-agent avelumab* compared with physician's choice of chemotherapy. |
| 2017-11-28 | Pfizer | Results Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Phase III JAVELIN Gastric 300 Study in Patients with Pre-Treated Advanced Gastric Cancer pfizer.com ↗
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival (OS) with single-agent avelumab* compared with physician's choice of chemotherapy. |
| 2017-09-27 | Merck KGaA, Darmstadt, Germany | Regulatory Bavencio (avelumab) Approved for Merkel Cell Carcinoma in Japan prnewswire.com ↗ |
| 2017-09-27 | Pfizer | Regulatory Bavencio (avelumab) Approved for Merkel Cell Carcinoma in Japan pfizer.com ↗
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO® (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan. |
| 2017-09-21 | Merck KGaA, Darmstadt, Germany | Regulatory European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma prnewswire.com ↗ |
| 2017-09-20 | Pfizer | Regulatory European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma pfizer.com ↗
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. |
| 2017-08-01 | Merck KGaA, Darmstadt, Germany | Regulatory Opinión positiva del CHMP de la EMA sobre el uso de avelumab para el tratamiento del carcinoma de células de Merkel metastásico prnewswire.com ↗
ha recomendado la autorización de avelumab* en monoterapia para el tratamiento de pacientes adultos con carcinoma de células de Merkel metastásico (CCMm) |
| 2017-07-21 | Merck KGaA, Darmstadt, Germany | Regulatory EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma prnewswire.com ↗ |
| 2017-07-21 | Pfizer | Regulatory EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2017-05-09 | Pfizer | Regulatory FDA Grants Second Approval for BAVENCIO® (avelumab) pfizer.com ↗
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announce that the US Food and Drug Administration (FDA) has granted accelerated approval for BAVENCIO® (avelumab) Injection for a second indication. |
| 2017-05-09 | Pfizer | Regulatory FDA Grants BAVENCIO® (avelumab) Approval for a Common Type of Advanced Bladder Cancer pfizer.com ↗
These indications are approved under accelerated approval based on tumor response and duration of response. |
| 2017-03-23 | Pfizer | Regulatory FDA Grants Approval for BAVENCIO® (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma pfizer.com ↗
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). |
| 2017-02-28 | Pfizer | Regulatory FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review pfizer.com ↗
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2017, for avelumab in this indication. |
| 2016-11-29 | Pfizer | Regulatory FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review pfizer.com ↗
today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab. |
| 2016-10-30 | Pfizer | Regulatory European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma pfizer.com ↗
Validation of the MAA confirms that submission is complete and begins the EMA's centralized review process.* |
| 2016-10-09 | Pfizer | Results Pfizer Presents Promising New Immunotherapy Combination Data With INLYTA® (axitinib) In Advanced Renal Cell Carcinoma (RCC) pfizer.com ↗
The data suggest evidence of anti-tumor activity for INLYTA in combination with avelumab and were presented during a poster discussion session at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology being held in Copenhagen, Denmark. |
| 2016-06-06 | Pfizer | Results ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma pfizer.com ↗
Tumor responses were rapid, with 78.6% of patients (22 of 28) responding within 7 weeks of starting treatment, and durable, with 82.1% of patients (23 of 28) still responding at the time of analysis. |
| 2015-11-24 | Pfizer | Regulatory Merck KGaA, Darmstadt, Germany, and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan Medicinal Products pfizer.com ↗
The COMP positive opinion is for the cancer immunotherapy avelumab, for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. |
| 2015-11-18 | Pfizer | Regulatory Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2015-10-07 | Pfizer | Regulatory Merck KGaA, Darmstadt, Germany, and Pfizer Announce Investigational Immunotherapy Avelumab Receives FDA Fast Track Designation for Metastatic Merkel Cell Carcinoma pfizer.com ↗
Merck KGaA, Darmstadt, Germany, and Pfizer today announced that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. |
All press releases naming this drug 137 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 137 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 275 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Avelumab | “Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune...” NCT07224971 ↗267“We aimed to investigate the activity of sequential transarterial chemoembolisation (TACE) and stereotactic body radiotherapy followed by avelumab (an anti-PD-L1 drug) for...” PMID 36529152 ↗ Dec 2022 “TTI-621 will be given in combination with one of the following programmed death-1 (PD-1) or programmed death-ligand-1 (PD-L1) inhibitors: nivolumab, pembrolizumab, durvalumab,...” NCT02890368 ↗ “therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab, or currently approved standard of care treatment, either alone or in combination” NCT05358938 ↗ “IV infusion of avelumab (10 mg/kg over 1 hour) once every 2 weeks.” NCT02999087 ↗ “Avelumab 10 mg/kg will be administered every two weeks.” NCT04258956 ↗ “PD-L1 inhibiting monoclonal antibody Avelumab” NCT03399071 ↗ “either avelumab, trastuzumab or cetuximab” NCT05069935 ↗ “XL092 + Avelumab Dose-Escalation Cohorts” NCT03845166 ↗ “Immunotherapy: Avelumab (6 cycles)” NCT06686381 ↗ “Avelumab 10 mg/kg IV 1 q 2 weeks” NCT04510597 ↗ |
| Known as | AVE | “IDH1-vac combined with avelumab (AVE), an immune checkpoint inhibitor (ICI) targeting programmed death-ligand 1 (PD-L1).” PMID 35599302 ↗ May 2022 |
| Known as | Bavencio | “The drug in this study is: Avelumab (also known as BAVENCIO®)” NCT03747419 ↗ |
| Known as | MSB-0010682 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833373 ↗ |
| Known as | MSB0010718C | “A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A...” NCT02603432 ↗17“This is a single arm, open label, phase II study to evaluate the activity of avelumab (MSB0010718C) in patients with metastatic or locally advanced urothelial cancer considered...” NCT03891238 ↗ “A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS...” NCT02718417 ↗ “A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL...” NCT02580058 ↗ “A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed...” NCT03391479 ↗ “A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet” NCT02395172 ↗ “Avelumab (formerly MSB0010718C) is a human immunoglobulin G1 (IgG1) anti-PD-L1 monoclonal antibody131 that utilizes both adaptive and innate immune mechanisms.” NCT03964532 ↗ “A PHASE 1 PHARMACOKINETIC-PHARMACODYNAMIC STUDY OF AVELUMAB (MSB0010718C) IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED STAGE CLASSICAL HODGKIN'S LYMPHOMA” NCT02603419 ↗ “An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies” NCT03815643 ↗ “OF AVELUMAB (MSB0010718C) IN COMBINATION WITH CHEMOTHERAPY WITH OR WITHOUT OTHER ANTI-CANCER IMMUNOTHERAPIES” NCT03317496 ↗ “To test the maximum tolerated dose of avelumab (MSB0010718C) in combination with axitinib (AG-013736)” NCT02493751 ↗ |
| Action | Inhibit | “a programmed death-ligand 1 (PD-L1) inhibitor” PMID 32849281 ↗ Aug 2020 |
| Modality | Monoclonal antibody | “Avelumab, an anti-programmed death-ligand 1 monoclonal antibody” PMID 31553054 ↗ Nov 2019 |
| Route | Intravenous | “received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks” NCT01772004 ↗ |
| Target | CD274 | “avelumab (anti-programmed death ligand 1 antibody)” PMID 37236636 ↗ May 2023 |