Tremelimumab
Monoclonal antibody targets CTLA4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hepatocellular carcinoma 1 milestone | |||||
| Filed | US (FDA) | — | hepatocellular carcinoma | 2022-04-25 | “AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US” astrazeneca.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Imjudo | — | 2023-02-20 | europa.eu ↗ |
Trials 245 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 06 trials | ||||||
| Phase 0 | NCT06824363 | May 2026 → Jan 2027 expected | esophageal adenocarcinoma, gastric adenocarcinoma | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 0 | NCT04223648 | Aug 2020 → Feb 2022 | melanoma | Yale University | Withdrawn | No outcome recorded Stop: Business |
| Phase 0 | NCT04005690 | Aug 2019 → Jun 2027 expected | pancreatic ductal adenocarcinoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 0 | NCT03132467 | Jun 2017 → Jan 2019 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 0 | NCT02812420 | Mar 2017 → Dec 2027 expected | hydronephrosis, infiltrating bladder urothelial carcinoma sarcomatoid variant, kidney pelvis sarcomatoid transitional cell carcinoma, micropapillary variant infiltrating bladder urothelial carcinoma +3 | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 0 | NCT02626130 | Mar 2016 → Jun 2022 | clear cell renal carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 155 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT06564623 | May 2025 → Mar 2029 expected | biliary tract cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 1 | NCT06710223 | Jan 2025 → Jun 2027 expected | hepatocellular carcinoma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 1 | NCT06058663 | Jun 2024 → Nov 2026 expected | intrahepatic cholangiocarcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT05701488 | Apr 2023 → Oct 2026 expected | hepatocellular carcinoma | Jiping Wang, MD, PhD | Recruiting | No outcome recorded |
| Phase 1 | NCT05928962 | Oct 2022 → Aug 2023 | melanoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT04605731 | Aug 2021 → Feb 2027 expected | hepatocellular carcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03963414 | Sep 2020 → Dec 2021 | small cell lung carcinoma | University of Nebraska | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04073160 | Jun 2020 → Jul 2021 | urinary bladder cancer | Daniel George, MD | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03802747 | Aug 2019 → Dec 2023 | colorectal cancer | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 1 | NCT03923270 | Jun 2019 → Jun 2023 overdue | small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04287894 | Dec 2018 → Nov 2024 | non-small cell lung carcinoma | The Netherlands Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03452332 | Jul 2018 → Aug 2023 | cervical adenocarcinoma, cervical squamous cell carcinoma, vaginal adenocarcinoma, vaginal squamous cell carcinoma +2 | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03277482 | Jun 2018 → Jul 2022 | cervical carcinoma, endometrial cancer, ovarian carcinoma, vaginal cancer +1 | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03509012 | May 2018 → Dec 2020 | head and neck squamous cell carcinoma, non-small cell lung carcinoma, small cell lung carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03275597 | Feb 2018 → Jul 2020 | non-small cell lung carcinoma | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03085849 | Dec 2017 → Nov 2018 | small cell lung carcinoma | Catherine Shu | Completed | No outcome recorded |
| Phase 1 | NCT03144778 | Jul 2017 → Mar 2021 | oropharynx squamous cell carcinoma | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 1 | NCT03005002 | Jun 2017 → Nov 2019 | Lynch syndrome 1, Lynch syndrome 4, Lynch syndrome 5, metastatic carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03122496 | Apr 2017 → Jun 2022 | thyroid gland undifferentiated (anaplastic) carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03089645 | Mar 2017 → Jun 2020 | cancer | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT03019003 | Mar 2017 → Sep 2024 | head and neck cancer | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02762006 | Dec 2016 → Nov 2020 | renal cell carcinoma | Moshe Ornstein | Completed | No outcome recorded |
| Phase 1 | NCT02716805 | Dec 2016 → Feb 2018 | plasma cell myeloma | Ludwig Institute for Cancer Research | Terminated | No outcome recorded |
| Phase 1 | NCT02978482 | Dec 2016 → Jan 2018 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02754856 | Aug 2016 → Jan 2023 | colorectal cancer, metastatic carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02868632 | Aug 2016 → Mar 2019 | malignant pancreatic neoplasm | NYU Langone Health | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02549651 | Jul 2016 → Feb 2019 | diffuse large B-cell lymphoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT02718911 | Jun 2016 → Dec 2018 | cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02658214 | Apr 2016 → Nov 2019 | esophageal squamous cell carcinoma, fallopian tube neoplasm, gastric neoplasm, gastroesophageal cancer +6 | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02705482 | Mar 2016 → Aug 2019 | cancer | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT02639026 | Jan 2016 → Jun 2023 | breast cancer, malignant pancreatic neoplasm, melanoma, metastatic malignant neoplasm +1 | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02485990 | Jan 2016 → Mar 2020 | primary peritoneal carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 1 | NCT02616185 | Dec 2015 → Feb 2021 | prostate neoplasm | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02586987 | Dec 2015 → Jul 2018 | biliary tract cancer, breast cancer, colorectal cancer, gastroesophageal cancer +4 | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02537418 | Oct 2015 → Jul 2018 overdue | cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02301130 | Nov 2014 → Dec 2017 | cancer | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 1 | NCT02262741 | Oct 2014 → Sep 2017 | head and neck squamous cell carcinoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT02261220 | Oct 2014 → Jan 2020 | cancer | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT02141347 | May 2014 → Jan 2017 | malignant mesothelioma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02117219 | May 2014 → Apr 2019 | myelodysplastic syndrome | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT02141542 | May 2014 → Sep 2020 | metastatic melanoma | F. Stephen Hodi, MD | Completed | No outcome recorded |
| Phase 1 | NCT02040064 | Jan 2014 → Mar 2016 | non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 1 | NCT01975831 | Dec 2013 → Dec 2019 | breast cancer, cervical cancer, colorectal cancer, ovarian cancer +1 | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1 | NCT02000947 | Oct 2013 → Sep 2019 | non-small cell lung carcinoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01938612 | Sep 2013 → Mar 2018 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04274816 | Jul 2012 → Feb 2014 | cutaneous melanoma | A.J.M. van den Eertwegh | Completed | No outcome recorded |
| Phase 1 | NCT01334099 | Jul 2010 → Mar 2013 | breast cancer | University Health Network, Toronto | Terminated | No outcome recorded |
| Phase 1 | NCT01103635 | Feb 2010 → May 2016 | metastatic melanoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 1 | NCT00880854 | Jun 2009 → Feb 2011 | urinary bladder cancer | University of Wisconsin, Madison | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00702923 | Jul 2008 → Sep 2011 | prostate cancer | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00556023 | Jun 2008 → Aug 2011 | malignant pancreatic neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00585000 | Dec 2007 → Jan 2010 | melanoma | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT00372853 | Nov 2006 → May 2010 | renal cell carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00431275 | Jun 2006 → Feb 2008 | melanoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00090896 | Apr 2004 → Jul 2008 | cutaneous melanoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1/234 trials · 3 met primary · 1 missed | ||||||
| Phase 1/2 | NCT06608940 | Nov 2025 → Jan 2027 | hepatocellular carcinoma | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06911255 | Apr 2025 → Mar 2028 expected | hepatocellular carcinoma | Yoon Jun Kim | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05932199 | Jul 2024 → May 2028 expected | mesothelioma | Baylor College of Medicine | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04989218 | Jan 2023 → Mar 2024 | cholangiocarcinoma | University of Alabama at Birmingham | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05120622 | Sep 2021 → May 2022 | bladder carcinoma in situ | University of British Columbia | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03871036 | May 2019 → Sep 2023 | urothelial carcinoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03581487 | Apr 2019 → Oct 2025 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03837899 | Mar 2019 → Feb 2023 overdue | childhood malignant neoplasm, hematopoietic and lymphoid cell neoplasm | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03549715 | Dec 2018 → Jun 2024 | infiltrating bladder urothelial carcinoma | Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie | Unknown | Mixed |
| Phase 1/2 | NCT03693612 | Nov 2018 → Jun 2021 | neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT03539822 | Oct 2018 → Jun 2028 expected | colorectal cancer, esophageal adenocarcinoma, gastric cancer, hepatocellular carcinoma | Anwaar Saeed | Recruiting | Met primary |
| Phase 1/2 | NCT03618134 | Oct 2018 → Jun 2023 | human papilloma virus infection, oropharynx squamous cell carcinoma | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03784066 | Aug 2018 → Mar 2025 overdue | oral cavity squamous cell carcinoma | Universitaire Ziekenhuizen KU Leuven | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03283605 | Jul 2018 → Jul 2024 | head and neck squamous cell carcinoma | University of Montreal Hospital Centre (CHUM) | Unknown | No outcome recorded |
| Phase 1/2 | NCT03518606 | Jun 2018 → Apr 2022 | breast cancer, cervical cancer, head and neck cancer, prostate cancer | UNICANCER | Completed | No outcome recorded |
| Phase 1/2 | NCT03751761 | Jun 2018 → Aug 2023 | gastric cancer | Asan Medical Center | Completed | Met primary |
| Phase 1/2 | NCT03522584 | May 2018 → Dec 2021 | head and neck squamous cell carcinoma | University of Washington | Terminated | No outcome recorded |
| Phase 1/2 | NCT03164772 | Dec 2017 → Oct 2021 | non-small cell lung carcinoma | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1/2 | NCT03206073 | Dec 2017 → Sep 2020 | colorectal adenocarcinoma, refractory malignant neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT03317158 | Nov 2017 → Dec 2028 expected | urinary bladder cancer, urothelial carcinoma | Noah Hahn, M.D. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03249142 | Oct 2017 → Dec 2024 | ovarian cancer | ARCAGY/ GINECO GROUP | Completed | No outcome recorded |
| Phase 1/2 | NCT03202758 | Aug 2017 → Jan 2023 | colorectal cancer | Centre Georges Francois Leclerc | Completed | Met primary |
| Phase 1/2 | NCT03116529 | Jun 2017 → Jun 2024 | soft tissue sarcoma | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03212469 | Jun 2017 → Feb 2025 | esophageal cancer, head and neck squamous cell carcinoma, lung cancer | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 1/2 | NCT02643303 | Dec 2016 → Feb 2022 | breast cancer, cutaneous neuroendocrine carcinoma, head and neck squamous cell carcinoma, kidney cancer +6 | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1/2 | NCT02962063 | Nov 2016 → Nov 2026 expected | esophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02735239 | Jun 2016 → Jun 2022 | esophageal cancer | Ludwig Institute for Cancer Research | Completed | No outcome recorded |
| Phase 1/2 | NCT02571725 | Feb 2016 → Dec 2020 overdue | fallopian tube cancer, ovarian cancer, peritoneal neoplasm | New Mexico Cancer Research Alliance | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02499328 | Aug 2015 → Feb 2020 | head and neck squamous cell carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1/2 | NCT02340975 | Mar 2015 → Apr 2019 | adenocarcinoma | MedImmune LLC | Completed | Missed primary |
| Phase 1/2 | NCT02311361 | Mar 2015 → Oct 2019 | malignant pancreatic neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT02205333 | Aug 2014 → Apr 2016 | aggressive B-cell non-Hodgkin lymphoma, cancer | MedImmune LLC | Terminated | No outcome recorded |
| Phase 1/2 | NCT01853618 | May 2013 → Jun 2017 | biliary tract cancer, hepatocellular carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT00075192 | Mar 2004 → Mar 2006 | prostate neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 2124 trials · 3 met primary · 9 missed | ||||||
| Phase 2 | NCT06855225 | Oct 2026 → May 2027 expected | combined hepatocellular carcinoma and cholangiocarcinoma | Mehmet Akce | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07288034 | Apr 2026 → Oct 2028 expected | non-small cell lung carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07511504 | Apr 2026 → Aug 2027 expected | hepatocellular carcinoma | OHSU Knight Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07489976 | Apr 2026 → Apr 2030 expected | hepatocellular carcinoma | Ju Dong Yang | Recruiting | No outcome recorded |
| Phase 2 | NCT07122089 | Feb 2026 → Jan 2030 expected | hepatocellular carcinoma | Center Eugene Marquis | Recruiting | No outcome recorded |
| Phase 2 | NCT07174570 | Jan → Nov 2026 expected | hepatocellular carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06994299 | Oct 2025 → Jul 2027 | hepatocellular carcinoma | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT07168668 | Sep 2025 → May 2028 expected | hepatocellular carcinoma | Chang Gung Memorial Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07081633 | Aug 2025 → Nov 2026 expected | hepatocellular carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06999707 | May 2025 → May 2030 expected | hepatocellular carcinoma | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Show all 124 trials opens the full record — a long page | ||||||
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06904170 | Nov 2025 → Sep 2029 expected | hepatocellular carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 322 trials · 4 met primary · 6 missed | ||||||
| Phase 3 | NCT07166406 | Feb 2026 → Mar 2029 expected | hepatocellular carcinoma | NRG Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT07027436 | Nov 2025 → Oct 2027 expected | hepatocellular carcinoma | Hamilton Health Sciences Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT06841172 | Jul 2025 → Jul 2027 expected | hepatocellular carcinoma | Shandong Cancer Hospital and Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT06921785 | May 2025 → Mar 2030 expected | hepatocellular carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05557838 | Feb 2023 → Sep 2026 overdue | hepatocellular carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05301842 | Mar 2022 → Feb 2026 overdue | hepatocellular carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT04585490 | Aug 2021 → Dec 2026 expected | non-small cell lung carcinoma | Stanford University | Recruiting | No outcome recorded |
| Phase 3 | NCT04960709 | Aug 2021 → Mar 2026 overdue | urinary bladder carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03703297 | Sep 2018 → Jan 2024 overdue | small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03682068 | Sep 2018 → Jun 2026 overdue | urothelial carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03288532 | Jul 2018 → Jul 2024 overdue | renal cell carcinoma | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT03298451 | Oct 2017 → Aug 2021 overdue | hepatocellular carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03084471 | Jun 2017 → Mar 2020 | high grade malignant neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03164616 | Jun 2017 → Mar 2021 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Mixed |
| Phase 3 | NCT03043872 | Mar 2017 → Jan 2020 overdue | small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02542293 | Nov 2015 → Sep 2020 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 3 | NCT02516241 | Nov 2015 → Jan 2020 overdue | urothelial carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 3 | NCT02551159 | Oct 2015 → Jul 2020 | head and neck squamous cell carcinoma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT02369874 | Sep 2015 → Sep 2018 | head and neck squamous cell carcinoma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT02453282 | Jul 2015 → Oct 2018 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Mixed |
| Phase 3 | NCT02352948 | Jan 2015 → Feb 2018 | non-small cell lung carcinoma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00257205 | Mar 2006 → Aug 2010 | melanoma | AstraZeneca | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT02563925 | Sep 2015 → Jul 2021 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT00584493 | May 2008 → ? | — | Pfizer | No longer available | No outcome recorded |
| — | NCT05345678 | — | hepatocellular carcinoma | AstraZeneca | Approved for marketing | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT07391670 Background | Mar 2026 → Aug 2027 expected | cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT07175441 Comparator | Apr 2026 → Apr 2027 expected | hepatocellular carcinoma | Riboscience, LLC. | Recruiting | No outcome recorded |
| Phase 2 | NCT06880523 Background | Oct 2025 → Jan 2028 expected | hepatocellular carcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05451043 Background | Jul 2023 → Oct 2026 expected | cholangiocarcinoma, hepatocellular carcinoma, malignant pancreatic neoplasm | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT03606967 Background | Apr 2021 → Dec 2026 expected | invasive breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT04221555 Comparator | May 2020 → Apr 2025 | adenocarcinoma | Asan Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03847649 Comparator | Mar 2020 → Apr 2030 expected | cancer | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03737968 Comparator | Jan 2019 → Oct 2023 | hypopharyngeal carcinoma, oral cavity squamous cell carcinoma, oropharyngeal carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT03994393 Comparator | Oct 2018 → Jun 2023 | lung cancer | University of Sydney | Unknown | No outcome recorded |
| Phase 2 | NCT03057106 Comparator | Mar 2017 → Feb 2020 overdue | lung cancer | Canadian Cancer Trials Group | Active not recruiting | Missed primary |
| Phase 2 | NCT02592551 Comparator | May 2016 → Aug 2019 | mesothelioma | Baylor College of Medicine | Completed | Missed primary |
| Phase 2 | NCT00378482 Background | Mar 2007 → Oct 2023 | colorectal neoplasm, melanoma, prostate neoplasm, renal cell carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2/3 | NCT06109272 Comparator | Jan 2024 → Jan 2027 expected | hepatocellular carcinoma | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06840782 Background | Sep 2025 → Feb 2030 expected | non-small cell lung carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 43
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | AstraZeneca | Results Imfinzi plus Imjudo combined with lenvatinib and TACE reduced the risk of disease progression or death by 30% in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial astrazeneca.com ↗
The median PFS was 13.0 months for this regimen versus 9.8 months for TACE. |
| 2026-05-14 | AstraZeneca | Results Perioperative Imfinzi plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the Phase III VOLGA trial astrazeneca.com ↗
Perioperative Imfinzi plus Imjudo (tremelimumab) in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favourable trend for OS |
| 2026-04-02 | AstraZeneca | Results Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial astrazeneca.com ↗ |
| 2024-09-16 | AstraZeneca | Results Imfinzi plus Imjudo demonstrated unprecedented overall survival in advanced liver cancer with one in five patients surviving five years in HIMALAYA Phase III trial astrazeneca.com ↗
Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment. |
| 2023-08-16 | AstraZeneca | Results AstraZeneca data at WCLC advance ambition to have an AstraZeneca medicine for more than half of all patients treated for lung cancer by 2030 astrazeneca.com ↗
Data will also be shared from new exploratory subgroup analyses of the POSEIDON Phase III trial describing patients deriving long-term benefit from the combination of Imfinzi , Imjudo (tremelimumab) and chemotherapy in the metastatic NSCLC setting. |
| 2023-06-29 | AstraZeneca | Results Imfinzi plus Imjudo demonstrated sustained overall survival benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA Phase III trial astrazeneca.com ↗
Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at four years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment. |
| 2023-02-22 | AstraZeneca | Regulatory Imfinzi plus Imjudo approved in the EU for patients with advanced liver and non-small cell lung cancers astrazeneca.com ↗
AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations have been approved in the European Union (EU) for the treatment of advanced liver and lung cancers. |
| 2022-12-28 | AstraZeneca | Regulatory Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers astrazeneca.com ↗
AstraZeneca’s immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) have been approved in Japan for the treatment of three cancer types: advanced liver, biliary tract and lung. |
| 2022-12-19 | AstraZeneca | Regulatory Imfinzi plus Imjudo recommended for approval in the EU by CHMP for the treatment of advanced liver and lung cancers astrazeneca.com ↗
The concurrent positive opinions recommend authorising Imfinzi in combination with Imjudo for 1st-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC); and Imfinzi in combination with Imjudo and platinum-based chemotherapy for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). |
| 2022-11-11 | AstraZeneca | Regulatory Imfinzi and Imjudo with chemotherapy approved in the US for patients with metastatic non-small cell lung cancer astrazeneca.com ↗
AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy has been approved in the US for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). |
| 2022-10-24 | AstraZeneca | Regulatory Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer astrazeneca.com ↗
AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. |
| 2022-09-12 | AstraZeneca | Results Imfinzi plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 Phase III trial, reducing the risk of death by 24% in additional follow-up astrazeneca.com ↗
HIMALAYA Phase III trial exploratory results support the benefit of tremelimumab added to Imfinzi in unresectable liver cancer regardless of aetiology |
| 2022-09-11 | AstraZeneca | Results Imfinzi and tremelimumab with chemotherapy demonstrated sustained survival benefit in metastatic non-small cell lung cancer, nearly doubling the number of patients alive after three years vs. chemotherapy astrazeneca.com ↗
These late-breaking results were presented today at the European Society of Medical Oncology (ESMO) Congress 2022 (Abstract #LBA59). |
| 2022-04-25 | AstraZeneca | Regulatory Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi astrazeneca.com ↗ |
| 2022-01-18 | AstraZeneca | Results Imfinzi plus tremelimumab demonstrated unprecedented survival in 1st-line unresectable liver cancer with 31% of patients alive at three years astrazeneca.com ↗
A single priming dose of tremelimumab plus Imfinzi every four weeks reduced risk of death by 22% in HIMALAYA Phase III trial |
| 2022-01-13 | AstraZeneca | Results AstraZeneca aims to redefine liver, biliary tract and prostate cancer treatment with practice-changing Imfinzi and Lynparza data at ASCO GI and GU astrazeneca.com ↗
A late-breaking presentation will feature results from the HIMALAYA Phase III trial showing a statistically significant and clinically meaningful overall survival (OS) benefit with a single priming dose of tremelimumab added to Imfinzi (durvalumab) in 1st-line unresectable liver cancer. |
| 2021-10-15 | AstraZeneca | Results Imfinzi plus tremelimumab significantly improved overall survival in HIMALAYA Phase III trial in 1st-line unresectable liver cancer astrazeneca.com ↗
Trial met primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib |
| 2021-09-09 | AstraZeneca | Results Imfinzi and tremelimumab with chemotherapy improved progression-free survival by 28% and overall survival by 23% in 1st-line Stage IV non-small cell lung cancer vs. chemotherapy astrazeneca.com ↗
The results of POSEIDON confirm that tremelimumab added to Imfinzi and chemotherapy is an effective, well-tolerated treatment in this setting. |
| 2021-09-02 | AstraZeneca | Results AstraZeneca lung and breast cancer data at WCLC and ESMO 2021 underscore ambition to revolutionise outcomes for patients astrazeneca.com ↗
A Presidential Symposium will present results from the final analysis of the POSEIDON Phase III trial at WCLC showing a significant, clinically meaningful survival benefit for the combination of Imfinzi (durvalumab), tremelimumab and chemotherapy in metastatic non-small cell lung cancer (NSCLC). |
| 2021-05-19 | AstraZeneca | Results AstraZeneca ASCO 2021 data support ambition to revolutionise cancer outcomes by treating earlier and transforming the patient experience astrazeneca.com ↗
T-cell receptor pharmacodynamics associated with survival and response to tremelimumab (T) in combination with durvalumab (D) in patients (pts) with unresectable hepatocellular carcinoma (uHCC). |
| 2021-05-07 | AstraZeneca | Results Imfinzi and tremelimumab with chemotherapy demonstrated overall survival benefit in POSEIDON trial for 1st-line Stage IV non-small cell lung cancer astrazeneca.com ↗ |
| 2021-02-05 | AstraZeneca | Results Update on KESTREL Phase III trial of Imfinzi with or without tremelimumab in the 1st-line treatment of recurrent or metastatic head and neck cancer astrazeneca.com ↗
Also, the combination of Imfinzi plus tremelimumab did not indicate an OS benefit in ‘all-comer’ patients, a secondary endpoint. |
| 2020-09-08 | AstraZeneca | Results AstraZeneca aims to transform cancer treatment and advance clinical practice with data presented at ESMO 2020 astrazeneca.com ↗
The trial did not meet its primary endpoints. |
| 2020-05-29 | AstraZeneca | Results Imfinzi showed a sustained overall survival benefit in 1st-line extensive-stage small cell lung cancer in the Phase III CASPIAN trial astrazeneca.com ↗
The second experimental arm in the CASPIAN trial testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to Imfinzi and chemotherapy showed a trend towards OS, but did not reach statistical significance compared to chemotherapy alone. |
| 2020-05-29 | AstraZeneca | Results Imfinzi plus tremelimumab demonstrated promising clinical activity and tolerability in patients with advanced liver cancer astrazeneca.com ↗
Results from the global Phase II Study 22 trial testing AstraZeneca’s tremelimumab, an anti-CTLA4 antibody, added to Imfinzi (durvalumab) demonstrated promising clinical activity and tolerability in patients with advanced hepatocellular carcinoma (HCC). |
| 2020-03-30 | AstraZeneca | Results Imfinzi approved in the US for extensive-stage small cell lung cancer astrazeneca.com ↗ |
| 2020-03-17 | AstraZeneca | Results Imfinzi confirmed a sustained overall survival benefit in final analysis of the Phase III CASPIAN trial in 1st-line extensive-stage small cell lung cancer astrazeneca.com ↗
The second experimental arm testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to Imfinzi and SoC did not meet its primary endpoint of demonstrating a statistically significant improvement in OS in this analysis. |
| 2020-03-06 | AstraZeneca | Results Update on Phase III DANUBE trial for Imfinzi and tremelimumab in unresectable, Stage IV bladder cancer astrazeneca.com ↗
The Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints |
| 2020-01-20 | AstraZeneca | Regulatory Imfinzi and tremelimumab granted Orphan Drug Designation in the US for liver cancer astrazeneca.com ↗
AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation (ODD) in the US for the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer. |
| 2019-10-28 | AstraZeneca | Results Imfinzi and Imfinzi plus tremelimumab delayed disease progression in Phase III POSEIDON trial for 1st-line treatment of Stage IV non-small cell lung cancer astrazeneca.com ↗
AstraZeneca today announced positive progression-free survival (PFS) results for Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody, when added to chemotherapy, from the Phase III POSEIDON trial in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC). |
| 2019-08-21 | AstraZeneca | Results Update on the Phase III NEPTUNE trial of Imfinzi plus tremelimumab in Stage IV non-small cell lung cancer astrazeneca.com ↗
In the primary analysis population of patients whose blood TMB was 20 or more mutations per megabase (mut/Mb), the combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving OS compared to SoC chemotherapy. |
| 2018-12-07 | AstraZeneca | Results Update on the Phase III EAGLE trial of Imfinzi and tremelimumab in advanced head and neck cancer astrazeneca.com ↗
Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy in these hard-to-treat patients. |
| 2018-11-16 | AstraZeneca | Results AstraZeneca provides update on the Phase III MYSTIC trial of Imfinzi and tremelimumab in Stage IV non-small cell lung cancer astrazeneca.com ↗
The combination therapy had an HR of 0.85 (98.77% CI 0.611-1.173; nominal p=0.202); the data support further analysis in exploratory subgroups. |
| 2018-04-24 | AstraZeneca | Results AstraZeneca reports results from the ARCTIC trial in third-line non-small cell lung cancer astrazeneca.com ↗
In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to SoC. |
| 2017-10-16 | AstraZeneca | Results AstraZeneca shares its comprehensive scientific approach at the World Conference on Lung Cancer 2017 astrazeneca.com ↗
When combined with chemotherapy, Imfinzi with or without tremelimumab could be administered safely and demonstrated encouraging preliminary clinical activity in patients with NSCLC in a study conducted by the Canadian Cancer Trials Group [Abstract #8700]. |
| 2017-07-27 | AstraZeneca | Results AstraZeneca reports initial results from the ongoing MYSTIC trial in Stage IV lung cancer astrazeneca.com ↗
Imfinzi plus tremelimumab combination did not meet a primary endpoint of progression-free survival compared to chemotherapy |
| 2016-11-22 | AstraZeneca | Regulatory AstraZeneca head and neck cancer trials resume new patient enrolment as FDA lifts partial clinical hold astrazeneca.com ↗
AstraZeneca today announced that the US FDA has lifted the partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. |
| 2016-10-27 | AstraZeneca | Regulatory AstraZeneca head and neck cancer trials astrazeneca.com ↗
AstraZeneca confirms that the US FDA has placed a partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) in clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines. |
| 2016-02-29 | AstraZeneca | Results AstraZeneca reports top-line result of tremelimumab monotherapy trial in mesothelioma astrazeneca.com ↗
Trial did not meet primary endpoint of improving overall survival in challenging to treat mesothelioma patients with no currently approved treatment options in the second-line setting |
| 2015-06-02 | AstraZeneca | Results AstraZeneca updates on immuno-oncology combinations development programme at the 2015 ASCO Annual Meeting astrazeneca.com ↗
As the frontrunner combination of two immuno-oncology molecules in non-small cell lung cancer, it is demonstrating promising clinical activity, in particular in the majority of patients who have low or no PD-L1 expression. |
| 2015-05-30 | AstraZeneca | Results AstraZeneca and MedImmune present positive immuno-oncology combination data at the 2015 ASCO Annual Meeting astrazeneca.com ↗
Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials. |
| 2015-04-15 | AstraZeneca | Regulatory Tremelimumab granted Orphan Drug Designation by US FDA for treatment of malignant mesothelioma astrazeneca.com ↗
Wednesday, 15 April 2015 AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for the anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma. |
| 2014-06-03 | AstraZeneca | Results AstraZeneca updates on the rapid progress of its oncology pipeline at ASCO 2014 astrazeneca.com ↗
Early data has shown encouraging efficacy for the combination in NSCLC and no dose limiting toxicities across the five dose levels assessed to date. |
All press releases naming this drug 44 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 263 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tremelimumab | “This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent...” NCT03377400 ↗241“CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the...” NCT01008358 ↗ “Tremelimumab (CP-675,206) is a fully human monoclonal antibody binding to cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) on T cells that stimulates the immune system by...” PMID 24907635 ↗ Jun 2014 “combinations such as atezolizumab plus bevacizumab, tremelimumab plus durvalumab, or monotherapies such as lenvatinib, sorafenib, tislelizumab, durvalumab, or pembrolizumab, at...” NCT06841172 ↗ “Radiation Therapy Followed by Durvalumab (MEDI4736) and Tremelimumab And Surgery Versus Radiation Therapy Followed by Surgery for Resectable Hepatocellular Carcinoma.” NCT07027436 ↗ “The first cohort patients will receive tremelimumab (3 mg/kg, single infusion) as immune-attractants combined with exemestane (25 mg daily).” NCT02997995 ↗ “Neoadjuvant Anti-PD-L1 (Durvalumab/MEDI4736) Plus Anti-CTLA-4 (Tremelimumab) and Radiation for High Risk Soft-Tissue Sarcoma” NCT03116529 ↗ “Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells.” NCT04989218 ↗ “STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks)” NCT06364007 ↗ “Other alternatives include nivolumab-ipilimumab-chemotherapy or durvalumab-tremelimumab-chemotherapy association.” NCT06840782 ↗ “Patients will receive Durvalumumab + Tremelimumab if Bevacizumab is contraindicated.” NCT05620771 ↗ |
| Known as | CP-675 | “CP-675” NCT03618134 ↗ |
| Known as | CP-675,206 | “CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the...” NCT01008358 ↗21“Tremelimumab (CP-675,206) is a fully human monoclonal antibody binding to cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) on T cells that stimulates the immune system by...” PMID 24907635 ↗ Jun 2014 “OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (CTLA4-blocking monoclonal antibody; CP-675,206).” NCT00090896 ↗ “Patients receive ticilimumab (CP-675,206) IV over 2 hours on day 1.” NCT00471887 ↗ “Anti-CTLA4 monoclonal antibody (CP-675,206)” NCT00610857 ↗ “CP-675,206 (Tremelimumab)” NCT00378482 ↗ “CP-675206” NCT03618134 ↗ |
| Known as | Imjudo | “the FDA approved tremelimumab (Imjudo) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma.” PMID 37676259 ↗ Jan 20241“Durvalumab (Imfinzi®) With Tremelimumab (Imjudo®)” NCT05063565 ↗ |
| Known as | PF-06753388 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108658 ↗ |
| Known as | Ticilimumab | “Patients receive ticilimumab (CP-675,206) IV over 2 hours on day 1.” NCT00471887 ↗ |
| Known as | treme | “tremelimumab (treme), an IgG2 monoclonal antibody blocking cytotoxic T-lymphocyte-associated protein- (CTLA-4)” PMID 34772758 ↗ Nov 20211“Drug: tremelimumab (treme)” NCT02499328 ↗ |
| Known as | Tremelimumab (genetical recombination) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108658 ↗ |
| Known as | Tremelimumab actl | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108658 ↗ |
| Known as | Tremelimumab astrazeneca | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108658 ↗ |
| Action | Inhibit | “CTLA4-blocking antibody tremelimumab” PMID 18452610 ↗ May 2008 |
| Modality | Monoclonal antibody | “monoclonal antibody tremelimumab” PMID 18452610 ↗ May 2008 |
| Route | Intravenous | “Patients receive CP-675,206 IV” NCT00090896 ↗ |
| Target | CTLA4 | “CTLA4-blocking antibody tremelimumab” PMID 18452610 ↗ May 2008 |