Drugs / Leucovorin
last change 2 days ago re-read 8 days ago

Leucovorin

Small molecule

Developed for
colorectal cancer · malignant pancreatic neoplasm · hepatocellular carcinoma · gastric cancer · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · rectal cancer · gastroesophageal junction adenocarcinoma
+137 more · metastatic malignant neoplasm · esophageal cancer · gastric adenocarcinoma · biliary tract cancer · rectum adenocarcinoma · esophageal adenocarcinoma · metastasis from malignant tumor of colon · gastroesophageal cancer · colorectal neoplasm · colon carcinoma · cancer of unknown primary site · colorectal carcinoma · non-small cell lung carcinoma · cancer · gastroesophageal adenocarcinoma · intrahepatic cholangiocarcinoma · breast cancer · gastric neoplasm · rectal carcinoma · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · cholangiocarcinoma · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · lymphoma · metastatic neoplasm · colon adenocarcinoma · colorectal adenocarcinoma · pancreatic neoplasm · autism spectrum disorder · carcinoma of esophagus · digestive system cancer · esophageal squamous cell carcinoma · head and neck squamous cell carcinoma · neoplasm · peritoneal carcinomatosis · rectal neoplasm · head and neck cancer · HIV infectious disease · leukemia · neoplasm of esophagus · pancreatic exocrine neoplasm · squamous cell carcinoma · triple-negative breast carcinoma · adenocarcinoma · appendix cancer · carcinoid tumor · cutaneous neuroendocrine carcinoma · Down syndrome · extrahepatic bile duct carcinoma · gallbladder cancer · gallbladder carcinoma · gastric carcinoma · gastric cardia adenocarcinoma · high grade malignant neoplasm · malignant colon neoplasm · malignant exocrine pancreas neoplasm · nasal cavity and paranasal sinus neoplasm · nasopharyngeal carcinoma · neoplastic syndrome · ovarian cancer · pancreas disorder · pancreatic acinar cell carcinoma · pancreatic endocrine carcinoma · peritoneal carcinoma · pneumocystosis · primary peritoneal carcinoma · small intestine adenocarcinoma · urothelial carcinoma · acute lymphoblastic leukemia · adenocarcinoma of gallbladder and extrahepatic biliary tract · adult glioblastoma · AIDS-related primary central nervous system lymphoma · ampulla of vater adenocarcinoma · anaplastic astrocytoma · anaplastic oligoastrocytoma · anaplastic oligodendroglioma · appendix carcinoma · autism · B-cell acute lymphoblastic leukemia · B-cell adult acute lymphocytic leukemia · B-cell childhood acute lymphoblastic leukemia · bile duct adenocarcinoma · bile duct cancer · biliary tract neoplasm · bladder urachal carcinoma · breast neoplasm · Burkitt lymphoma · carcinoma · carcinoma of the ampulla of vater · chemotherapy-induced oral mucositis · colonic disorder · diffuse gastric adenocarcinoma · digestive system carcinoma · digestive system neoplasm · digestive system neuroendocrine neoplasm · endometrial cancer · Epstein-Barr virus-associated lymphoproliferative disorder · extragonadal germ cell tumor · extragonadal nonseminomatous germ cell tumor · extragonadal seminoma · extrahepatic bile duct adenocarcinoma · fallopian tube cancer · gastric intestinal type adenocarcinoma · gastrointestinal stromal tumor · giant cell glioblastoma · glioblastoma · gliosarcoma · head and neck carcinoma · hepatitis C virus infection · hyperhomocysteinemia · liver and intrahepatic bile duct neoplasm · liver cancer · lung cancer · malignant testicular germ cell tumor · metastatic malignant neoplasm in the brain · metastatic malignant neoplasm in the colon · mucinous ovarian cancer · multiple sclerosis · neuroendocrine carcinoma · neuroendocrine neoplasm · non-Hodgkin lymphoma · ovarian carcinoma · ovarian germ cell tumor · pancreatic adenosquamous carcinoma · pancreatic neuroendocrine tumor · periampullary adenocarcinoma · post-transplant lymphoproliferative disease · psychotic disorder · sarcoma · small intestine cancer · syndrome caused by partial chromosomal deletion · trisomy 21 · ulcer of lower limbs · undifferentiated pancreatic carcinoma · urachus cancer · urethra cancer
Investigated by
National Cancer Institute (NCI) · Sun Yat-sen University · Alliance for Clinical Trials in Oncology · Sanofi · GERCOR - Multidisciplinary Oncology Cooperative Group · ImmunityBio, Inc.
+550 more · Memorial Sloan Kettering Cancer Center · National Health Research Institutes, Taiwan · National Taiwan University Hospital · Federation Francophone de Cancerologie Digestive · Fudan University · Tianjin Medical University Cancer Institute and Hospital · UNICANCER · Bristol-Myers Squibb · European Organisation for Research and Treatment of Cancer - EORTC · National Cheng-Kung University Hospital · Chang Gung Memorial Hospital · Pfizer · Amgen · China Medical University Hospital · Hoffmann-La Roche · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Washington University School of Medicine · City of Hope Medical Center · Eastern Cooperative Oncology Group · Genentech, Inc. · M.D. Anderson Cancer Center · SWOG Cancer Research Network · Taipei Veterans General Hospital, Taiwan · University of Miami · Merck Sharp & Dohme LLC · Celgene Corporation · Eli Lilly and Company · Ipsen · Jiangsu HengRui Medicine Co., Ltd. · Massachusetts General Hospital · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Tri-Service General Hospital (TSGH) · Mackay Memorial Hospital · NCIC Clinical Trials Group · UNC Lineberger Comprehensive Cancer Center · AIO-Studien-gGmbH · Academic Medical Center - University of Amsterdam · Assistance Publique - Hôpitaux de Paris · Brigham and Women's Hospital · Cancer Institute of the State of São Paulo · Case Comprehensive Cancer Center · Dana-Farber Cancer Institute · Fox Chase Cancer Center · Institut Cancerologie de l'Ouest · Institut du Cancer de Montpellier - Val d'Aurelle · Kaohsiung Medical University Chung-Ho Memorial Hospital · Kaohsiung Veterans General Hospital. · Medical Research Council · Merck KGaA, Darmstadt, Germany · SCRI Development Innovations, LLC · Servier · Taichung Veterans General Hospital · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The Methodist Hospital Research Institute · University Hospital of Crete · University of California, San Francisco · University of Chicago · University of Rochester · University of Southern California · Yonsei University · Agenus Inc. · Akeso · Asan Medical Center · AstraZeneca · Australasian Gastro-Intestinal Trials Group · Brown University · CONKO-Studiengruppe · Canadian Cancer Trials Group · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Cancer Research UK · Cancer and Leukemia Group B · Centre Hospitalier Universitaire Dijon · Changhua Christian Hospital · Chi Mei Medical Hospital · all 556 on the full record

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) WELLCOVORIN — 2026-03-09 fda.gov ↗
Label expansions (3) US (FDA) LEUCOVORIN CALCIUM — 1987-01-30 – 1991-12-12 fda.gov ↗
Approved US (FDA) LEUCOVORIN CALCIUM — 1952-06-20 fda.gov ↗

Trials 760 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT05007587 Jul 2021 → Jun 2022 hepatocellular carcinoma Zhejiang Cancer Hospital Unknown No outcome recorded
Phase 0 NCT03970252 Jul 2019 → May 2024 pancreatic ductal adenocarcinoma Jonsson Comprehensive Cancer Center Completed No outcome recorded
Phase 0 NCT03600623 Sep 2017 → Jul 2020 malignant pancreatic neoplasm, pancreatic exocrine neoplasm University of Alabama at Birmingham Terminated No outcome recorded Stop: Enrollment
Phase 0 NCT02896907 Oct 2016 → Mar 2018 pancreatic adenocarcinoma Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 0 NCT01821612 May 2013 → Nov 2014 pancreatic acinar cell carcinoma, pancreatic ductal adenocarcinoma Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 168 trials
Phase 1 NCT07363408 Dec 2026 → Jul 2027 expected colorectal carcinoma City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT07829185 Dec 2026 → Dec 2029 expected pancreatic ductal adenocarcinoma University of Oklahoma Not yet recruiting No outcome recorded
Phase 1 NCT07859085 Oct 2026 → Mar 2029 expected colorectal neoplasm, pancreatic ductal adenocarcinoma Genentech, Inc. Not yet recruiting No outcome recorded
Phase 1 NCT07060014 Sep 2026 → Sep 2028 expected appendix cancer, small intestine cancer The Methodist Hospital Research Institute Recruiting No outcome recorded
Phase 1 NCT07649655 Jul 2026 → Mar 2028 expected colorectal cancer Shanghai EpimAb Biotherapeutics Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT07030283 Dec 2025 → Jul 2028 expected pancreatic ductal adenocarcinoma University of Colorado, Denver Recruiting No outcome recorded
Phase 1 NCT05296005 Dec 2025 gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Ohio State University Comprehensive Cancer Center Withdrawn No outcome recorded
Phase 1 NCT07059299 Dec 2025 → Aug 2027 expected esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Recruiting No outcome recorded
Phase 1 NCT06913218 Jul 2025 → Feb 2028 expected pancreatic ductal adenocarcinoma Akeso Not yet recruiting No outcome recorded
Phase 1 NCT06859762 Jul 2025 → Jul 2028 expected neoplasm MediLink Therapeutics (Suzhou) Co., Ltd. Recruiting No outcome recorded
Phase 1/259 trials · 1 met primary · 2 missed
Phase 1/2 NCT07805551 Aug 2026 → Aug 2030 expected colorectal cancer Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT07522411 Apr 2026 → Dec 2027 expected hepatocellular carcinoma BinYong Liang Not yet recruiting No outcome recorded
Phase 1/2 NCT07595172 Apr 2026 → Aug 2028 expected pancreatic ductal adenocarcinoma West China Hospital Recruiting No outcome recorded
Phase 1/2 NCT07282184 Oct 2025 → Jun 2027 expected hepatocellular carcinoma Tongji Hospital Recruiting No outcome recorded
Phase 1/2 NCT06780111 Jul 2025 → Jan 2032 expected esophageal squamous cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT06731803 Mar 2025 → Dec 2027 expected gastroesophageal adenocarcinoma Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Active not recruiting No outcome recorded
Phase 1/2 NCT06741020 Mar 2025 → Jun 2026 overdue hepatocellular carcinoma Zhejiang Cancer Hospital Recruiting No outcome recorded
Phase 1/2 NCT06736717 Feb 2025 → Jul 2026 overdue malignant pancreatic neoplasm University of Kansas Medical Center Active not recruiting No outcome recorded
Phase 1/2 NCT06409637 Jan 2025 → Dec 2027 expected hepatocellular carcinoma Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 1/2 NCT06572813 Nov 2024 → Sep 2026 overdue malignant pancreatic neoplasm Zhejiang University Recruiting No outcome recorded
Phase 2442 trials · 13 met primary · 14 missed
Phase 2 NCT07814417 Oct 2026 → Nov 2028 expected colorectal neoplasm Eli Lilly and Company Not yet recruiting No outcome recorded
Phase 2 NCT07815288 Sep 2026 → Dec 2029 expected colorectal adenocarcinoma Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07817888 Sep 2026 → Sep 2028 expected — Sixth Affiliated Hospital, Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07833241 Sep 2026 → Sep 2028 expected pancreatic exocrine neoplasm Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07827053 Sep 2026 → Sep 2029 expected pancreatic ductal adenocarcinoma Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT07603375 Sep 2026 → Aug 2029 expected esophageal adenocarcinoma Duke University Recruiting No outcome recorded
Phase 2 NCT07810114 Aug 2026 → Dec 2027 expected rectal cancer Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07809893 Aug 2026 → Dec 2027 expected colorectal cancer Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07290985 Jul 2026 → Jun 2028 expected gastroesophageal adenocarcinoma American Association for Cancer Research Recruiting No outcome recorded
Phase 2 NCT07841574 Jun 2026 → Jun 2028 expected intrahepatic cholangiocarcinoma Lianghe Lu Recruiting No outcome recorded
Show all 442 trials opens the full record — a long page
Phase 2/324 trials · 4 met primary · 8 missed
Phase 2/3 NCT06028737 Mar 2025 → Apr 2027 expected gastric adenocarcinoma, gastroesophageal cancer, gastroesophageal junction adenocarcinoma Ukrainian Society of Clinical Oncology Recruiting No outcome recorded
Phase 2/3 NCT06279130 Jan 2024 → Jan 2029 expected — The Netherlands Cancer Institute Recruiting No outcome recorded
Phase 2/3 NCT05610163 Dec 2022 → Jul 2030 expected rectum adenocarcinoma Alliance for Clinical Trials in Oncology Active not recruiting No outcome recorded
Phase 2/3 NCT05171166 Dec 2021 → Oct 2025 hepatocellular carcinoma Peking University Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT04068103 Dec 2019 → Jun 2023 overdue colon adenocarcinoma NRG Oncology Active not recruiting Missed primary
Phase 2/3 NCT04393584 Jan 2019 → Jan 2024 gastric neoplasm Blokhin's Russian Cancer Research Center Unknown No outcome recorded
Phase 2/3 NCT03771560 Feb → Jun 2018 autism spectrum disorder University of California, San Francisco Completed No outcome recorded
Phase 2/3 NCT02758951 Jun 2017 → Oct 2024 overdue colorectal adenocarcinoma, peritoneal carcinoma, peritoneal carcinomatosis Koen Rovers Active not recruiting Missed primary
Phase 2/3 NCT03081143 May 2017 → May 2026 gastroesophageal cancer Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Completed Missed primary
Phase 2/3 NCT02591030 Dec 2015 → Jun 2018 bile duct cancer University Hospital of Saint-Etienne Completed Missed primary
Phase 3131 trials · 16 met primary · 22 missed
Phase 3 NCT06783491 May 2026 → Jun 2030 expected colorectal carcinoma Maimónides Biomedical Research Institute of Córdoba Recruiting No outcome recorded
Phase 3 NCT07472868 Mar 2026 → Mar 2030 expected rectal carcinoma J. W. A. Burger Not yet recruiting No outcome recorded
Phase 3 NCT07004413 Jan 2026 → Jan 2028 expected colorectal cancer Charite University, Berlin, Germany Not yet recruiting No outcome recorded
Phase 3 NCT07277842 Dec 2025 → Dec 2028 expected rectum adenocarcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 3 NCT07118800 Dec 2025 → Dec 2030 expected rectum adenocarcinoma UNICANCER Not yet recruiting No outcome recorded
Phase 3 NCT06346197 Dec 2025 → May 2028 expected gastric cancer, metastatic malignant neoplasm Centre Leon Berard Recruiting No outcome recorded
Phase 3 NCT07188025 Oct 2025 → Oct 2030 expected rectal cancer Erasmus Medical Center Recruiting No outcome recorded
Phase 3 NCT07155629 Sep 2025 → Aug 2030 expected pancreas disorder Helsinki University Central Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06813976 Jul 2025 → Jul 2033 expected ampulla of vater adenocarcinoma Centre Hospitalier Universitaire Dijon Recruiting No outcome recorded
Phase 3 NCT06501482 Jun 2025 → Jun 2028 expected metastasis from malignant tumor of colon Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Show all 131 trials opens the full record — a long page
Phase 47 trials
Phase 4 NCT07790445 Jul 2026 → Dec 2028 expected biliary tract cancer Zhai Wenlong Recruiting No outcome recorded
Phase 4 NCT06311916 May 2024 → Dec 2027 expected hepatocellular carcinoma Chen Xiaoping Not yet recruiting No outcome recorded
Phase 4 NCT06010277 Feb 2023 → Jan 2024 mesothelioma, non-small cell lung carcinoma, thymoma Amphia Hospital Unknown No outcome recorded
Phase 4 NCT05203172 Jul 2022 → Jul 2029 expected cancer Pfizer Recruiting No outcome recorded
Phase 4 NCT02284529 Oct 2012 → Aug 2014 colorectal cancer Sinphar Pharmaceutical Co., Ltd Completed No outcome recorded
Phase 4 NCT01023633 Oct 2009 → Jan 2014 colorectal cancer Nanjing Medical University Unknown No outcome recorded
Phase 4 NCT00559676 Mar 2005 → May 2011 colorectal cancer Centre Hospital Regional Universitaire de Limoges Completed No outcome recorded
Phase not applicable22 trials · 1 met primary · 2 missed
— NCT07618546 May 2026 → Mar 2027 expected hepatocellular carcinoma Henan Cancer Hospital Not yet recruiting No outcome recorded
— NCT07283939 Feb 2026 → May 2030 expected appendix carcinoma, cancer of unknown primary site, carcinoma of esophagus, carcinoma of the ampulla of vater +3 Alliance for Clinical Trials in Oncology Recruiting No outcome recorded
— NCT06893887 May 2025 → Dec 2027 expected hepatocellular carcinoma Nanjing Tianyinshan Hospital Recruiting No outcome recorded
— NCT06519578 Aug 2024 → Jul 2026 overdue hepatocellular carcinoma RenJi Hospital Recruiting No outcome recorded
— NCT05832398 May 2023 → Jan 2025 colorectal cancer Nanfang Hospital, Southern Medical University Unknown No outcome recorded
— NCT05644249 Dec 2022 → Jun 2025 gastric cancer, peritoneal carcinomatosis Vilnius University Completed No outcome recorded
— NCT04521491 Dec 2020 → Dec 2022 hepatocellular carcinoma Eastern Hepatobiliary Surgery Hospital Unknown No outcome recorded
— NCT03904043 Jul 2020 → Aug 2024 rectum adenocarcinoma Washington University School of Medicine Completed No outcome recorded
— NCT03217097 Oct 2018 → Jan 2022 neuroendocrine neoplasm Hospices Civils de Lyon Completed Missed primary
— NCT02813096 Oct 2016 → Jul 2018 hepatocellular carcinoma Guangxi Medical University Unknown No outcome recorded
Phase not stated2 trials · 1 met primary
— NCT00786058 — malignant pancreatic neoplasm CONKO-Studiengruppe Approved for marketing Met primary
— NCT02436044 — hepatic vascular disorder, hepatocellular carcinoma Ming Zhao Approved for marketing No outcome recorded
Comparator or background therapy1,056 trials
Phase 0 NCT07328087 Background Feb 2026 → Dec 2030 expected colorectal cancer Biogenea Pharmaceuticals Ltd. Recruiting No outcome recorded
Phase 0 NCT06011772 Background Dec 2023 → Feb 2026 overdue colorectal cancer Roswell Park Cancer Institute Active not recruiting No outcome recorded
Phase 0 NCT05108428 Background Dec 2021 → Oct 2023 overdue rectum adenocarcinoma H. Lee Moffitt Cancer Center and Research Institute Active not recruiting No outcome recorded
Phase 0 NCT03684980 Background Nov 2018 → Nov 2027 expected central nervous system non-hodgkin lymphoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 0 NCT03515941 Background Jun 2018 → Mar 2020 digestive system cancer Tannaz Armaghany Terminated No outcome recorded
Show all 1,056 trials opens the full record — a long page

Press releases naming this drug 8 releases

DateIssuerRelease
2025-11-17 PharmaEngine ONIVYDE® with oxaliplatin, fluorouracil and leucovorin will be included in Taiwan NHI for first-line treatment of metastatic pancreatic adenocarcinoma pharmaengine.com ↗
2025-09-22 GlaxoSmithKline GSK to submit label update for Wellcovorin (leucovorin) at US FDA’s request gsk.com ↗
2021-11-25 Ono Pharmaceutical Co., Ltd. ONO Receives Approval of Opdivo® (nivolumab) for Expanded Use for Two Indications in Japan - First-line Treatment of Unresectable Advanced or Recurrent Gastric Cancer in Combination with Chemotherapy - Adjuvant Treatment of Esophageal Cancer PDF(192 KB) @media screen and (max-width: 767px){ .mod__table-data { min-width: 100px !important; } } Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; “ONO”) and Bristol-Myers Squibb K.K. (Shinjuku, Tokyo; President, Jean-Christophe Barland) today announced that ONO has received the approvals of Opdivo® (generic name: nivolumab) Intravenous Infusion (“Opdivo”), a human anti-PD-1 monoclonal antibody in Japan, for expanded use for the first-line treatment of unresectable advanced or recurrent gastric cancer in combination with chemotherapy, and adjuvant treatment of esophageal cancer, for a partial change in approved items of the manufacturing and marketing approval. 〈Approval for the first-line treatment of unresectable advanced or recurrent gastric cancer〉 This approval is based on the results from the following 2 clinical studies: CheckMate -649 study (ONO-4538-44): A global multi-center, randomized, open-label Phase 3 clinical study, evaluating Opdivo plus chemotherapy or Opdivo plus Yervoy (ipilimumab) combination compared to chemotherapy alone in patients with previously untreated, non-human epidermal growth factor receptor 2 (non-HER2)-positive, unresectable advanced or recurrent gastric cancer (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (ESA), conducted on a world-wide basis including Japan, South Korea and Taiwan In this study, Opdivo plus chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival (OS) both in all randomized patient population and OS in PD-L1 positive patients with a combined positive score (CPS) ≥5, one of the primary endpoints, versus chemotherapy. Furthermore, Opdivo plus chemotherapy demonstrated a statistically significant extension in progression-free survival (PFS) in PD-L1 positive patients with CPS ≥5, the other primary endpoint, versus chemotherapy. The safety profile of Opdivo plus chemotherapy in the study was consistent with the known safety profiles of the individual treatments. ATTRACTION-4 study (ONO-4538-37): A multi-center, randomized Phase 2/3 clinical study, evaluating Opdivo plus chemotherapy compared to placebo plus chemotherapy in patients with previously untreated, HER-2 negative, unresectable advanced or recurrent GC or GEJC, conducted in Japan, South Korea and Taiwan In this study, Opdivo plus chemotherapy showed a statistically significant extension in PFS, one of the primary endpoints, versus placebo plus chemotherapy. On the other hand, Opdivo plus chemotherapy did not demonstrate a statistically significance in OS, the other of the primary endpoints. The safety profile of Opdivo plus chemotherapy in the study was consistent with the known safety profiles of the individual treatments. About CheckMate -649 study (ONO-4538-44) Checkmate -649 is a multi-center, randomized, open-label Phase 3 clinical study, evaluating Opdivo plus chemotherapy or Opdivo plus Yervoy combination compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, unresectable advanced or recurrent gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. Patients in the Opdivo plus chemotherapy arm received Opdivo 240 mg plus fluorouracil, calcium folinate and oxaliplatin (FOLFOX) every two weeks or Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks. Patients in the chemotherapy arm received FOLFOX or CapeOX every two or three weeks, respectively. All patients continued treatment up to two years or until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoints of the study are overall survival (OS) in PD-L1 positive patients with a combined positive score (CPS) ≥ 5 treated with Opdivo plus chemotherapy and progression-free survival (PFS) in CPS ≥ 5 patients treated with Opdivo plus chemotherapy. Key secondary endpoint is OS in CPS ≥ 1 and all-randomized patients treated with Opdivo plus chemotherapy. About ATTRACTION-4 study (ONO-4538-37) ATTRACTION-4 study is a multi-center, randomized Phase 2/3 clinical study, evaluating Opdivo plus chemotherapy (oxaliplatin + S-1 or capecitabine) compared to placebo plus chemotherapy in patients with previously untreated, HER2 negative unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer. Patients received Opdivo 360 mg or placebo every 3 weeks until disease progression or unacceptable toxicity is observed. The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS). About Gastric cancer It is estimated that about 138,000 new cases 1) are diagnosed with gastric cancer per year in Japan (about 1,089,000 cases worldwide 2) ) and approximately 46,000 deaths 1) (about 768,000 worldwide 2) ) per year resulting from this disease 1) , which is the 2nd most common type of cancer after lung cancer in Japan. As there has been little progression in the standard of care of first-line chemotherapy for the HER2 negative unresectable, advanced or recurrent gastric cancer in the past decade in Japan, an innovative treatment option is needed in this patient population. Globocan 2020: Stomach Cancer, Japan, World Health Organization https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf Globocan 2020: Stomach Cancer, World, World Health Organization https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf 〈Approval for the adjuvant treatment of esophageal cancer〉 This approval is based on the results from a global multi-center, randomized, double-blind Phase 3 clinical study, CheckMate -577 study (ONO-4538-43), evaluating Opdivo monotherapy as an adjuvant treatment in patients with resected esophageal cancer (ESC) or gastroesophageal junction cancer (GEJC) compared to placebo. In this study, Opdivo showed a statistically significant improvement in disease-free survival (DFS), the primary endpoint of the study, compared to placebo. The safety profile of Opdivo in this study was consistent with previously reported studies of Opdivo monotherapy. About CheckMate -577 study (ONO-4538-43) CheckMate -577 study is a global multi-center, randomized, double-blind Phase 3 clinical study, evaluating Opdivo monotherapy as an adjuvant treatment in patients with resected esophageal cancer or gastroesophageal junction cancer (GEJC) who have received chemoradiation therapy (CRT) and have not achieved a pathological complete response. Following neoadjuvant CRT and complete tumor surgical resection (also known as trimodality therapy), patients were randomized to receive Opdivo or placebo. In patients receiving Opdivo, it was administered at 240 mg every two weeks for 16 weeks followed by Opdivo 480 mg every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent, with a maximum of one year total treatment duration. The primary endpoint of the study is disease-free survival (DFS) and the secondary endpoint is overall survival (OS). About esophageal cancer Esophageal cancer is a malignant tumor that occurs in the inner layer (mucosa) of the esophagus and grows outside (toward the deeper layer). There are two main histological types of esophageal cancer; squamous cell carcinoma (SCC) and adenocarcinoma. SCC is the predominant type accounting for about 90% of all esophageal cancer in Japan. It is estimated that about 26,000 new cases1) are diagnosed with esophageal cancer per year in Japan (about 604,000 cases worldwide 2) ) and approximately 12,000 deaths 1) (about 544,000 worldwide 2) ) per year resulting from this disease. In Japan, radical resection following neoadjuvant therapy is performed as a treatment for resectable locally advanced esophageal cancer that does not have distant metastasis, but recurrence has been observed in 28-47% after radical resection. Furthermore, since the prognosis of recurrent cases after radical resection of esophageal cancer is extremely poor 3) , it is considered that there is a high medical need for postoperative adjuvant therapy aimed at suppressing recurrence. Globocan 2020: Esophageal Cancer, Japan, World Health Organization Available at: https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf Globocan 2020: Esophageal Cancer, World, World Health Organization Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf Guideline for Diagnosis and Treatment of Carcinoma of the Esophagus 2017, The Japan Esophageal Society Overview of Opdivo® Intravenous Infusion Product name Opdivo® Intravenous Infusion 20mg, 100mg, 120mg and 240mg Generic name (JAN) Nivolumab (Genetical recombination) Indication Melanoma Unresectable, advanced or recurrent non-small cell lung cancer Unresectable or metastatic renal cell carcinoma Recurrent or refractory classical Hodgkin lymphoma Recurrent or metastatic head and neck cancer Unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy Unresectable advanced or recurrent malignant pleural mesothelioma Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed after chemotherapy Unresectable advanced or recurrent esophageal cancer that has progressed after chemotherapy Adjuvant treatment of esophageal cancer Dosage and administration 〈Melanoma〉 Usually, for adults, administer at 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In the adjuvant treatment of melanoma, the administration period does not exceed 12 months. In combination therapy with ipilimumab for unresectable melanoma, usually, for adults, administer 80 mg of nivolumab every 3 weeks for 4 doses. After that, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. 〈Unresectable, advanced or recurrent non-small cell lung cancer , and unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy 〉 Usually, for adults, administer at 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In combination therapy with other anti-tumor drugs, usually, for adults, administer 240 mg of nivolumab every 2 weeks or 360 mg every 3 weeks as intravenous infusion. 〈Unresectable or metastatic renal cell carcinoma〉 Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In combination with cabozantinib, usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In combination therapy with ipilimumab for unresectable or metastatic renal cell carcinoma previously untreated with chemotherapy, usually, for adults, administer 240 mg of nivolumab as intravenous infusion every 3 weeks for 4 doses. After that, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. 〈Recurrent or refractory classical Hodgkin lymphoma〉 Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. Usually for pediatrics, administer 3 mg/kg (body weight) of nivolumab every 2 weeks as intravenous infusion. For pediatrics weighing 40 kg (body weight) or more, nivolumab can be administered at 240 mg of every 2 weeks or 480 mg every 4 weeks as intravenous infusion. 〈Recurrent or metastatic head and neck cancer〉 Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. 〈Unresectable advanced or recurrent malignant pleural mesothelioma〉 Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In combination therapy with ipilimumab, usually, for adults, administer 240 mg of nivolumab every 2 weeks or 360 mg every 3 weeks as intravenous infusion. 〈Microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed after chemotherapy〉 Usually, for adults, administer at 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In combination therapy with ipilimumab, usually, for adults, administer 240 mg of nivolumab as intravenous infusion every 3 weeks for 4 doses. After that, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. 〈Unresectable advanced or recurrent esophageal cancer that has progressed after chemotherapy, and adjuvant treatment of esophageal cancer〉 Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. In the adjuvant treatment of esophageal cancer, the administration period does not exceed 12 months. 〈 Recurrent or metastatic head and neck cancer, unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy, and unresectable advanced or recurrent esophageal cancer that has progressed after chemotherapy〉 Usually, for adults, administer 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks as intravenous infusion. Manufacturer/distributor Ono Pharmaceutical Co., Ltd. Co-promotion Bristol-Myers Squibb K.K. Note: Underlined parts show the revised ones according to this approval. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in Japan in July 2014. Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, China, the US and European Union. In Japan, ONO launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable, advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell carcinoma in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma which has progressed after chemotherapy in August 2018, and microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020. In addition, ONO has submitted supplemental applications for the adjuvant treatment of urothelial cancer and cancer of unknown primary, and is conducting clinical development program including hepatocellular carcinoma, ovarian cancer, bladder cancer, prostate cancer, pancreatic cancer, biliary tract cancer, etc. About the ONO and Bristol-Myers Squibb Collaboration In 2011, through a collaboration agreement with Bristol-Myers Squibb (BMS), ONO granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where ONO had retained all rights to Opdivo except the US at the time. In July 2014, ONO and BMS further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agent and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. Back to List ono-pharma.com ↗
2017-10-18 XBiotech, Inc. XBiotech Announces First Patient in Study Evaluating MABp1 in Combination with OnivydeⓇ and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer xbiotech.com ↗
2017-09-20 XBiotech, Inc. XBiotech Announces Agreement with Cedars-Sinai Medical Center to Evaluate MABp1 in Combination with OnivydeⓇ and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer xbiotech.com ↗
2016-10-18 Takeda Shire Granted EU Marketing Authorization of ONIVYDE®, In Combination With 5-Fluorouracil (5-FU) And Leucovorin (LV), For The Treatment of Metastatic Adenocarcinoma Of The Pancreas in Adult Patients Who Have Progressed Following Gemcitabine-Based Therapy takeda.com ↗
2012-07-06 Bristol-Myers Squibb FDA Approves ERBITUX(R) (cetuximab) as First-Line Treatment in KRAS Mutation-Negative (Wild-Type) Epidermal Growth Factor Receptor (EGFR)-Expressing Metastatic Colorectal Cancer in Combination with FOLFIRI (Irinotecan, 5-Fluorouracil, Leucovorin) bms.com ↗
2012-07-06 Eli Lilly and Company FDA Approves ERBITUX(R) (cetuximab) as First-Line Treatment in KRAS Mutation-Negative (Wild-Type) Epidermal Growth Factor Receptor (EGFR)-Expressing Metastatic Colorectal Cancer in Combination with FOLFIRI (Irinotecan, 5-Fluorouracil, Leucovorin) lilly.com ↗

Evidence & citations 41 cited values

Every value below carries the sentence it was read from. 1,825 sources stand behind the page.

FieldValueCited text
Known as Leucovorin “Adjuvant chemotherapy: FOLFOX6 regiment : Oxaliplatin(Hengrui Medicine Co., Ltd,China) 85mg/m2 IV d1, Leucovorin (Hengrui Medicine Co., Ltd,China)400mg/m2 IV d1, 5-FU(Hengrui...” NCT01889303 ↗
1314

“Cetuximab 500mg/m² + envafolimab 200mg + irinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to...” NCT05959356 ↗

“Patients will be randomized to receive 5 cycles of combination chemotherapy (5-FU, adriamycin, leucovorin, cytoxan, G-CSF) either as initial therapy (preoperative) or...” NCT00001250 ↗

“Oxaliplatin 85 mg/m2 intravenously on day 1; Leucovorin 200 mg/m2 IV(in vein) from hour 0 to 2 on days 1 and 2; and Fluorouracil 400 mg/m2 IV bolus at hour 2, then 600mg/m2...” NCT02527772 ↗

“It will comprise irinotecan, 180 mg/m2 IV infusion over 30 to 120 minutes; leucovorin, 400 mg/m2 IV infusion to match the duration of the irinotecan infusion; and 5-FU, 400...” NCT01124630 ↗

“Randomization to receive 400 mg sorafenib twice daily (sorafenib group) or 400 mg sorafenib twice daily plus HAIC (SoraHAIC group) (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2,...” PMID 31070690 ↗ Jul 2019

“The FOLFOXIRI chemotherapy regimen (5-fluorouracil, leucovorin, oxaliplatin, irinotecan) will be administered according to the study protocol as part of total neoadjuvant...” NCT07277842 ↗

“Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV...” NCT04084496 ↗

“The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the...” NCT03042780 ↗

“This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab...” NCT00671372 ↗

“The mFOLFOX regimen was administered via hepatic artery: oxaliplatin , 85mg/m2 , from hour 0 to 2 on day1 ; leucovorin , 400mg/m2 , from hour 2 to 3 on day 1 ; fluorouracil ,...” NCT05007587 ↗

Show 1,304 more sources

Known as 5-formyl tetrahydrofolic acid “folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion” NCT05004350 ↗
Known as 5-formyltetrahydrofolate ClinicalTrials.gov intervention name — accepted as the source's own label NCT00877227 ↗
Known as Ca-folinate “Leucovorin (Ca-folinate) (200 mg/m2)” NCT02578368 ↗
Known as calcium folinate “folinic acid (also called leucovorin, calcium folinate or FA) fluorouracil (also called 5FU) irinotecan given per institutional standard (intravenously day 1 and day 15 of 28 day cycle)” NCT04587128 ↗
7

“Folinic acid calcium salt (calcium folinate) is the bioactive metabolite of folic acid that does not require reduction by dihydrofolate reductase (DHFR).” NCT04723134 ↗

“Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.” NCT07702032 ↗

“oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)” NCT02658214 ↗

“Leucovorin 400 mg/m² (or Calcium Folinate 200 mg/m²), IV, over 120 min, D1” NCT06959693 ↗

“Drug: Leucovorin (Calcium Folinate)” NCT02720068 ↗

“Drug: Leucovorin (Calcium Folinate)” NCT07621718 ↗

“Drug: Leucovorin (Calcium Folinate)” NCT07775287 ↗

Known as calcium leucovorin “5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab” NCT06643793 ↗
1

“calcium leucovorin (20 mg/m\^2) IV bolus, on Days 1, 8, 15” NCT02620800 ↗

Known as calcium levofolinate “* Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine [calcium levofolinate]) (IV/2 hours), via a Y connector at the same time as irinotecan” NCT02591030 ↗
1

“Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.” NCT05988814 ↗

Known as Citrovorum Factor “5-Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590.” NCT00425152 ↗
1

“Leucovorin calcium, Citrovorum Factor, CF, NSC-3590” NCT00002471 ↗

Known as D/L-folinic acid “folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid)” NCT01289821 ↗
Known as dl-leucovorin “leucovorin \[dl-leucovorin\] 400 mg/m\^2 i.v. infusion over 90 minutes” NCT01085331 ↗
1

“dl leucovorin\* 400 mg/m² IV infusion over 2 hours” NCT02173990 ↗

Known as DL-LV “dextro-levogyre (DL-LV) racemic mixture 400 mg/m²” NCT03982121 ↗
Known as Elvorin “folinic acid 200 mg/m² (or Elvorin 400 mg/m²) IV during 2h” NCT04188145 ↗
Known as Elvorine “Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours” NCT02352337 ↗
4

“* Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine [calcium levofolinate]) (IV/2 hours), via a Y connector at the same time as irinotecan” NCT02591030 ↗

“Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours” NCT02827201 ↗

“* Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) by 2-hours IV infusion,” NCT03959293 ↗

“Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) IV over 2 hours” NCT03186326 ↗

Known as EPIC with FUDR and Leucovorin ClinicalTrials.gov intervention name — accepted as the source's own label NCT01815359 ↗
Known as FOL “FOLFOX (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and oxaliplatin \[OX\]) was supplied as solutions for intravenous administration.” NCT00959647 ↗
2

“mFOLFOX6 is combination of folinic acid (FOL)/leucovorin, 5-fluorouracil and oxaliplatin (OX) which acts as systemic cytotoxic agent.” NCT03250832 ↗

“Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX)” NCT00551213 ↗

Known as folinic acid “Irinotecan will be administered intravenously at a dose of 180 mg/m\^2 along with folinic acid administration intravenously at a dose of 400 mg/m\^2 (racemic) or 200 mg/m\^2...” NCT00778830 ↗
312

“Patients received either fluorouracil plus folinic acid (folinic acid, 20 mg/m(2), intravenous bolus injection, followed by fluorouracil, 425 mg/m(2) intravenous bolus...” PMID 20823433 ↗ Sep 2010

“Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour...” NCT06846346 ↗

“mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes,...” NCT03099265 ↗

“This phase II trial included patients with clinical T1-T3abN0 low- or mid-rectal adenocarcinoma eligible for endoscopic resection who were treated with 3 months of chemotherapy...” PMID 35981270 ↗ Aug 2022

“The trial TyRosine kinase Inhibitor for the treatment of Chemorefractory Colorectal Cancer (TRICC-C) trial evaluates the addition of nintedanib to mFOLFOX6 (fluorouracil,...” PMID 32930387 ↗ Oct 2020

“This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant)...” NCT06780787 ↗

“This multicenter phase II non-comparative trial evaluated the addition of aflibercept to infusional 5-fluorouracil/folinic acid (LV5FU2 regimen) as first-line treatment in...” PMID 38672597 ↗ Apr 2024

“The regimen tested consisted of bevacizumab (5 mg/kg), folinic acid(400 mg/m²), 5-fluorouracil (2400 mg/m² for 46 h), oxaliplatin (85 mg/m²) and irinotecan (70 mg/m²...” PMID 39913183 ↗ Feb 2025

“D29 and D43 FOLFIRINOX: Oxaliplatin 85mg / m², Irinotecan 180mg / m², Folinic acid 400 mg / m², 5-fluorouracil 400mg / m² in bolus followed by continuous administration over...” NCT05065801 ↗

“oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2...” NCT02226380 ↗

Show 302 more sources

Known as folinic acid (FA) “folinic acid (FA)” NCT04617457 ↗
Known as Folinic acid (FA, i.e. Leucovorin, Wyeth) “Folinic acid (FA, i.e. Leucovorin®, Wyeth)” NCT00153998 ↗
Known as Folinic acid (leucovorin) “Folinic acid (leucovorin)” NCT01571024 ↗
1

“Folinic Acid (Leucovorin)” NCT02568046 ↗

Known as Folinic acid calcium salt “Folinic acid calcium salt (calcium folinate) is the bioactive metabolite of folic acid that does not require reduction by dihydrofolate reductase (DHFR).” NCT04723134 ↗
Known as L-folinic acid “Oxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour...” NCT06846346 ↗
4

“folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid)” NCT01289821 ↗

“folinic acid 400mg/m2 (or L-folinic acid 200 mg/m2) over 2h” NCT07118800 ↗

“folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²)” NCT07359456 ↗

“folinic acid 400 mg/m² IV (or L-folinic acid 200 mg/m²)” NCT07437287 ↗

Known as l-leucovorin “Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer” NCT00209625 ↗
1

“L-Leucovorin 200 mg/sqm iv over 2 hours, day 1” NCT02904031 ↗

Known as l-LV “Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer” NCT00209625 ↗
6

“Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15” NCT02102789 ↗

“Leucovorin (l-LV) 200mg/m2 ivd over 2 hours on Day 1” NCT03493048 ↗

“Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1” NCT04084496 ↗

“Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1” NCT04224402 ↗

“Leucovorin (LV) levogyre form (LLV) 200 mg/m²” NCT03982121 ↗

“Leucovorin(l-LV) 400 mg/m2 IV over 2 hours” NCT06153368 ↗

Known as LCV “To study the safety and effectiveness of trimetrexate (TMTX) plus leucovorin calcium rescue (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have...” NCT00000724 ↗
7

“To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia...” NCT00000998 ↗

“This study compares therapy with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus high-dose steroids (methylprednisolone).” NCT00000730 ↗

“TMTX, in combination with leucovorin (LCV), did not cause severe toxicity in a preliminary trial.” NCT00001013 ↗

“Leucovorin (LCV) IV or PO begins 6 hours after MTX has been completed over 6 hours for 8 doses” NCT00000723 ↗

“investigational drug therapy (trimetrexate plus leucovorin calcium (TMTX / LCV))” NCT00000714 ↗

“investigational drug trimetrexate (TMTX) with leucovorin rescue (LCV)” NCT00001016 ↗

“LCV, 400 mg/m2 administered over 2 hours concurrent with oxaliplatin” NCT05378867 ↗

Known as leucovorin (Folina tab, TTY Biopharm, TW) “leucovorin (Folina tab, TTY Biopharm, TW)” NCT04999332 ↗