Therapy Detail
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| Therapy Name | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin |
| Synonyms | Nivolumab + FOLFOX |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov). |
| Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
| Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (FDA.gov). |
| Oxaliplatin | Eloxatin | Diaminocyclohexane Oxalatoplatinum | Chemotherapy - Platinum 7 | Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05111626 | Phase I | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Bemarituzumab + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer. (FORTITUDE-102) | Recruiting | USA | ROU | POL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 10 |
| NCT03921684 | Phase II | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Capecitabine | Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients | Recruiting | ISR | 0 |
| NCT06253611 | Phase II | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin EXL01 + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS >=5 Metastatic Gastric Cancer (BIG) | Recruiting | FRA | 0 |
| NCT03662659 | Phase II | Nivolumab + Relatlimab + Tegafur-gimeracil-oteracil Potassium Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin + Relatlimab Nivolumab + Tegafur-gimeracil-oteracil Potassium Capecitabine + Nivolumab + Oxaliplatin Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Capecitabine + Nivolumab + Oxaliplatin + Relatlimab | An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers | Completed | USA | POL | NOR | ITA | GBR | FRA | ESP | DEU | CZE | CAN | BEL | AUT | AUS | ARG | 3 |
| NCT06346197 | Phase III | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Capecitabine + Nivolumab + Oxaliplatin Balstilimab + Botensilimab | Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas (CIME) | Not yet recruiting | FRA | 0 |
| NCT05568095 | Phase III | AB154 + Fluorouracil + Leucovorin + Oxaliplatin + Zimberelimab AB154 + Capecitabine + Oxaliplatin + Zimberelimab Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Capecitabine + Nivolumab + Oxaliplatin | A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body (STAR-221) | Active, not recruiting | USA | TUR | ROU | POL | LTU | ITA | ISR | HUN | GRC | GBR | FRA | ESP | CAN | BRA | AUS | ARG | 13 |
| NCT03547999 | Phase II | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin CV301 + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC | Active, not recruiting | USA | 0 |
| NCT05476796 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Nivolumab + Oxaliplatin + Trifluridine-tipiracil hydrochloride Oxaliplatin + Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer (LOGICAN) | Recruiting | FRA | 0 |
| NCT05677490 | Phase III | Fluorouracil + Irinotecan + Leucovorin + Nivolumab + Oxaliplatin Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma | Recruiting | USA | 1 |
| NCT04021108 | Phase II | Nivolumab Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L) | Active, not recruiting | USA | 0 |
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