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 147 PD-L1/PD-1 antibody 117 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
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 7
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) Recruiting USA | ITA | GBR | FRA | ESP | CAN | AUS 23
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
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
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
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 18
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
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


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