Drug intelligence / Profile preview

placebo + oxaliplatin + capecitabine + fluorouracil + nivolumab

Development stage
Unknown
Lead developer
Bristol Myers Squibb
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

The combination of **placebo + oxaliplatin + capecitabine + fluorouracil + nivolumab** is a multi-agent therapeutic regimen used as a control arm in Phase 3 clinical trials for advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma. This regimen represents the current standard-of-care backbone, consisting of the immune checkpoint inhibitor **nivolumab** (a PD-1 inhibitor) and a platinum-based chemotherapy doublet (typically **oxaliplatin** plus either **capecitabine** or **fluorouracil**), with the addition of a **placebo** to maintain blinding in trials evaluating novel investigational agents. Nivolumab enhances anti-tumor immune responses by blocking the PD-1/PD-L1 pathway, while the chemotherapy components induce tumor cell death through DNA damage (oxaliplatin) and inhibition of thymidylate synthase (fluorouracil and its prodrug capecitabine). This specific combination is notably utilized as the comparator arm in trials such as TST001-3001 (evaluating osemitamab) and FORTITUDE-102 (evaluating bemarituzumab).

Other names
placebo + oxaliplatin + capecitabine + 5-fluorouracil + NIVOPlacebo + Nivolumab + ChemotherapyPlacebo + Nivo + Chemo
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)DNATS (Thymidylate synthase)

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