trastuzumab + nivolumab + gemcitabine + cisplatin

The combination of trastuzumab, nivolumab, gemcitabine, and cisplatin is an investigational treatment regimen being studied primarily for HER2-positive biliary tract cancer (BTC) and other advanced cancers. Based on the search results, I can provide the following structured information about this combination therapy: ## Drug Information The canonical name for this drug combination is "trastuzumab + nivolumab + gemcitabine + cisplatin." This is a multi-drug regimen that combines targeted therapy (trastuzumab), immunotherapy (nivolumab), and chemotherapy agents (gemcitabine and cisplatin). This combination is being investigated in clinical trials, particularly for HER2-positive advanced biliary tract cancer in the HERBOT trial (NCT05749900), which is a multicenter, open-label, single-arm Phase Ib/II trial[1][4]. The regimen combines: - **Trastuzumab**: A HER2-targeted monoclonal antibody - **Nivolumab**: A PD-1 immune checkpoint inhibitor - **Gemcitabine and Cisplatin**: Traditional chemotherapy agents ## Mechanism of Action This combination approach leverages multiple mechanisms to target cancer: - **Trastuzumab** targets HER2-positive cancer cells by binding to the HER2 receptor, inhibiting tumor cell proliferation - **Nivolumab** blocks the PD-1 pathway, enhancing T-cell immune response against cancer cells - **Gemcitabine and Cisplatin** work as cytotoxic agents that interfere with DNA replication and repair ## Clinical Development The HERBOT trial is investigating this combination for HER2-positive advanced biliary tract cancer. According to the search results, the trial is in Phase Ib/II and was listed as "Not yet recruiting" as of the information available[1]. The dosing regimen in the trial includes: - Nivolumab 360mg IV every 3 weeks - Gemcitabine 1000mg/m² IV on Day 1 and Day 8 every 3 weeks - Cisplatin 25mg/m² IV on Day 1 and Day 8 every 3 weeks - Trastuzumab 8mg/kg (first cycle) then 6mg/kg IV every 3 weeks[1] ## Related Evidence Similar combinations have shown promise in other cancer types: - Nivolumab plus gemcitabine-cisplatin has demonstrated significantly better outcomes in patients with previously untreated advanced urothelial carcinoma compared to gemcitabine-cisplatin alone[5][7] - Trastuzumab combined with nivolumab and FOLFOX has shown promising efficacy in ERBB2-positive esophagogastric adenocarcinoma[8][10] - Trastuzumab deruxtecan plus nivolumab has demonstrated promising antitumor activity in HER2-expressing metastatic breast cancer and metastatic urothelial cancer[6] The rationale for this combination in HER2-positive biliary tract cancer is that the triple combination of nivolumab, trastuzumab, and cytotoxic chemotherapy may overcome innate resistance mechanisms and improve outcomes in this difficult-to-treat cancer type[1].

Other names

Nivolumab, Trastuzumab, Gemcitabine, and Cisplatin combinationHERBOT regimen