Therapy Detail
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| Therapy Name | Capecitabine + Nivolumab + Oxaliplatin |
| Synonyms | CapeOX + Nivolumab|CAPOX + Nivolumab |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Capecitabine | Xeloda | R340 | Chemotherapy - Antimetabolite 14 | Xeloda (capecitabine) is an antimetabolite that when activated to 5-FU ultimately inhibits DNA synthesis and cell division (NCI Drug Dictionary). |
| 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 |
|---|---|---|---|---|---|---|---|
| MSH6 negative | esophagus adenocarcinoma | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal adenocarcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MLH1 negative | stomach cancer | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic gastric cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | esophagus squamous cell carcinoma | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic esophagus squamous cell carcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MLH1 negative | esophagus adenocarcinoma | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal adenocarcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MLH1 negative | esophagus squamous cell carcinoma | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic esophagus squamous cell carcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | stomach cancer | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic gastric cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MLH1 negative | gastroesophageal junction adenocarcinoma | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic gastroesophageal junction adenocarcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | gastroesophageal junction adenocarcinoma | sensitive | Capecitabine + Nivolumab + Oxaliplatin | Guideline | Actionable | Opdivo (nivolumab), in combination with Xeloda (capecitabine) and Eloxatin (oxaliplatin) is included in guidelines as first-line therapy for patients with unresectable locally advanced, recurrent, or metastatic gastroesophageal junction adenocarcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
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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 |
| 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) | Recruiting | USA | ITA | GBR | FRA | ESP | CAN | AUS | 22 |
| NCT05859477 | Phase II | Capecitabine + Nivolumab + Oxaliplatin | Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer (NIVOFGFR2) | Recruiting | USA | 0 |
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