OncoMatch/Clinical Trials/NCT03539822
Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
Is NCT03539822 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Cabozantinib and Durvalumab for gastric cancer.
Treatment: Cabozantinib · Durvalumab · Tremelimumab — The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. The investigators believe that modulating the tumor microenvironment with biologic agents like cabozantinib will have synergistic effect when combined with checkpoint-based immunotherapeutics like durvalumab in this patient population. This is a phase I/II, open label, multi-cohort trial looking at safety, tolerability and efficacy endpoints.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Hepatocellular Carcinoma
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Required: NRAS wild-type
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
gastric, gastroesophageal, or esophageal adenocarcinoma must show evidence of progression or intolerance to at least one previous standard of care systemic therapy
Must have received: systemic therapy
CRC must show evidence of progression or intolerance to at least 2 previous standard of care systemic therapy
Must have received: EGFR monoclonal antibody (panitumumab, cetuximab)
Ras wild type patients should fail epidermal growth factor receptor (EGFR) monoclonal antibody (panitumumab or cetuximab) to be eligible
Must have received: systemic therapy
HCC must show evidence of disease progression or intolerance to at least 1 previous systemic regimen (not more than 2 lines of prior therapy)
Cannot have received: PD-1/PD-L1/PD-L2 inhibitor (durvalumab)
Exception: HCC and gastric / esophageal cancer patients with prior exposure to these agents are eligible
Prior treatment with a Programmed cell death protein 1 (PD1) or (PD-L1) inhibitor, including durvalumab, or anti PD-L2 (HCC and gastric / esophageal cancer patients with prior exposure to these agents are eligible)
Cannot have received: MET/HGF inhibitor (cabozantinib, crizotinib, foretinib, tivantinib, rilotumumab, onartuzumab)
Prior treatment with cabozantinib or other Receptor for hepatocyte growth factor (MET) or Dual MET/ Hepatocyte growth factor (HGF) monoclonal antibodies or MET/HGF tyrosine kinase inhibitors (TKIs), including crizotinib, foretinib, tivantinib, rilotumumab, and onartuzumab
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Kansas Cancer Center · Westwood, Kansas
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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