Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Anwaar Saeed
You may qualify if…
- ✓ 1. Age ≥ 18 years
- ✓ 2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- ✓ 3. Histologically confirmed diagnosis of any of the following:
- ✓ Gastric or gastroesophageal junction adenocarcinoma
- ✓ Esophageal adenocarcinoma
- ✓ Colorectal adenocarcinoma (CRC)
- ✓ Hepatocellular carcinoma (HCC)
- ✓ 4. Patients should have advanced (stage 4) or locally unresectable (stage III) disease.
You may not qualify if…
- ✕ 1. 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).
- ✕ 2. 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.
- ✕ 3. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.
- ✕ \* Evidence of tumor invading the GI tract, (Defined as T4 primary tumor in patients with gastric, gastroesophageal and esophageal adenocarcinoma and CRC).
- ✕ \* Gastric or esophageal varices that are untreated or incompletely treated with bleeding or high risk for bleeding. Subjects treated with adequate endoscopic therapy (according to institutional standards) without any episodes of recurrent GI bleeding requiring transfusion or hospitalization for at least 6 months prior to study entry are eligible.
- ✕ 4. Evidence of active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
- ✕ 5. Inability to swallow tablets.
- ✕ 6. Uncontrollable ascites or pleural effusion.
Where it's recruiting
Westwood
Pittsburgh
Source: ClinicalTrials.gov · NCT03539822 · last updated 2026-01-21