Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
NCT03539822 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 117
Last updated 2026-01-21
Summary
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.
Conditions
- Gastric Cancer
- Esophageal Adenocarcinoma
- Hepatocellular Carcinoma
- Colorectal Cancer
Interventions
- DRUG
-
by mouth
- DRUG
-
infusion
- DRUG
-
Tremelimumab
infusion
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
Anwaar Saeed
lead OTHER
Principal Investigators
-
Anwaar Saeed, MD · University of Pittsburgh
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-22
- Primary Completion
- 2028-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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