drugset / Trial / NCT03539822

Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies

NCT03539822

Phase 1/2 Recruiting 117 enrolled Anwaar Saeed AstraZeneca · collabExelixis · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-10-22
Primary completion
2028-06-30
Completion
2029-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabozantinib Small molecule 40 mg Oral
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Tremelimumab Monoclonal antibody 300 mg Intravenous