NCT03539822

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

A Phase I/II Trial of Cabozantinib in Combination With Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Gastroesophageal Cancer and Other Gastrointestinal (GI) Malignancies (CAMILLA)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Anwaar Saeed · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Cabozantinib	by mouth
DRUG	Durvalumab	infusion
DRUG	Tremelimumab	infusion

Timeline

• Start date: 2018-10-22
• Primary completion: 2028-06-30
• Completion: 2029-06-30
• First posted: 2018-05-29
• Last updated: 2026-01-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study