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)

Anwaar Saeed

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 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. 5. Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 6. Patients must consent to undergo a required screening/baseline bio…

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)

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

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