RecruitingPhase 1Phase 2NCT03539822

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)


Sponsor

Anwaar Saeed

Enrollment

117 participants

Start Date

Oct 22, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of drugs — cabozantinib (a targeted therapy), durvalumab (an immunotherapy), and possibly tremelimumab (another immunotherapy) — in patients with advanced stomach, esophageal, colorectal, or liver cancer. **You may be eligible if...** - You are 18 years or older in reasonably good health (ECOG score 0–1) - You have been diagnosed with advanced or locally unresectable gastric, esophageal, colorectal, or liver cancer - Your cancer can be measured on scans - You are willing to have a tumor biopsy before treatment starts - For stomach and esophageal cancers: you have already tried at least one standard therapy and it stopped working - For colorectal cancer: you have tried at least two prior standard therapies - For liver cancer: you have tried at least one prior therapy (depending on the study group) **You may NOT be eligible if...** - Your cancer has not been treated with the required number of prior therapies - You are unwilling or unable to have a tumor biopsy - Your overall health is too poor for this treatment combination Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabozantinib

by mouth

DRUGDurvalumab

infusion

DRUGTremelimumab

infusion


Locations(2)

University of Kansas Cancer Center

Westwood, Kansas, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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NCT03539822


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