Cabozantinib + Durvalumab +/- Tremelimumab for Gastrointestinal Cancers
(CAMILLA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, certain medications like immunosuppressive drugs and some anticoagulants are not allowed, so it's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination of Cabozantinib, Durvalumab, and Tremelimumab for gastrointestinal cancers?
Research shows that the combination of durvalumab and tremelimumab has been beneficial for patients with solid tumors, and in some studies, it improved survival in lung cancer. Durvalumab is also approved for certain bladder cancers, indicating its potential effectiveness in treating various cancers.12345
Is the combination of Cabozantinib, Durvalumab, and Tremelimumab safe for treating gastrointestinal cancers?
The combination of Cabozantinib and Durvalumab has shown a tolerable safety profile in patients with advanced gastrointestinal cancers, with no dose-limiting toxicities observed. However, when Durvalumab is combined with Tremelimumab, there is a higher incidence of severe side effects, such as reduced appetite and diarrhea, compared to Durvalumab alone.45678
How is the drug combination of Cabozantinib, Durvalumab, and Tremelimumab unique for gastrointestinal cancers?
This drug combination is unique because it combines Cabozantinib, which targets cancer cell growth, with Durvalumab and Tremelimumab, which are immune checkpoint inhibitors that help the immune system attack cancer cells. This approach is novel for gastrointestinal cancers, as it leverages both direct cancer cell inhibition and immune system activation.24579
What is the purpose of this trial?
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.
Research Team
Anwaar Saeed
Principal Investigator
University of Pittsburgh
Eligibility Criteria
Adults over 18 with certain advanced gastrointestinal cancers, including stomach and liver cancer, who have progressed after standard treatments or are intolerant to them. Participants must be able to swallow tablets, not have major organ dysfunction, agree to contraception if of childbearing potential, and not have a history of severe allergies or reactions to the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Cabozantinib and Durvalumab, with or without Tremelimumab, in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Cabozantinib
- Durvalumab
- Tremelimumab
Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Raed Al-Rajabi
Lead Sponsor
Anwaar Saeed
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD