Cabozantinib in Combination With Durvalumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies (CAMILLA)
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|ClinicalTrials.gov Identifier: NCT03539822|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : November 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Esophageal Adenocarcinoma Hepatocellular Carcinoma Colorectal Cancer||Drug: Cabozantinib Drug: Durvalumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase II has 3 disease cohorts, 29 patients each|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Cabozantinib in Combination With Durvalumab (MEDI4736) in Patients With Advanced Gastroesophageal Cancer and Other Gastrointestinal (GI) Malignancies (CAMILLA)|
|Actual Study Start Date :||September 14, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Cabozantinib combined with Durvalumab
*Flat dose of 1500mg intravenous (IV) Infusion on day 1 of every 28 day cycle
Other Name: multi-tyrosine kinase Inhibitor
Other Name: anti-Programmed cell death protein 1 (PD-L1) inhibitor
- Phase I- Maximum Tolerated Dose (MTD) [ Time Frame: 9 months ]Defined as the highest dose studied for which the observed incidence of dose limiting toxicities (DLT) is less than 33%. Determined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Phase II- Overall Response Rate (ORR) [ Time Frame: Every 8 weeks for 12 months ]Defined as the proportion of participants best response to treatment.
- Proportion of participants with adverse events (AEs). [ Time Frame: 18 months ]Determined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Overall Benefit Rate (OBR) [ Time Frame: 18 months ]Defined as the proportion of patients with overall benefit to therapy. Overall benefit is defined as the best response recorded, (including complete Response (CR), Partial Response (PR), and Stable Disease (SD)), from the start of the treatment until the end of treatment. Determined per Modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Progression Free Survival (PFS) [ Time Frame: 24 months ]Defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first. Determined per Modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Overall Survival (OS) [ Time Frame: 24 months ]Defined as the time from the start of treatment until death due to any cause. Determined per Modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539822
|Contact: KUCC Navigator||913-588-3671||KUCC_Navigation@kumc.edu|
|Contact: Anwaar Saeed, MDfirstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Cancer Center||Recruiting|
|Westwood, Kansas, United States, 66205|
|Contact: KUCC Navigator 913-588-3671 KUCC_Navigation@kumc.edu|
|Principal Investigator:||Anwaar Saeed, MD||The University of Kansas Cancer Center|