Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma (PemCab)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03534804|
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Urothelial Carcinoma Bladder Cancer||Drug: Cabozantinib Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open label, non-randomized phase 2 study|
|Masking:||None (Open Label)|
|Official Title:||Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma (PemCab)|
|Actual Study Start Date :||September 18, 2018|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
|Experimental: Cabozantinib and Pembrolizumab, all patients||
Cabozantinib is administered at 40 mg oral daily
Other Name: XL184
Pembrolizumab will be administered at a fixed dose of 200mg intravenously every 3 weeks.
- Overall Response Rate (ORR) [ Time Frame: 12 months ]To evaluate measurable disease overall response rate (ORR). Subjects will be evaluated by CT scans at regular intervals for disease assessment by RECISTv1.1 criteria for the duration of treatment
- Progression-free survival (PFS) at 6 months (PFS6) [ Time Frame: 6 months ]To evaluate progression-free survival (PFS) at 6 months (PFS6). Subjects will be evaluated by CT scans at regular intervals for disease assessment by RECISTv1.1 criteria for the duration of treatment.
- Overall Survival (OS) [ Time Frame: Patients are expected to stay on treatment for approximately 12 months; 18 months ]To evaluate Overall Survival (OS). Subjects will be evaluated using Kaplan-Meier estimation for survival for up to 6 months after discontinuation of study treatment; patients surviving longer than 6 months will be censored.
- Occurrence of Adverse Events and Serious Adverse Events [ Time Frame: 12 months ]To evaluate toxicities associate with the combination treatment. Adverse events will be collected beginning with study treatment and tabulated according to drug attribution.
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): NCT03534804
|Contact: Jill Broghammerfirstname.lastname@example.org|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Christine Ternival 813-745-2629 email@example.com|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Jill Broghammer 801-213-6232 firstname.lastname@example.org|
|Principal Investigator: Neeraj Agarwal, MD|