CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03628716|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : October 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Biological: CV301 Biological: Atezolizumab||Phase 2|
This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2). The trial will be performed using an optimal two-stage design within each cohort.
Stage 1, Cohort 1: Enroll 14 subjects. If objective response is not achieved in at least four patients, the cohort will be stopped for futility. If objective response is achieved in at least four subjects, the cohort will proceed to stage 2. If any patient is not evaluable for the primary endpoint, the patient may be replaced.
Stage 1, Cohort 2: Enroll 13 subjects. If objective response is not achieved in at least three patients, the cohort will be stopped for futility. If objective response is achieved in at least three subjects, the cohort will proceed to stage 2. If any patient is not evaluable for the primary endpoint, the patient may be replaced.
Stage 2, Cohort 1: Enroll an additional 19 subjects. If any patient is not evaluable for the primary endpoint, the patient may be replaced until a total of 33 patients are evaluable for the primary endpoint.
Stage 2, Cohort 2: Enroll an additional 22 subjects. If any patient is not evaluable for the primary endpoint, the patient may be replaced until a total of 35 patients are evaluable for the primary endpoint.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer|
|Actual Study Start Date :||September 18, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||November 2023|
Experimental: CV301 + Atezolizumab
Subject receiving combination treatment with CV301 + Atezolizumab
Prime with MVA-BN-CV301 (nominal titer 1.6 x 10^9 Inf.U) given subcutaneously (SC) on Day 1 and Day 22. One dose = four 0.5 mL injections. One injection = nominal titer 4 x 10^8 Inf.U in 0.5 mL.
Boost with FPV-CV301 (nominal titer of 1 × 10^9 Inf.U in 0.5 mL, given SC every 21 days for 4 doses (on days 43, 64, 85, and 106), followed by boosts every 6 weeks until 6 months on trial (i.e., days 148 and 190), then every 12 weeks until completion of 2 years. One dose = one 0.5 mL injection.
Atezolizumab fixed dose of 1200 mg intravenous on Day 1 of each 21-day cycle
- Objective Response Rate (ORR) [ Time Frame: up to 24 month ]The proportion of subjects with an ORR (complete (CR) or partial (PR) response) based on RECIST 1.1 evaluations as performed by the investigator
- Progression Free survival (PFS) [ Time Frame: at 6, 9 , 12, 18 and 24 months ]The time interval from first treatment to objective tumor progression or death
- Overall Survival (OS) [ Time Frame: 12, 18 and 24 months ]Time interval from first treatment to death of any cause
- Duration of Response [ Time Frame: up to 24 month ]The time from response (CR or PR, whichever comes first) to investigator assessed progression using RECIST 1.1 or death
- TEAEs [ Time Frame: up to 24 month ]Incidence of any Treatment-Emergent Adverse Events
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): NCT03628716
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute, Inc.|
|Tampa, Florida, United States, 33612|
|United States, Kentucky|
|Norton Cancer Institute, Norton Healthcare Pavilion|
|Louisville, Kentucky, United States, 40202|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute (DFCI)|
|Boston, Massachusetts, United States, 02215|
|United States, Utah|
|University of Utah - Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|