Phase Ib and Phase II Studies of MK-3475 in Combination + for Renal Cell Carcinoma:
|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: NCT02348008|
Recruitment Status : Active, not recruiting
First Posted : January 28, 2015
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Carcinoma||Drug: MK-3475 Drug: Bevacizumab||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib and Phase II Studies of Anti-PD-1 Antibody MK-3475 in Combination With Bevacizumab for the Treatment of Metastatic Renal Cell Carcinoma: Big Ten Cancer Research Consortium GU14-003|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Arm A - Phase 1b Dose Escalation Cohort
Cohort 1 will consist of 3-6 patients who will receive MK-3475 200mg and bevacizumab 10mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.
Cohort 2 will consist of 3-9 patients who will receive MK-3475 200mg and bevacizumab 15mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions.
If none of the 3 subjects experience a dose limiting toxicity (DLT) during the first cycle of therapy, an additional 3 subjects will be enrolled at dose level 2. If all three subjects in dose level 2 complete the first cycle of therapy without DLT, 3 more subjects will be enrolled to ensure only 0-1 of 6 subjects have a DLT. There will be no further escalation beyond dose level 2.
Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV
Other Name: Pembrolizumab
Arm A: Phase 1b Cohort 1: 10mg IV; Arm A: Phase 1b Cohort 2: 15mg IV
Other Name: Avastin
Arm B - Phase II Investigational Treatment
The maximum safe dose of MK-3475 in combination bevacizumab (as determined in the phase 1b cohort) will be given on day 1 of each 21 day cycle.
Arm B: Phase II Treatment: 200mg IV
Other Name: Pembrolizumab
Arm B: Phase II Treatment: administered at the maximum safe dose of 5mg or 10mg as established in the Phase 1b dose escalation cohort study.
Other Name: Avastin
- Phase 1b: Maximum Safe Dose of Treatment Regimen [ Time Frame: Every 21 days while on treatment (estimated 4 months) ]To establish the maximum tested safe dose of study drug MK-3475 and bevacizumab in combination for subjects with metastatic clear cell renal carcinoma after failure of at least one systemic therapy for metastatic disease.
- Phase II: Efficacy of Treatment Regimen [ Time Frame: Every 6 weeks while on treatment (estimated 10 months) ]To determine the activity of combination of MK-3475 and bevacizumab in first line therapy for subjects with treatment naïve metastatic clear cell RCC as assessed by response rates (complete or partial response) (RR) based on RECIST 1.1.
- Progression-Free Survival [ Time Frame: 6 months following end of treatment ]To determine progression-free survival (PFS) at 6 months for this patient population.
- Clinical Benefit Rate [ Time Frame: Every 6 months while on treatment (estimated 4-10 months) ]To determine the clinical benefit rate of treatment regimen (complete response, partial response, or stable disease) based on RECIST 1.1.
- Overall Survival [ Time Frame: Up to 2 years from registration ]To determine if treatment regimen improves overall survival for this patient population.
- Characterize Adverse Events [ Time Frame: Every week while on treatment (estimated 4-10 months) ]Toxicity will be assessed using CTCAE version 4.
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): NCT02348008
|United States, Illinois|
|Northwestern University, Robert H. Lurie Cancer Center|
|Chicago, Illinois, United States, 60611|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612|
|United States, Iowa|
|University of Iowa, Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Michigan State University, Breslin Cancer Center|
|Lansing, Michigan, United States, 48910|
|United States, Minnesota|
|University of Minnesota: Masonic Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Nebraska|
|University of Nebraska, Fred and Pamela Buffet Cancer Center|
|Omaha, Nebraska, United States, 68198|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Pennsylvania|
|Penn State Hershey Cancer Institute|
|Hershey, Pennsylvania, United States, 17033|
|Study Chair:||Arkadiusz Z Dudek, M.D., Ph.D.||Big Ten Cancer Research Consortium|