Description:
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab
combined with ipilimumab.
Title
- Brief Title: A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
- Official Title: A Phase 2, Single-arm Open-label Study of Combination Nivolumab and Ipilimumab Retreatment in Advanced Renal Cell Carcinoma Patients Progressing on Nivolumab Maintenance Therapy After Nivolumab and Ipilimumab Induction
Clinical Trial IDs
- ORG STUDY ID:
CA209-73M
- NCT ID:
NCT04088500
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo | Nivolumab + Ipilimumab (combination) |
Ipilimumab | | Nivolumab + Ipilimumab (combination) |
Purpose
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab
combined with ipilimumab.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab + Ipilimumab (combination) | Experimental | Nivolumab + Ipilimumab (combination) Q3W for 4 doses | |
Eligibility Criteria
Inclusion Criteria:
-Participants and Target Disease Characteristics- -
- Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after
induction with ipilimumab and nivolumab
- Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be
submitted for embedded tissue block or tumor tissue.
Age and Reproduction Sexually active males with WOCBP must agree to instructions for
contraception and fetal protection.
WOCBP need to use contraception throughout the study and for 5 months post treatment.
Exclusion Criteria autoimmune disease statement
- Active central nervous system metastases
- Participants with an active autoimmune disease, diabetes mellitus, skin disorders,
hyperthyroidism requiring hormone treatments are permitted to enroll.
- Any major surgery 28 days before 1st treatment Concomitant Therapy
- participants that have received a live vaccine within 30 days of treatment.
- use of investigational agent or device with in 28 days before first dosage study
treatment.
Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and
Reproduction
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease Control Rate (DCR) |
Time Frame: | 6 months after 1st treatment |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | 1st dose to specific time frame |
Safety Issue: | |
Description: | |
Measure: | Objective Rate Response Rate (ORR) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to objective Response (TTR) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Progression- free survival rate (PFSR) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events (AEs) |
Time Frame: | from first dose and up to 100 days following the last dose of study treatment |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 26, 2020