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
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 5
- Locations
- 9
- Primary Endpoint
- Disease Control Rate (DCR)
Overview
Brief Summary
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Disease Control Rate (DCR)
Time Frame: From first dose up to approximately 14 months
Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Secondary Outcomes
- Overall Survival (OS)(From first dose to the date of death from any cause (up to approximately 14 months))
- Overall Response Rate (ORR)(From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months))
- Duration of Response (DOR)(From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months))
- Time to Objective Response (TTR)(From first dose to the first confirmed documented response (up to approximately 14 months))
- Progression Free Survival (PFS)(From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months))
- The Number of Participants Experiencing Adverse Events (AEs)(From first dose and 100 days after lost dose (up to approximately 14 months))