Status:
TERMINATED
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04088500
Start Date
September 3 2020
End Date
November 15 2021
Last Update
January 10 2023
Active Locations (12)
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1
Washington University School of Medicine in St. Louis WUSTL
St Louis, Missouri, United States, 63108
2
Local Institution
Calgary, Alberta, Canada, T3B 3L1
3
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
4
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6