A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma

Stopped early · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.

Key facts

Study ID

NCT04088500

Run by

Bristol-Myers Squibb

People needed

5

Starts

2020-09-03

Expected to finish

2021-11-15

Last updated by the study team

2023-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Washington University School of Medicine in St. Louis WUSTL — St Louis, Missouri, United States
• Local Institution — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• BC Cancer Agency - Vancouver Centre — Vancouver, British Columbia, Canada
• Atlantic Clinical Cancer Research Unit — Halifax, Nova Scotia, Canada
• Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC) — Hamilton, Ontario, Canada
• Toronto Sunnybrook Regional Cancer Ctr — Toronto, Ontario, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Montreal, Quebec, Canada
• Local Institution - 0005 — Montreal, Quebec, Canada
• Local Institution — Québec, Quebec, Canada
• Local Institution - 0006 — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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