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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    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