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

  • identifier


  • Recruitment Status


  • First Posted

    September 12, 2019

  • Last update posted

    August 26, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Renal Cell Carcinoma
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Ipilimumab
  • Phase: Phase 2

Detailed Description


Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Estimated Study Start Date: September 2020
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: July 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab (combination)
Nivolumab + Ipilimumab (combination) Q3W for 4 doses
Biological: Nivolumab
Specific dose on specific days

Biological: Ipilimumab
Specific dose on specific days

Outcome Measures

  • Primary Outcome Measures: 1. Disease Control Rate (DCR) [ Time Frame: 6 months after 1st treatment ]
  • Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: 1st dose to specific time frame ]
  • 2. Objective Rate Response Rate (ORR) [ Time Frame: 24 months ]
  • 3. Duration of Response (DOR) [ Time Frame: 24 months ]
  • 4. Time to objective Response (TTR) [ Time Frame: 24 months ]
  • 5. Progression- free survival rate (PFSR) [ Time Frame: 24 months ]
  • 6. Incidence of adverse events (AEs) [ Time Frame: from first dose and up to 100 days following the last dose of study treatment ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: 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. - 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

Contacts and Locations



United States, Missouri
Local Institution
Saint Louis

United States, Ohio
Local Institution

United States, Utah
Local Institution
Salt Lake City

United States, Washington
Local Institution

Canada, Alberta
Local Institution

Canada, Alberta
Cross Cancer Institute

Canada, British Columbia
BC Cancer Agency - Vancouver Centre

Canada, Nova Scotia
Local Institution

Canada, Ontario
Local Institution

Canada, Ontario
Local Institution

Canada, Ontario
Local Institution

Canada, Ontario
Local Institution

Canada, Quebec

Canada, Quebec
Sir Mortimer B Davis Jewish General Hospital

Canada, Quebec
Local Institution
Quebec City

Canada, Quebec
CIUSSS de lEstrie-CHUS

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • Identifier: NCT04088500 History of Changes
  • Other Study ID Numbers: CA209-73M
  • First Posted: September 12, 2019 Key Record Dates
  • Last Update Posted: August 26, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma, Renal Cell Carcinoma