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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Clinical Trials of Interest

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

  • Clinicaltrials.gov identifier

    NCT04088500

  • Recruitment Status

    Recruiting

  • 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

N/A

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

Criteria

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

Contacts

Locations

United States, Missouri
Local Institution
Saint Louis

United States, Ohio
Local Institution
Columbus

United States, Utah
Local Institution
Salt Lake City

United States, Washington
Local Institution
Seattle

Canada, Alberta
Local Institution
Calgary

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver

Canada, Nova Scotia
Local Institution
Halifax

Canada, Ontario
Local Institution
Hamilton

Canada, Ontario
Local Institution
Ottawa

Canada, Ontario
Local Institution
Toronto

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
CHUM
Montreal

Canada, Quebec
Sir Mortimer B Davis Jewish General Hospital
Montreal

Canada, Quebec
Local Institution
Quebec City

Canada, Quebec
CIUSSS de lEstrie-CHUS
Sherbrooke

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov 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