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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT04088500
Collaborator
(none)
5
Enrollment
12
Locations
1
Arm
14.4
Actual Duration (Months)
0.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Biological: Nivolumab
  • Biological: Ipilimumab
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
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
Actual Study Start Date :
Sep 3, 2020
Actual Primary Completion Date :
Nov 15, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab + Ipilimumab (combination)

Nivolumab + Ipilimumab (combination) Q3W for 4 doses

Biological: Nivolumab
Specific dose on specific days
Other Names:
  • Opdivo

    • Biological: Ipilimumab
    Specific dose on specific days

    Outcome Measures

    Primary Outcome Measures

    1. Disease Control Rate (DCR) [6 months after 1st treatment]

    Secondary Outcome Measures

    1. Overall Survival (OS) [1st dose to specific time frame]

    2. Objective Rate Response Rate (ORR) [24 months]

    3. Duration of Response (DOR) [24 months]

    4. Time to objective Response (TTR) [24 months]

    5. Progression- free survival rate (PFSR) [24 months]

    6. Incidence of adverse events (AEs) [from first dose and up to 100 days following the last dose of study treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine in St. Louis WUSTL Saint Louis Missouri United States 63110-1002
    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
    5 Atlantic Clinical Cancer Research Unit Halifax Nova Scotia Canada B3H 1V7
    6 Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC) Hamilton Ontario Canada L8V 5C2
    7 Toronto Sunnybrook Regional Cancer Ctr Toronto Ontario Canada M4N 3M5
    8 Local Institution Toronto Ontario Canada M5G 2M9
    9 Local Institution Montreal Quebec Canada H2X 3E4
    10 Local Institution - 0005 Montreal Quebec Canada H3T 1E2
    11 Local Institution Quebec City Quebec Canada G2L 2Z3
    12 Local Institution - 0006 Sherbrooke Quebec Canada J1H 5N4

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04088500
    Other Study ID Numbers:
    • CA209-73M
    First Posted:
    Sep 12, 2019
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Jun 23, 2022