Clinical Trials /

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

NCT04088500

Description:

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

Related Conditions:
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-73M
  • NCT ID: NCT04088500

Conditions

  • Renal Cell Carcinoma

Interventions

DrugSynonymsArms
NivolumabOpdivoNivolumab + Ipilimumab (combination)
IpilimumabNivolumab + Ipilimumab (combination)

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + Ipilimumab (combination)ExperimentalNivolumab + Ipilimumab (combination) Q3W for 4 doses
  • Nivolumab
  • Ipilimumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Control Rate (DCR)
Time Frame:6 months after 1st treatment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:1st dose to specific time frame
Safety Issue:
Description:
Measure:Objective Rate Response Rate (ORR)
Time Frame:24 months
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:24 months
Safety Issue:
Description:
Measure:Time to objective Response (TTR)
Time Frame:24 months
Safety Issue:
Description:
Measure:Progression- free survival rate (PFSR)
Time Frame:24 months
Safety Issue:
Description:
Measure:Incidence of adverse events (AEs)
Time Frame:from first dose and up to 100 days following the last dose of study treatment
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

June 17, 2020