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

December 15, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 3L1
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency - Vancouver Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Atlantic Clinical Cancer Research Unit
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC)
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Ctr
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Local Institution
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0005
      • Quebec City, Quebec, Canada, G2L 2Z3
        • Local Institution
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0006
  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine in St. Louis WUSTL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: From first dose up to approximately 14 months

Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
From first dose up to approximately 14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From first dose to the date of death from any cause (up to approximately 14 months)
Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact ("last known alive date"). OS will be censored for participants at the date of first dose if they were treated but had no follow-up.
From first dose to the date of death from any cause (up to approximately 14 months)
Overall Response Rate (ORR)
Time Frame: From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months)

Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months)
Duration of Response (DOR)
Time Frame: From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)

Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Progression Free Survival (PFS)
Time Frame: From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Time to Objective Response (TTR)
Time Frame: From first dose to the first confirmed documented response (up to approximately 14 months)

Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the first confirmed documented response (up to approximately 14 months)
The Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose and 100 days after lost dose (up to approximately 14 months)
The number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose and 100 days after lost dose (up to approximately 14 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2020

Primary Completion (Actual)

November 15, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-73M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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