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A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT04088500•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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

Locations (12)

Washington University School of Medicine in St. Louis WUSTL

St Louis, Missouri, United States

Local Institution

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Atlantic Clinical Cancer Research Unit

Halifax, Nova Scotia, Canada

Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC)

Hamilton, Ontario, Canada

Toronto Sunnybrook Regional Cancer Ctr

Toronto, Ontario, Canada

Local Institution

Toronto, Ontario, Canada

Local Institution

Montreal, Quebec, Canada

Local Institution - 0005

Montreal, Quebec, Canada

Key Dates

Start Date

September 3, 2020

Primary Completion Date

November 15, 2021

Completion Date

November 15, 2021

Last Updated

January 10, 2023

Enrollment

ACTUAL participants

Conditions

Renal Cell Carcinoma

Interventions

Nivolumab

BIOLOGICAL

Ipilimumab

BIOLOGICAL

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Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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RECRUITINGNA

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Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Cutaneous Melanoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma