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A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H) (CheckMate 848)

  • Clinicaltrials.gov identifier

    NCT03668119

  • Recruitment Status

    Active, not recruiting

  • First Posted

    September 12, 2018

  • Last update posted

    September 17, 2021

Study Description

Brief summary:

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)

  • Condition or Disease:Pan Tumor
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Ipilimumab
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 212 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: October 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab Combination
Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Nivolumab Monotherapy
Biological: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Objective Response Rate (ORR) in the Blood Tumor Mutational Burden (bTMB-H) Population [ Time Frame: Approximately 3 years ]
  • 2. Objective Response Rate (ORR) in the Tissue Tumor Mutational Burden (tTMB-H) Population [ Time Frame: Approximately 3 years ]
  • Secondary Outcome Measures: 1. Objective Response Rate (ORR) [ Time Frame: Approximately 3 years ]
  • 2. Time To Response (TTR) [ Time Frame: Approximately 3 years ]
  • 3. Clinical benefit rate (CBR) [ Time Frame: Approximately 3 years ]
  • 4. Overall survival (OS) [ Time Frame: Approximately 3 years ]
  • 5. Progression Free Survival (PFS) [ Time Frame: Approximately 3 years ]
  • 6. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
  • 7. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 3 years ]
  • 8. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 3 Years ]
  • 9. Incidence of Deaths [ Time Frame: Approximately 3 Years ]
  • 10. Incidence of laboratory abnormalities [ Time Frame: Approximately 3 years ]
  • 11. Incidence of anti-drug antibody (ADA) [ Time Frame: Approximately 3 years ]
  • 12. Duration of response (DOR) [ Time Frame: Approximately 3 years ]

Eligibility Criteria

  • Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with TMB-H who are refractory to standard local therapies, or for which no standard treatment is available. - Available tumor tissue and blood for TMB testing - Participants must have measurable disease for response assessment Exclusion Criteria: - Women with positive pregnancy test at enrollment or prior administration of study medication - Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease - Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Contacts

Locations

United States, California
John Wayne Cancer Center
Santa Monica

United States, Colorado
Rocky Mountain Cancer Centers
Denver

United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis

United States, New York
Broome Oncology
Johnson City

United States, North Carolina
Duke Cancer Institute
Durham

United States, Oregon
Oregon Health & Science University
Portland

United States, Texas
Texas Oncology, PA - Central Austin Cancer Center
Austin

United States, Texas
Texas Oncology
Dallas

United States, Texas
The University of Texas MD Anderson Cancer Center-merge
Houston

United States, Texas
Texas Oncology-Tyler
Tyler

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma Beunos Aires

Argentina, Buenos Aires
Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires

Argentina
Hospital Italiano De Buenos Aires
Caba

Argentina
Instituto Medico Especialazado Alexander Fleming
Caba

Argentina
Instituto Oncologico De Cordoba
Cordoba

Australia, New South Wales
The Kinghorn Cancer Centre
Darlinghurst

Australia, New South Wales
Royal North Shore Hospital
St Leonards

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Belgium
Local Institution
Brussels

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Leuven

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, Ontario
Juravinski Cancer Center At Hamilton Health Sciences
Hamilton

Canada, Quebec
Jewish General Hospital
Montreal

Canada
Local Institution
Montreal

Chile, Metropolitana
Local Institution
Santiago de Chile

Chile, Metropolitana
Clinica San Carlos de Apoquindo
Santiago

Denmark
Local Institution
Copenhagen

Denmark
Local Institution
Herlev

France
Centre Leon Berard
Lyon Cedex 08

France
Institut Paoli-Calmettes
Marseille Cedex 9

France
Institut Curie
Paris Cedex 5

France
Institut Claudius Regaud
Toulouse

France
Local Institution
Villejuif

Germany
Local Institution
Berlin

Germany
Universitaetsklinikum Bonn
Bonn

Germany
Universitaetsklinikum Carl Gustav Carus
Dresden

Germany
Universitatsklinik Essen
Essen

Germany
Univ. Klinikum Wuerzburg
Wuerzburg

Italy
Local Institution
Genova

Italy
IRCCS Istituto Nazionale Tumori Milano
Milano

Italy
Local Institution
Napoli

Italy
Azienda Ospedaliera Universitaria Senese
Siena

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Rotterdam

Poland, Mazowieckie
Oddzial Badan Wczesnych Faz
Warszawa

Poland
Klinika Onkologii i Radioterapii
Gdansk

Puerto Rico
Fundacion De Investigacion
San Juan

Romania
Local Institution
Bucuresti

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Romania
Local Institution
Floresti

Romania
Local Institution
Timisoara, Timis

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Spain
H. Univ. Vall dHebron
Barcelona

Spain
Local Institution
Madrid

Spain
Hosp Univer 12 De Octubre
Madrid

United Kingdom, Greater London
Local Institution
London

United Kingdom
Local Institution
Preston

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03668119 History of Changes
  • Other Study ID Numbers: CA209-848, 2016-002898-35
  • First Posted: September 12, 2018 Key Record Dates
  • Last Update Posted: September 17, 2021
  • Last Verified: September 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: TMB-H
  • Additional relevant MeSH terms: Neoplasms