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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03668119




Registration number
NCT03668119
Ethics application status
Date submitted
11/09/2018
Date registered
12/09/2018
Date last updated
30/06/2020

Titles & IDs
Public title
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)
Scientific 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)
Secondary ID [1] 0 0
2016-002898-35
Secondary ID [2] 0 0
CA209-848
Universal Trial Number (UTN)
Trial acronym
CheckMate 848
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pan Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab

Experimental: Nivolumab + Ipilimumab Combination -

Experimental: Nivolumab Monotherapy -


Other interventions: Nivolumab
Specified dose on specified days

Other interventions: Ipilimumab
Specified dose on specified days

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) in the Tissue Tumor Mutational Burden (tTMB-H) Population
Timepoint [1] 0 0
Approximately 3 years
Primary outcome [2] 0 0
Objective Response Rate (ORR) in the Blood Tumor Mutational Burden (bTMB-H) Population
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Duration of response (DOR)
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Time To Response (TTR)
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Clinical benefit rate (CBR)
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Progression Free Survival (PFS)
Timepoint [6] 0 0
Approximately 3 years
Secondary outcome [7] 0 0
Incidence of Adverse Events (AEs)
Timepoint [7] 0 0
Approximately 3 years
Secondary outcome [8] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [8] 0 0
Approximately 3 years
Secondary outcome [9] 0 0
Incidence of AEs leading to discontinuation
Timepoint [9] 0 0
Approximately 3 Years
Secondary outcome [10] 0 0
Incidence of Deaths
Timepoint [10] 0 0
Approximately 3 Years
Secondary outcome [11] 0 0
Incidence of laboratory abnormalities
Timepoint [11] 0 0
Approximately 3 years
Secondary outcome [12] 0 0
Incidence of anti-drug antibody (ADA)
Timepoint [12] 0 0
Approximately 3 years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- 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
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - St Leonards
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4012 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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Georgia
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Illinois
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Minnesota
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Missouri
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New York
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North Carolina
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United States of America
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Ohio
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Oregon
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United States of America
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Pennsylvania
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Tennessee
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Texas
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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RIO Negro
Country [19] 0 0
Argentina
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Caba
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Argentina
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Cordoba
Country [21] 0 0
Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Leuven
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Brazil
State/province [24] 0 0
RIO Grande DO SUL
Country [25] 0 0
Brazil
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SAO Paulo
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Brazil
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Sao Paulo
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Canada
State/province [27] 0 0
Alberta
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Montreal
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Chile
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Metropolitana
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Chile
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Valparaiso
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Denmark
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Copenhagen
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Denmark
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Herlev
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France
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Lyon Cedex 08
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France
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Marseille Cedex 9
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France
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Paris Cedex 5
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France
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Toulouse
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France
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Villejuif
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Essen
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Germany
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Heidelberg
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Germany
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Wuerzburg
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Siena
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Peru
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Lima
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Peru
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Arequipa
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Poland
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Mazowieckie
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Gdansk
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Floresti
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Romania
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Timisoara, Timis
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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United Kingdom
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Greater London
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United Kingdom
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London
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United Kingdom
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Preston
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT03668119
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03668119