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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03668119
Ethics application status
Date submitted
11/09/2018
Date registered
12/09/2018

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
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab

Experimental: Nivolumab + Ipilimumab Combination -

Experimental: Nivolumab Monotherapy -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Other: Ipilimumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A
Timepoint [1] 0 0
From date of randomization up to 42 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B
Timepoint [1] 0 0
From date of randomization up to 57 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) Per Investigator
Timepoint [2] 0 0
From date of randomization up to 57 months
Secondary outcome [3] 0 0
Duration of Response (DoR) Per Investigator
Timepoint [3] 0 0
From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Secondary outcome [4] 0 0
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Timepoint [4] 0 0
From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Secondary outcome [5] 0 0
Time to Objective Response (TTR) Per Investigator
Timepoint [5] 0 0
From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)
Secondary outcome [6] 0 0
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
Timepoint [6] 0 0
From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)
Secondary outcome [7] 0 0
Clinical Benefit Rate (CBR) Per Investigator
Timepoint [7] 0 0
From date of randomization up to 57 months
Secondary outcome [8] 0 0
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
Timepoint [8] 0 0
From date of randomization up to 57 months
Secondary outcome [9] 0 0
Progression Free Survival (PFS) Per Investigator
Timepoint [9] 0 0
From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Secondary outcome [10] 0 0
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Timepoint [10] 0 0
From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Secondary outcome [11] 0 0
Overall Survival (OS)
Timepoint [11] 0 0
From date of randomization to date of death (Up to 57 months)
Secondary outcome [12] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [12] 0 0
From first dose to 30 days post last dose (Up to 25 months)
Secondary outcome [13] 0 0
Number of Participants With On-Treatment Laboratory Parameters
Timepoint [13] 0 0
From first dose to 30 days post last dose (Up to 25 months)

Eligibility
Key inclusion criteria
* Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with high tumor mutational burden (TMB-H) who are refractory to standard local therapies, or for which no standard treatment is available.
* Must be able to provide tissue and blood TMB-H testing results
* Must have measurable disease for response assessment
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (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 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2023
Sample size
Target
Accrual to date
Final
212
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - 0118 - St Leonards
Recruitment hospital [2] 0 0
Local Institution - 0062 - Sydney
Recruitment hospital [3] 0 0
Local Institution - 0117 - Woolloongabba
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Caba
Country [10] 0 0
Argentina
State/province [10] 0 0
Cordoba
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Metropolitana
Country [18] 0 0
Denmark
State/province [18] 0 0
Copenhagen
Country [19] 0 0
Denmark
State/province [19] 0 0
Herlev
Country [20] 0 0
France
State/province [20] 0 0
Lyon Cedex 08
Country [21] 0 0
France
State/province [21] 0 0
Marseille Cedex 9
Country [22] 0 0
France
State/province [22] 0 0
Paris Cedex 5
Country [23] 0 0
France
State/province [23] 0 0
Toulouse
Country [24] 0 0
France
State/province [24] 0 0
Villejuif
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Bonn
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Essen
Country [29] 0 0
Germany
State/province [29] 0 0
Wuerzburg
Country [30] 0 0
Italy
State/province [30] 0 0
Genova
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Napoli
Country [33] 0 0
Italy
State/province [33] 0 0
Siena
Country [34] 0 0
Netherlands
State/province [34] 0 0
Zuid-Holland
Country [35] 0 0
Netherlands
State/province [35] 0 0
Amsterdam
Country [36] 0 0
Poland
State/province [36] 0 0
Mazowieckie
Country [37] 0 0
Poland
State/province [37] 0 0
Gdansk
Country [38] 0 0
Puerto Rico
State/province [38] 0 0
San Juan
Country [39] 0 0
Romania
State/province [39] 0 0
Cluj
Country [40] 0 0
Romania
State/province [40] 0 0
Bucuresti
Country [41] 0 0
Romania
State/province [41] 0 0
Craiova
Country [42] 0 0
Romania
State/province [42] 0 0
Floresti
Country [43] 0 0
Romania
State/province [43] 0 0
Timisoara, Timis
Country [44] 0 0
Singapore
State/province [44] 0 0
Central Singapore
Country [45] 0 0
Singapore
State/province [45] 0 0
Singapore
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Pamplona
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Greater London
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Preston

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03668119