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CheckMate 848: 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)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03668119
Collaborator
(none)
212
Enrollment
60
Locations
2
Arms
60
Anticipated Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

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

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 :
Oct 31, 2018
Actual Primary Completion Date :
May 3, 2022
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab + Ipilimumab Combination

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

    • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy
  • BMS-734016

    		•
    Experimental: Nivolumab Monotherapy

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blinded independent central review (BICR)-assessed Objective Response Rate (ORR) in participants treated with nivolumab combined with ipilimumab [Approximately 3 years]

    Secondary Outcome Measures

    1. BICR-assessed ORR in participants treated with nivolumab monotherapy [Approximately 3 years]

    2. Investigator-assessed ORR in participants treated with nivolumab combined with ipilimumab and nivolumab monotherapy [Approximately 3 years]

    3. Duration of response (DOR) [Approximately 3 years]

    4. Time To Response (TTR) [Approximately 3 years]

    5. Clinical benefit rate (CBR) [Approximately 3 years]

    6. BICR assessed Progression Free Survival (PFS) [Approximately 3 years]

    7. Investigator assessed PFS [Approximately 3 years]

    8. Overall survival (OS) [Approximately 3 years]

    9. Number of participants with Adverse Events (AEs) [Approximately 3 years]

    10. Number of participants with clinical laboratory abnormalities [Approximately 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Wayne Cancer Center Santa Monica California United States 90404
    2 Rocky Mountain Cancer Centers Denver Colorado United States 80218
    3 Local Institution - 0093 Minneapolis Minnesota United States 55404
    4 Broome Oncology Johnson City New York United States 13790
    5 Duke Cancer Institute Durham North Carolina United States 27710
    6 Local Institution - 0079 Portland Oregon United States 97239
    7 Local Institution - 0095 Austin Texas United States 78731
    8 Local Institution - 0094 Dallas Texas United States 75231
    9 Local Institution - 0090 Houston Texas United States 77030
    10 Texas Oncology - Northeast Texas Tyler Texas United States 75702
    11 Local Institution - 0016 Ciudad Autonoma Beunos Aires Buenos Aires Argentina 1431
    12 Local Institution - 0087 Ciudad Autónoma de Buenos Aires Buenos Aires Argentina 1280
    13 Local Institution - 0078 Caba Argentina 1199
    14 Local Institution - 0015 Caba Argentina 1426
    15 Local Institution - 0119 Cordoba Argentina 5000
    16 Local Institution - 0118 St Leonards New South Wales Australia 2065
    17 Local Institution - 0062 Sydney New South Wales Australia 2010
    18 Local Institution - 0117 Woolloongabba Queensland Australia 4102
    19 Local Institution - 0112 Brussels Belgium 1090
    20 Local Institution - 0113 Bruxelles Belgium 1200
    21 Local Institution - 0114 Leuven Belgium 3000
    22 Local Institution - 0010 Edmonton Alberta Canada T6G 1Z2
    23 Local Institution - 0060 Hamilton Ontario Canada L8V 5C2
    24 Local Institution - 0036 Montreal Quebec Canada H2X 3E4
    25 Local Institution - 0088 Montreal Quebec Canada H3T 1E2
    26 Local Institution - 0018 Santiago Metropolitana Chile 8330024
    27 Local Institution - 0082 Santiago Metropolitana Chile 8420383
    28 Local Institution - 0080 Copenhagen Denmark 2100
    29 Local Institution - 0081 Herlev Denmark 2730
    30 Local Institution - 0072 Lyon Cedex 08 France 69373
    31 Local Institution - 0075 Marseille Cedex 9 France 13273
    32 Local Institution - 0073 Paris Cedex 5 France 75248
    33 Local Institution - 0074 Toulouse France 31100
    34 Local Institution - 0085 Villejuif France 94805
    35 Local Institution - 0039 Berlin Germany 12200
    36 Local Institution - 0001 Bonn Germany 53127
    37 Local Institution - 0002 Dresden Germany 01307
    38 Local Institution - 0086 Essen Germany 45147
    39 Local Institution - 0043 Wuerzburg Germany 97080
    40 Local Institution - 0032 Genova Italy 16132
    41 Local Institution - 0030 Milano Italy 20133
    42 Local Institution - 0029 Napoli Italy 80131
    43 Local Institution - 0031 Siena Italy 53100
    44 Local Institution - 0115 Amsterdam Netherlands 1066 CX
    45 Local Institution - 0116 Rotterdam Netherlands 3015 GD
    46 Local Institution - 0076 Warszawa Mazowieckie Poland 02-781
    47 Local Institution - 0077 Gdansk Poland 80-214
    48 Fundacion De Investigacion San Juan Puerto Rico 00927
    49 Local Institution - 0068 Cluj-Napoca Cluj Romania 400015
    50 Local Institution - 0069 Bucuresti Romania 022328
    51 Local Institution - 0067 Craiova Romania 200347
    52 Local Institution - 0070 Floresti Romania 407280
    53 Local Institution - 0071 Timisoara, Timis Romania 300239
    54 Local Institution - 0066 Singapore Singapore 117599
    55 Local Institution - 0065 Singapore Singapore 169610
    56 Local Institution - 0084 Barcelona Spain 08035
    57 Local Institution - 0083 Madrid Spain 28041
    58 Local Institution - 0110 Pamplona Spain 31008
    59 Local Institution - 0106 London Greater London United Kingdom W12 OHS
    60 Local Institution - 0107 Preston United Kingdom PR2 9HT

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03668119
    Other Study ID Numbers:
    • CA209-848
    • 2016-002898-35
    First Posted:
    Sep 12, 2018
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Jul 28, 2022