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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)

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ClinicalTrials.gov Identifier: NCT03668119
Recruitment Status : Active, not recruiting
First Posted : September 12, 2018
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Pan Tumor Biological: Nivolumab Biological: Ipilimumab Phase 2

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Study Type : Interventional  (Clinical Trial)
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 31, 2018
Actual Primary Completion Date : May 3, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


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




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

Secondary Outcome Measures :
  1. BICR-assessed ORR in participants treated with nivolumab monotherapy [ Time Frame: Approximately 3 years ]
  2. Investigator-assessed ORR in participants treated with nivolumab combined with ipilimumab and nivolumab monotherapy [ Time Frame: Approximately 3 years ]
  3. Duration of response (DOR) [ Time Frame: Approximately 3 years ]
  4. Time To Response (TTR) [ Time Frame: Approximately 3 years ]
  5. Clinical benefit rate (CBR) [ Time Frame: Approximately 3 years ]
  6. BICR assessed Progression Free Survival (PFS) [ Time Frame: Approximately 3 years ]
  7. Investigator assessed PFS [ Time Frame: Approximately 3 years ]
  8. Overall survival (OS) [ Time Frame: Approximately 3 years ]
  9. Number of participants with Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
  10. Number of participants with clinical laboratory abnormalities [ Time Frame: Approximately 3 years ]


Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668119


Locations
Show Show 60 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03668119    
Other Study ID Numbers: CA209-848
2016-002898-35 ( EudraCT Number )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action