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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 12, 2018
Last Update Posted : March 16, 2023
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 |
| 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:
Biological: Ipilimumab Specified dose on specified days
Other Names:
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| Experimental: Nivolumab Monotherapy |
Biological: Nivolumab
Specified dose on specified days
Other Names:
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Primary Outcome Measures :
- 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 :
- BICR-assessed ORR in participants treated with nivolumab monotherapy [ Time Frame: Approximately 3 years ]
- Investigator-assessed ORR in participants treated with nivolumab combined with ipilimumab and nivolumab monotherapy [ Time Frame: Approximately 3 years ]
- Duration of response (DOR) [ Time Frame: Approximately 3 years ]
- Time To Response (TTR) [ Time Frame: Approximately 3 years ]
- Clinical benefit rate (CBR) [ Time Frame: Approximately 3 years ]
- BICR assessed Progression Free Survival (PFS) [ Time Frame: Approximately 3 years ]
- Investigator assessed PFS [ Time Frame: Approximately 3 years ]
- Overall survival (OS) [ Time Frame: Approximately 3 years ]
- Number of participants with Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
- Number of participants with clinical laboratory abnormalities [ Time Frame: Approximately 3 years ]
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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 60 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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: | March 16, 2023 |
| Last Verified: | March 2023 |
| 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:
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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 |