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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 : Recruiting
First Posted : September 12, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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)

Condition or disease Intervention/treatment Phase
Pan Tumor Biological: Nivolumab Biological: Ipilimumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 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 29, 2018
Estimated Primary Completion Date : March 14, 2021
Estimated Study Completion Date : September 8, 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. Objective Response Rate (ORR) [ Time Frame: Approximately 3 years ]
    Assessed by blinded independent central review (BICR)


Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: Approximately 3 years ]
    Assessed by BICR and investigator

  2. ORR [ Time Frame: Approximately 3 years ]
    Assessed by investigator

  3. TTR [ Time Frame: Approximately 3 years ]
    Assessed by BICR and investigator

  4. Clinical benefit rate (CBR) [ Time Frame: Approximately 3 years ]
    Assessed by BICR and investigator

  5. Overall survival (OS) [ Time Frame: Approximately 3 years ]
  6. PFS [ Time Frame: Approximately 3 years ]
    Assessed by BICR and investigator

  7. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
  8. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 3 years ]
  9. Incidence of laboratory abnormalities [ Time Frame: Approximately 3 years ]
  10. Incidence of anti-drug antibody (ADA) [ Time Frame: Approximately 3 years ]
    Measured by immunoassay



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

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

Inclusion Criteria:

  • 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

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-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


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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 100 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     History of Changes
Other Study ID Numbers: CA209-848
2016-002898-35 ( EudraCT Number )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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