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An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598960
Recruitment Status : Completed
First Posted : November 6, 2015
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: BMS-986156 Drug: Nivolumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
Actual Study Start Date : October 9, 2015
Actual Primary Completion Date : December 16, 2020
Actual Study Completion Date : December 16, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986156: Dose Escalation Drug: BMS-986156
Experimental: BMS-986156 + nivolumab (nivo): Dose Escalation Drug: BMS-986156
Drug: Nivolumab
Experimental: BMS-986156: Dose Expansion Drug: BMS-986156
Experimental: BMS-986156 + nivolumab (nivo): Dose Expansion Drug: BMS-986156
Drug: Nivolumab
Experimental: BMS986156 + Nivo: Cohort Expansion Drug: BMS-986156
Drug: Nivolumab


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Up to 30 days after the last dose of study drug ]
  2. Incidence of Serious Adverse Events [ Time Frame: Up to 30 days after the last dose of study drug ]
  3. Incidence of Adverse Events leading to discontinuation [ Time Frame: Up to 30 days after the last dose of study drug ]
  4. Incidence of Death [ Time Frame: Up to 30 days after the last dose of study drug ]
  5. Incidence of Clinical Laboratory Abnormalities [ Time Frame: Up to 30 days after the last dose of study drug ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  2. Progression free survival rate (PFSR) [ Time Frame: At week 24 ]
  3. Duration of response [ Time Frame: Approximately 3 years ]
  4. Maximum observed concentration (Cmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  5. Time of maximum observed concentration (Tmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  6. Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  7. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  8. Anti-drug antibody (ADA) response to BMS-986156 [ Time Frame: Day 1 to 56 days ]
  9. Anti-drug antibody response to BMS-986156 and Nivolumab [ Time Frame: Day 1 to 56 days ]
  10. Best Overall Response(ORR) [ Time Frame: Approximately 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • For Dose Escalation:

    • Subjects with any previously treated advanced (metastatic or refractory) solid tumor

  • For Cohort Expansion:

    • Subjects must have a previously treated advanced solid tumor to be eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
  • Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

Exclusion Criteria:

  • Known central nervous system metastases or central nervous system as the only source of disease
  • Other concomitant malignancies (with some exceptions per protocol)
  • Active, known or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease
  • History of active or chronic hepatitis (e.g. Hep B or C)
  • Impaired liver or bone marrow function
  • Major surgery less than 1 month before start of the study
Contacts and Locations
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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): NCT02598960


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02598960    
Other Study ID Numbers: CA009-002
2015-002505-11 ( EudraCT Number )
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action