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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.

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ClinicalTrials.gov Identifier: NCT02598960
Recruitment Status : Active, not recruiting
First Posted : November 6, 2015
Last Update Posted : November 12, 2018
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)
Estimated Enrollment : 310 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
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : May 28, 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: Mono therapy - BMS-986156 (Dose Escalation)
BMS-986156 dose as specified
 Drug: BMS-986156
Experimental: Combination therapy - BMS-986156 + Nivolumab (Dose Escalation)
BMS-986156 + Nivolumab dose as specified
 Drug: BMS-986156
Drug: Nivolumab
Experimental: Mono therapy - BMS-986156 (Dose Expansion)
BMS-986156 dose as specified
 Drug: BMS-986156
Experimental: Combination therapy - BMS-986156 + Nivolumab (Dose Expansion)
BMS-986156 + Nivolumab dose as specified
 Drug: BMS-986156
Drug: Nivolumab


Outcome Measures
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Primary Outcome Measures :
  1. Safety of BMS-986156 based on number of incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths in addition to clinical laboratory test 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 ]
    ORR is defined as the proportion of all treated subjects whose best overall response is either a complete response (CR) or partial response (PR)

  2. Progression free survival rate (PFSR) [ Time Frame: Approximately 3 years ]
  3. Duration of response [ Time Frame: Approximately 3 years ]
    Duration of response is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first

  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 ]

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


  Show 27 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site
Investigator Inquiry Form  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02598960     History of Changes
Other Study ID Numbers: CA009-002
2015-002505-11 ( EudraCT Number )
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs