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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.

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02598960
First Posted: November 6, 2015
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Solid Tumors Drug: BMS-986156 Drug: Nivolumab Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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)

  • Progression free survival rate (PFSR) [ Time Frame: Approximately 3 years ]
  • 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

  • Maximum observed concentration (Cmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Time of maximum observed concentration (Tmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • 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 ]
  • Anti-drug antibody (ADA) response to BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Anti-drug antibody response to BMS-986156 and Nivolumab [ Time Frame: Day 1 to 56 days ]

Estimated Enrollment: 310
Actual Study Start Date: October 9, 2015
Estimated Study Completion Date: February 1, 2019
Estimated Primary Completion Date: January 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02598960     History of Changes
Other Study ID Numbers: CA009-002
2015-002505-11 ( EudraCT Number )
First Submitted: October 21, 2015
First Posted: November 6, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

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