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Completed

NCT Number: NCT02598960

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 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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Liverpool Cancer Therapy Center, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986156

Drug

Nivolumab

Drug

Primary outcomes

  1. Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths

    Time frame: From first treatment to 100 days post last dose. Approximately 29 months

    Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths.

    AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.

  2. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

    Time frame: From first treatment to 100 days post last dose. Approximately 29 months

    Number of Participants with laboratory abnormalities in specific thyroid tests.

    TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number

  3. Number of Participants With Laboratory Abnormalities in Specific Liver Tests

    Time frame: From first treatment to 100 days post last dose. Approximately 29 months

    Number of Participants with laboratory abnormalities in specific liver tests.

    ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase

Secondary outcomes

  1. Best Overall Response

    Time frame: From first dose to a response or progressive disease (Approximately 50 Months)

    BOR will be defined by CR, PR, PD and SD

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  2. Overall Response Rate

    Time frame: From first dose to CR and PR (Approximately 50 Months)

    Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR).

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  3. Progression Free Survival (PFS)

    Time frame: From first dose to disease progression (Approximately 50 Months)

    The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.

    Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

  4. Duration of Response

    Time frame: From first dose to disease progression after a response (Approximately 50 Months)

    All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  5. Number of Participants With Anti-Drug Antibody Response

    Time frame: At Cycle 3 Day 1; where each treatment cycle was 8 weeks

    Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2015
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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