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OpenTrials
Completed

NCT Number: NCT02754141

An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

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Key information

Conditions

Malignant Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0019, Randwick, 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 Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable lab testing results
  • Allow biopsies

Exclusion criteria

  • Central nervous system (CNS) tumors
  • Uncontrolled or significant cardiovascular diseases
  • Active or known autoimmune disease
  • Organ transplant

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986179

Biological

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

rHuPH20

Biological

Specified dose on specified days

Primary outcomes

  1. Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.

    Time frame: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.

    Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths

Secondary outcomes

  1. Number of Participants With a Best Overall Response (BOR) at Week 24

    Time frame: from initial treatment to week 24

    Best overall response (BOR) is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.

  2. Percentage of Participants With an Objective Response Rate (ORR) at Week 24

    Time frame: from initial treatment to week 24

    ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.

  3. Progression Free Survival Rate (PFSR) at Week 24

    Time frame: from initial treatment to week 24

    PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.

  4. Median Duration of Response (DOR)

    Time frame: from first measure response approximately up to 25 months

    DOR (computed for all treated subjects 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.

  5. Cmax

    Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

    Cmax is defined as maximum plasma concentration of the drug

  6. Tmax

    Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

    Tmax is defined is the time to maximum plasma concentration

  7. AUC (0-T)

    Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

    Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration

  8. AUC (Tau)

    Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

    Area under the plasma concentration time-curve. AUC over the dosing interval.

  9. Ctau

    Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days

    Ctau is defined as the concentration of study drug at the end of the dosing interval

  10. Mean Change From Baseline in CD73 Assays

    Time frame: approximately up to 95 weeks

    Mean change from baseline in CD73 assays at the end of Part 1A treatment period

    Assays Measured:

    EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score

    The H-score is given by the ratio of the weighted sum of the number of positive cells to the total number of detected cells. The H-score captures both the intensity and the proportion of the biomarker of interest from the IHC image and comprises values between 0 and 300. The lower the number equals a better prognosis.

  11. Number of Participants With a Positive Anti-drug Antibody (ADA) Test.

    Time frame: From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks

    A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2016
Registry last updated
Apr 5, 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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