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Completed

NCT Number: NCT02913313

A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

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Key information

Conditions

Broad Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0023, CABA, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization

Exclusion criteria

  • Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll
  • Other active malignancy requiring concurrent intervention
  • Uncontrolled or significant cardiovascular disease
  • Active, known, or suspected autoimmune disease
  • NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986207

Drug

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

Ipilimumab

Biological

Specified dose on specified days

Other names: BMS-734016, Yervoy

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

  2. Number of Participants Who Died

    Time frame: From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)

    Participants who died with any cause are considered in the analysis.

  3. Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities

    Time frame: From first dose (Day 1) and up to 6 weeks

    Criteria for Dose-Limiting Toxicities (DLTs): Hepatic DLTs (excluding HCC): Grade (Gr) 4 elevations in AST, ALT, ALP, or total bilirubin. Gr 3 elevations in AST, ALT, or ALP >5 days, with symptoms, or bilirubin >2xULN without cholestasis. Gr 2 AST or ALT with symptomatic liver inflammation. AST or ALT >3xULN and bilirubin >2xULN without cholestasis. Hepatic DLTs for HCC: AST or ALT >10xULN for >2 weeks. AST or ALT >15xULN. Total bilirubin >8xULN (elevated at entry) or >5xULN (normal at entry). ALT ≥10xULN and bilirubin ≥2xULN or baseline, without other causes. Hematologic DLTs: Gr 4 neutropenia ≥7 days. Gr 4 thrombocytopenia. Gr 3 thrombocytopenia with bleeding or platelet transfusion. Febrile neutropenia. Gr 3 hemolysis requiring intervention. Gr 4 anemia not due to underlying disease. Dermatologic DLTs: Gr 4 rash. Gr 3 rash not improving to ≤Gr 1 after 1-2 week delay. Other DLTs: Gr 2-4 eye issues, Gr 3-4 toxicities, excluding specific Gr 3 events like nausea, fever.

  4. Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities

    Time frame: From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)

    Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.

  5. Part 2C: Objective Response Rate (ORR)

    Time frame: From first dose (Day 1) and up to 24 weeks

    ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.

    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.

  6. Part 2C: Duration of Response (DOR)

    Time frame: From first dose (Day 1) and up to 24 weeks

    DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.

    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.

  7. Part 2C: Progression Free Survival Rate at Week 24

    Time frame: Week 24

    Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From first dose (Day 1) and up to 24 weeks

    ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.

    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

  2. Duration of Response

    Time frame: From first dose (Day 1) and up to 24 weeks

    DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.

    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 Rate at Week 24

    Time frame: Week 24

    Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

  4. Maximum Observed Concentration (Cmax) of BMS-986207

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Cmax is defined as maximum plasma concentration of the drug.

  5. BMS-986207 Time to Maximum Concentration (Tmax)

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Time to observed maximum concentration (Tmax) is defined as the amount of time in hours for a drug to reach the maximum concentration after administration.

  6. BMS-986207 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    BMS-986207 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).

  7. BMS-986207 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Blood samples were collected for assessing AUC (TAU).

  8. BMS-986207 Observed Serum Concentration at the End of a Dosing Interval (Ctau)

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Blood samples were collected for assessing Ctau.

  9. BMS-986207 Total Body Clearance (CLT)

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Blood samples were collected for assessing CLT.

  10. BMS-986207 Average Concentration Over a Dosing Interval (Css-avg)

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Blood samples were collected for assessing Css-avg.

  11. BMS-986207 Ratio of an Exposure Measure at Steady State to That After the First Dose (AI_TAU)

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Blood samples were collected for assessing AI_TAU.

  12. BMS-986207 Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (T-HALFeff)

    Time frame: Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

    Blood samples were collected for assessing T-HALFeff. Exposure measure includes AUC[TAU].

  13. Number of Participants With Positive Anti-BMS-986207-Antibodies Results

    Time frame: From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)

    Participants who were treated with BMS-986207 and at least one post-baseline evaluable ADA assessment were considered in the analysis

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2016
Registry last updated
Apr 20, 2025

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.