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Completed

NCT Number: NCT03369223

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0038, Buenos Aires, Distrito Federal, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
  • Willing and able to comply with all study procedures

Exclusion criteria

  • Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
  • Other active malignancy requiring concurrent intervention
  • Prior organ allograft
  • Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986249

Biological

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo, BMS-936558

Ipilimumab

Biological

Specified dose on specified days

Other names: Yervoy, BMS-734016

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B

    Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

    Adverse Events (AEs):

    Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment.

    Serious Adverse Events (SAEs):

    Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

  2. Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B

    Time frame: From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)

    Dose-limiting toxicities (DLTs) were defined by the incidence, intensity, and duration of adverse events (AEs) possibly related to study treatment during the 5-week (35-day) DLT evaluation period for both BMS-986249 monotherapy and combination therapy. Participants who received at least 2 doses and completed or discontinued due to a DLT within this period were considered DLT-evaluable. Those who withdrew or received less than 2 doses for reasons other than a DLT were not DLT-evaluable and could be replaced. Any drug-related AE meeting DLT criteria resulted in discontinuation of study treatment. DLTs guided dose escalation and helped define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

  3. Number of Participants Who Died - Part 1 A and 1 B

    Time frame: From enrollment until the date of death from any cause (up to approximately 83 months)

    Number of Participants who Died

  4. Number of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B

    Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

    Number of Participants with Shifts from Baseline in Laboratory Tests

  5. Number of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B

    Time frame: From first dose until 24 weeks after first dose (up to approximately 24 weeks)

    Adverse Events (AEs):

    Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment.

    Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed.

    Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities.

    Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling.

    Grade 4: Life-threatening consequences; urgent intervention required. Grade 5: Death related to the adverse event.

  6. Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F

    Time frame: From randomization until progression or death from any cause (up to approximately 83 months)

    Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1:

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

    Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Secondary outcomes

  1. Time to Deterioration in Part 2A (Arm C, D and F)

    Time frame: Approximately up to 6 months

    TTD in Global Health Status/QoL and Physical Functioning will be defined as the time from randomization until a clinically meaningful decline (i.e., reduction ≥10 points) from baseline in EORTC QLQ-C30 global health/quality of life subscale score and Physical Functioning Scale score.

  2. Safety Related Events in Part 2A (Arm C, D and F) and 2B

    Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

    Adverse Events (AEs):

    Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment.

    Serious Adverse Events (SAEs):

    Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

  3. BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2

    Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

    Best Overall Response (BOR) is defined as the best response recorded from the start of randomization or first dosing date until the date of objectively documented PD based on RECIST v1.1 criteria or PCWG3 (for prostate cancer), or the date of ubsequent therapy (including tumordirected radiotherapy and tumor-directed surgery which are not for palliative purpose), whichever occurs first.

  4. Progression Free Survival

    Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

    Defined as the time between the date of randomization (Part 2A), or first dosing for Part 1 and supplemental analysis in Part 2A, and the date of first documented tumor progression, based on investigator assessments (per RECIST v1.1 criteria or PCWG3), or death due to any cause, whichever occurs first.

  5. Duration of Response

    Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

    Defined as the time between the date of first documented response (CR or PR) to the date of the first documented tumor progression, as determined by RECIST v1.1 or PCWG3 criteria, or death due to any cause, whichever occurs first. Subjects who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who neither progress nor die, DOR will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.

  6. Time to Response

    Time frame: From first dose to first objective response (Approximately up to 3 Months)

    Defined as the time from first dosing (Part 1)/randomization (Part 2A) to the date of the first confirmed documented response (CR or PR). TTR will be evaluated for responders (confirmed CR or PR) only.

  7. Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B

    Time frame: From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

    Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group (PCWG) 3. For both RECIST v1.1 and PCWG3:

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

    Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  8. Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

    Time frame: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)

    Cmax: The highest concentration of BMS-986249 in the blood after dosing. Ctau: The concentration of BMS-986249 in the blood at the end of a dosing interval, just before the next dose

  9. AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

    Time frame: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)

    AUC(0-T): The total amount of BMS-986249 in the blood from the time it is given until a specific time point.

    AUC(TAU): The total amount of BMS-986249 in the blood over one dosing interval

  10. Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B

    Time frame: On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)

    AI_Cmax: How much the highest concentration of BMS-986249 increases after multiple doses compared to a single dose.

    AI_AUC: How much the total exposure to BMS-986249 increases after multiple doses compared to a single dose.

  11. Number of Participants With Shifts From Baseline in Laboratory Test Results - Part 2A (Arms C and F) and 2B

    Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

    Number of Participants with Shifts from Baseline in Laboratory Tests

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2017
Registry last updated
Nov 18, 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.

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