First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

April 21, 2025 updated by: Bristol-Myers Squibb

Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina, 1426
        • Local Institution - 0042
    • Ciudad Autónoma De Buenos Aires
      • ABB, Ciudad Autónoma De Buenos Aires, Argentina, C1199ABB
        • Local Institution - 0053
      • Caba, Ciudad Autónoma De Buenos Aires, Argentina, C1430EGF
        • Local Institution - 0057
    • Cordoba
      • Córdoba, Cordoba, Argentina, X5000FHP
        • Local Institution - 0062
      • Rio Cuarto, Cordoba, Argentina
        • Local Institution - 0060
      • Villa Siburu, Cordoba, Argentina, 5003
        • Local Institution - 0047
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, 1121
        • Local Institution - 0059
  • Australia
    • New South Wales
      • Northmead, New South Wales, Australia, 2152
        • Local Institution - 0026
      • Wollstonecraft, New South Wales, Australia, 2065
        • Local Institution - 0006
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0049
  • Belgium
      • Gent, Belgium, 9000
        • Local Institution - 0039
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0037
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0023
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0027
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0022
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8420383
        • Local Institution - 0041
      • Santiago, Metropolitana, Chile, 7710007
        • Local Institution - 0048
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0052
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution - 0045
  • France
      • Lyon Cedex 08, France, 69373
        • Local Institution - 0019
      • Toulouse Cedex 9, France, 31059
        • Local Institution - 0020
      • Villejuif, France, 94800
        • Local Institution - 0018
  • Germany
      • Dresden, Germany, 01307
        • Local Institution - 0009
      • Essen, Germany, 45147
        • Local Institution - 0030
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution - 0029
      • Ramat Gan, Israel, 52621
        • Local Institution - 0008
  • Italy
      • Napoli, Italy, 80131
        • Local Institution - 0011
      • Rozzano, Italy, 20089
        • Local Institution - 0061
      • Siena, Italy, 53100
        • Local Institution - 0010
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0038
      • Nijmegen, Netherlands, 6525 GA
        • Local Institution - 0043
  • Norway
      • Oslo, Norway, 0379
        • Local Institution - 0040
  • Poland
      • Warszawa, Poland, 02-781
        • Local Institution - 0036
  • Romania
      • Cluj Napoca, Romania, 400015
        • Local Institution - 0034
      • Craiova, Romania, 200347
        • Local Institution - 0035
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0014
      • Madrid, Spain, 28007
        • Local Institution - 0056
      • Madrid, Spain, 28040
        • Local Institution - 0055
      • Madrid, Spain, 28050
        • Local Institution - 0013
      • Malaga, Spain, 29010
        • Local Institution - 0054
      • Pamplona, Spain, 31008
        • Local Institution - 0012
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Local Institution - 0017
      • Zuerich, Switzerland, 8091
        • Local Institution - 0031
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0058
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0025
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0002
      • New Brunswick, New Jersey, United States, 08009
        • Local Institution - 0028
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0007
      • New York, New York, United States, 10032
        • Local Institution - 0001
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • Local Institution - 0015
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0004
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Local Institution - 0033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
  • Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
  • Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C)
  • Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)

Exclusion Criteria:

  • Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1A: Monotherapy (BMS-986218)
Biological: BMS-986218
Specified dose on specified days
Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: BMS-986218
Specified dose on specified days
Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Biological: BMS-986218
Specified dose on specified days
Experimental: Part 2B: Monotherapy (BMS-986218)
Biological: BMS-986218
Specified dose on specified days
Experimental: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: BMS-986218
Specified dose on specified days
Experimental: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: BMS-986218
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Time Frame: From first dose of study medication through 60 days following last dose of study treatment (assessed for an average of 7 months up to a max of approximately 27 months)

Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment.

Grade 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death

Gastrointestinal DLT:

  • Grade 2 colitis >5 days
  • Grade ≥3 diarrhea/colitis

Hepatic DLT:

  • Grade 4 serum transaminases (AST & ALT), alkaline phosphatase (ALP), or total bilirubin elevations
  • Grade 3 serum AST, ALT, or ALP elevations lasting >5 days or with clinical symptoms or bilirubin > 2×ULN without cholestasis

Hematologic DLT:

  • Grade 4 neutropenia ≥7 days
  • Grade 4 thrombocytopenia

Dermatologic DLT:

  • Grade 4 rash
  • Grade 3 rash if no improvement after 1-2-week infusion delay

Other DLTs:

  • Grade 2 drug-related uveitis, episcleritis, iritis, eye pain, or blurred vision that doesn't respond to treatment, doesn't improve within the re-treatment period OR requires systemic treatment
  • Grade 3 drug-related uveitis, episcleritis, iritis, pneumonitis, bronchospasm, or neurologic toxicity
From first dose of study medication through 60 days following last dose of study treatment (assessed for an average of 7 months up to a max of approximately 27 months)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Time Frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Number of Participants Who Died
Time Frame: From randomization (Part 2A and 2B) or first dose (Part 1, 2C and 2D) until study closure (Up to approximately 83 months)
Number of participants who died during the study
From randomization (Part 2A and 2B) or first dose (Part 1, 2C and 2D) until study closure (Up to approximately 83 months)
Objective Response Rate (ORR) for Part 2 Only
Time Frame: From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)

Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator 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 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 the 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).
From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
Median Duration of Response (mDOR) for Part 2 Only
Time Frame: From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)

Duration of response (DOR) for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 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.

Progressive Disease (PD): At least a 20% increase in the sum of the 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, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Based on Kaplan-Meier estimates of duration of response
From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only
Time Frame: At 24, 36, and 48 weeks

Progression-free survival (PFS) for a participant is defined as 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.

Based on Kaplan-Meier estimates of progression-free survival rate

Progressive Disease (PD): At least a 20% increase in the sum of the 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).
At 24, 36, and 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) for Part1A and Part1B Only
Time Frame: From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)

Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator 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 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 the 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).
From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
Median Duration of Response (mDOR) for Part1A and Part1B Only
Time Frame: From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)

Duration of response (DOR) for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 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.

Progressive Disease (PD): At least a 20% increase in the sum of the 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, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Based on Kaplan-Meier estimates of duration of response
From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only
Time Frame: At 24, 36, and 48 weeks

Progression-free survival (PFS) for a participant is defined as 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.

Progressive Disease (PD): At least a 20% increase in the sum of the 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, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Based on Kaplan-Meier estimates of progression-free survival rate
At 24, 36, and 48 weeks
Maximum Observed Serum Concentration (Cmax) for BMS-986218
Time Frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Cmax is the maximum observed serum concentration for BMS-986218.
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218
Time Frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218.
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218
Time Frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval for BMS-986218.
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218
Time Frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Ctau is the observed serum concentration at the end of the dosing interval for BMS-986218.
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Total Body Clearance (CLT/F) for BMS-986218
Time Frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218
Time Frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218
Time Frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218
Time Frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Terminal Serum Half-life (T-HALF) for BMS-986218
Time Frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Time of Maximum Observed Concentration (Tmax) for BMS-986218
Time Frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218.
On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Trough Observed Plasma Concentration (Ctrough) for BMS-986218
Time Frame: At Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1 (Each Cycle is of 28 Days)
Ctrough is the lowest observed serum concentration for BMS-986218.
At Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1 (Each Cycle is of 28 Days)
Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218
Time Frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)

Baseline ADA Positive: Participant with baseline ADA-positive sample

ADA Positive: Participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment

Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints, where the first and last ADA-positive samples are at least 16weeks apart

Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint

Other Positive: Not persistent but some ADA-positive samples with the last sample being negative

ADA Negative: Participant with no ADA-positive sample after initiation of treatment
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA022-001
  • 2017-000597-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Cancer

Clinical Trials on Nivolumab

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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