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

November 6, 2025 updated by: Bristol-Myers Squibb

A Phase 1/2 First-in-Human 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

Study Overview

Status

Status

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

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.
356

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, Argentina, C1426ANZ
        • Local Institution - 0037
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, 1121
        • Local Institution - 0038
      • CABA, Distrito Federal, Argentina, C1430
        • Local Institution - 0052
  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Local Institution - 0015
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0014
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Local Institution - 0025
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0047
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0026
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0056
  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0036
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution - 0039
  • Germany
      • Essen, Germany, 45147
        • Local Institution - 0030
      • Hamburg, Germany, 20251
        • Local Institution - 0035
      • Heidelberg, Germany, 69120
        • Local Institution - 0031
  • Italy
      • Milan, Italy, 20133
        • Local Institution - 0048
      • Napoli, Italy, 80131
        • Local Institution - 0020
      • Siena, Italy, 53100
        • Local Institution - 0049
  • Poland
      • Warsaw, Poland, 02-781
        • Local Institution - 0040
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0045
      • Craiova, Romania, 200542
        • Local Institution - 0041
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0044
      • Madrid, Spain, 28040
        • Local Institution - 0023
      • Madrid, Spain, 28041
        • Local Institution - 0050
      • Málaga, Spain, 29010
        • Local Institution - 0043
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Local Institution - 0042
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28027
        • Local Institution - 0022
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0005
      • Denver, Colorado, United States, 80218
        • Local Institution - 0006
    • Florida
      • Miami, Florida, United States, 33176
        • Local Institution - 0017
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0024
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0001
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0003
      • New York, New York, United States, 10032
        • Local Institution - 0002
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Local Institution - 0029
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Local Institution - 0013
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0004
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Local Institution - 0008
    • Texas
      • Austin, Texas, United States, 78705-1165
        • Local Institution - 0010
      • Dallas, Texas, United States, 75246
        • Local Institution - 0009
      • Houston, Texas, United States, 77030
        • Local Institution - 0021
      • San Antonio, Texas, United States, 78240
        • Local Institution - 0016
      • Tyler, Texas, United States, 75702
        • Local Institution - 0011
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Local Institution - 0012
      • Norfolk, Virginia, United States, 23502
        • Local Institution - 0007
    • Washington
      • Vancouver, Washington, United States, 98684
        • Local Institution - 0018

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: BMS-986249
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 1B: BMS-986249 + nivolumab (nivo)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2B Cohort 1: BMS-986249 + nivo
Advanced or intermediate hepatocellular carcinoma (HCC)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm B: BMS-986249 + nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986249
Specified dose on specified days
Experimental: Part 2A Arm E: Nivo
  • Previously untreated unresectable stage III-IV melanoma
  • Enrollment is closed for this Arm
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

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) 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.
From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
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).
From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)
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
From enrollment until the date of death from any cause (up to approximately 83 months)
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
From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
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.
From first dose until 24 weeks after first dose (up to approximately 24 weeks)
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.
From randomization until progression or death from any cause (up to approximately 83 months)

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
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.
Approximately up to 6 months
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.
From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)
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.
From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
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.
From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
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.
From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
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.
From first dose to first objective response (Approximately up to 3 Months)
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.
From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)
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
On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
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
On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
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.
On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)
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
From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

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.
December 6, 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.
November 7, 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.
November 7, 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).
December 6, 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.
December 8, 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.
December 11, 2017

Study Record Updates

Last Update Posted (Estimated)

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.
November 18, 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.
November 6, 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.
November 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.
  • CA030-001
  • 2018-000416-21 (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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings