An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer

August 24, 2020 updated by: Bristol-Myers Squibb

A Phase 1/2a Study of BMS-986242 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1) in Advanced Malignant Tumors

The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.

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.
7

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Hoag Memorial Hospital Presbyterian
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution

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

Genders Eligible for Study

All

Description

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

Inclusion Criteria:

  • Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
  • Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy exists
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Ability to swallow tablets
  • Adequate bone marrow and organ function, as defined by the protocol

Exclusion Criteria:

  • Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
  • Ocular melanoma
  • Any significant acute or chronic medical illness
  • Prior malignancy
  • Other active malignancy requiring concurrent intervention
  • Prior organ allograft or allogeneic bone marrow transplantation
  • Participants with active, known, or suspected autoimmune disease
  • Requirement for daily supplemental oxygen
  • Uncontrolled or significant cardiovascular disease
  • Pre-existing liver disease
  • Gastrointestinal disease known to interfere with absorption

Other protocol defined inclusion/exclusion criteria could 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: Non-Randomized
  • Interventional Model: Sequential 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: Dose Escalation
BMS-986242 administered in combination with Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Anti-PD-1
Drug: BMS-986242
Specified dose on specified days
Experimental: Dose Expansion
BMS-986242 administered in combination with Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Anti-PD-1
Drug: BMS-986242
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 (AE)
Time Frame: From initiation of study treatment until 100 days after discontinuation of study treatment
The primary objective to establish safety to be measured by the primary endpoint of AEs
From initiation of study treatment until 100 days after discontinuation of study treatment
Number of Participants With Serious Adverse Events (SAE)
Time Frame: From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study
The primary objective to establish safety to be measured by the primary endpoint of SAEs
From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study
Number of Participants With Dose Limiting Toxicities (DLT)
Time Frame: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities
Approximately 2 years
Number of Participants With AEs Leading to Discontinuation
Time Frame: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation
Approximately 2 years
Number of Deaths
Time Frame: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of deaths
Approximately 2 years
Number of Participants With Laboratory Abnormalities
Time Frame: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities
Approximately 2 years

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
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Time of Maximum Observed Plasma Concentration (Tmax)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Apparent Elimination Half-life (T-HALF)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Apparent Total Body Clearance (CLT/F)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Apparent Volume of Distribution at Steady State (Vss/F)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Accumulation Index (AI)
Time Frame: Approximately 2 years

The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0.

Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose.
Approximately 2 years
Percent Urinary Recovery Over 24 Hours (%UR24)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Percent Urinary Recovery Over 72 Hours (%UR72)
Time Frame: Approximately 2 years
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Approximately 2 years
Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242
Time Frame: Approximately 2 years
Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.
Approximately 2 years
Overall Response Rate (ORR)
Time Frame: Approximately 2 years
ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors
Approximately 2 years

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

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.
November 27, 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.
August 28, 2018

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.
August 28, 2018

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).
November 20, 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.
November 20, 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.
November 22, 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.
August 26, 2020

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.
August 24, 2020

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.
August 1, 2020

More Information

Terms related to this study

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.
  • CA024-001
  • 2017-003603-21 (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.

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