CancerPhase 1/2NCT03351231

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

A Phase 1/2 study testing BMS-986242 and Nivolumab in people with Cancer, run by Bristol-Myers Squibb at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: BMS-986242 and Nivolumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 4 sitesUnited States
Study dates: 27 Nov 2017to 28 Aug 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Local Institution
Baltimore, Maryland, 21287
University Of Alabama At Birmingham
Birmingham, Alabama, 35294-3300
Hoag Memorial Hospital Presbyterian
Los Angeles, California, 90033
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033

Other trials in United States

About this study

Official title: 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.

Conditions: Cancer
Being tested: BMS-986242, Nivolumab
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986242Drug
Specified dose on specified days
NivolumabBiological
Also called BMS-936558, Anti-PD-1
Specified dose on specified days

Study groups in NCT03351231
Study group	Role	What they receive
Dose Escalation	Experimental	BMS-986242 administered in combination with Nivolumab Receives: Drug: BMS-986242; Biological: Nivolumab
Dose Expansion	Experimental	BMS-986242 administered in combination with Nivolumab Receives: Drug: BMS-986242; Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AE)
The primary objective to establish safety to be measured by the primary endpoint of AEs
Measured: From initiation of study treatment until 100 days after discontinuation of study treatment
Number of Participants With Serious Adverse Events (SAE)
The primary objective to establish safety to be measured by the primary endpoint of SAEs
Measured: 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)
The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities
Measured: Approximately 2 years
Number of Participants With AEs Leading to Discontinuation
The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation
Measured: Approximately 2 years
Number of Deaths
The primary objective to establish safety to be measured by the primary endpoint of deaths
Measured: Approximately 2 years
Number of Participants With Laboratory Abnormalities
The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities
Measured: Approximately 2 years

Secondary outcomes (13)

Maximum Observed Plasma Concentration (Cmax)
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
Measured: Approximately 2 years
Time of Maximum Observed Plasma Concentration (Tmax)
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
Measured: Approximately 2 years
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
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
Measured: Approximately 2 years
Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]
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
Measured: Approximately 2 years
Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)
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
Measured: Approximately 2 years
Apparent Elimination Half-life (T-HALF)
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
Measured: Approximately 2 years
Apparent Total Body Clearance (CLT/F)
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
Measured: Approximately 2 years
Apparent Volume of Distribution at Steady State (Vss/F)
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
Measured: Approximately 2 years
Accumulation Index (AI)
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.
Measured: Approximately 2 years
Percent Urinary Recovery Over 24 Hours (%UR24)
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
Measured: Approximately 2 years
Percent Urinary Recovery Over 72 Hours (%UR72)
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
Measured: Approximately 2 years
Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242
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.
Measured: Approximately 2 years
Overall Response Rate (ORR)
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
Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 201728 Aug 2018

First posted22 Nov 2017
Study start27 Nov 2017
Primary completion28 Aug 2018
Study completion28 Aug 2018

Why it stopped: Inability to meet protocol objectives

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03351231
Sponsor's protocol ID: CA024-001
Other IDs: 2017-003603-21, 2017
Status last verified: Aug 2020
First submitted: 20 Nov 2017
Last updated: 26 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Study of BMS-986242 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1) in Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT03351231
Acronym / sponsor ID: CA024-001
Conditions: Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inability to meet protocol objectives
Enrolment: 7 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 27 Nov 2017 (actual)
Primary completion: 28 Aug 2018 (actual)
Study completion: 28 Aug 2018 (actual)
First posted: 22 Nov 2017 (actual)
Results: Posted 8 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dose Escalation	Experimental	Drug: BMS-986242, Biological: NivolumabBMS-986242 administered in combination with Nivolumab
Dose Expansion	Experimental	Drug: BMS-986242, Biological: NivolumabBMS-986242 administered in combination with Nivolumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMS-986242Specified dose on specified days	Drug	Dose Escalation, Dose Expansion
NivolumabAlso: BMS-936558, Anti-PD-1Specified dose on specified days	Biological	Dose Escalation, Dose Expansion

Primary outcome

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
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
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
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
Number of Deaths
Time frame: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of deaths
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

13 secondary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: Approximately 2 years
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Approximately 2 years
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
Time frame: Approximately 2 years
Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]
Time frame: Approximately 2 years
Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)
Time frame: Approximately 2 years
Apparent Elimination Half-life (T-HALF)
Time frame: Approximately 2 years
Apparent Total Body Clearance (CLT/F)
Time frame: Approximately 2 years
Apparent Volume of Distribution at Steady State (Vss/F)
Time frame: Approximately 2 years
Accumulation Index (AI)
Time frame: Approximately 2 years
Percent Urinary Recovery Over 24 Hours (%UR24)
Time frame: Approximately 2 years
Percent Urinary Recovery Over 72 Hours (%UR72)
Time frame: Approximately 2 years
Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242
Time frame: Approximately 2 years
Overall Response Rate (ORR)
Time frame: Approximately 2 years

Results and safety

Results posted to the registry on 8 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BMS-986242 12.5 mg + Nivolumab 480 mg	5	0

Primary outcome: Number of Participants With Adverse Events (AE)

Time frame: From initiation of study treatment until 100 days after discontinuation of study treatment. Number. Unit: Number of participants

Measure	BMS-986242 12.5 mg + Nivolumab 480 mg n = 5
Value	NA

Population analysed: Study terminated, data not reported due to privacy reasons

Primary outcome: 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. Number. Unit: Number of participants

Measure	BMS-986242 12.5 mg + Nivolumab 480 mg n = 5
Value	NA

Population analysed: Study terminated, data not reported due to privacy reasons

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLT)

Time frame: Approximately 2 years. Number. Unit: Number of participants

Measure	BMS-986242 12.5 mg + Nivolumab 480 mg n = 5
Value	NA

Population analysed: Study terminated, data not reported due to privacy reasons

Primary outcome: Number of Participants With AEs Leading to Discontinuation

Time frame: Approximately 2 years. Number. Unit: Number of participants

Measure	BMS-986242 12.5 mg + Nivolumab 480 mg n = 5
Value	NA

Population analysed: Study terminated, data not reported due to privacy reasons

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) are monitored from initiation of study treatment (monitored from participant's written consent for Serious Adverse Events) up through 100 days post-End of Treatment (EOT); Study Start of December 2017 and Study End of August 2018 (assessed approximately 1 year). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BMS-986242 12.5 mg + Nivolumab 480 mg	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986242 and Nivolumab in people with Cancer, run by Bristol-Myers Squibb at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AE) (time frame: From initiation of study treatment until 100 days after discontinuation of study treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03351231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.