Advanced Solid TumorPhase 1/2NCT04349267

Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

A Phase 1/2 study testing BMS-986315, nivolumab and cetuximab in people with Advanced Solid Tumor, run by Bristol-Myers Squibb at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor
What is being tested?: BMS-986315, nivolumab and cetuximab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 8 sitesin 3 countries
Study dates: 14 Jul 2020to 22 Aug 2024
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

Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
Eastern cooperative oncology group performance status of 0 or 1
Women of childbearing potential must agree to follow methods of contraception

Who cannot join

Participants with active, known or suspected autoimmune disease
Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Uncontrolled or significant cardiovascular disease
History of or with active interstitial lung disease or pulmonary fibrosis
Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
History of allergy or hypersensitivity to study drug components
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Canada5 sites

Local Institution - 0014
Edmonton, Alberta, T6X 1E8
Local Institution - 0005
Montreal, Quebec, H2X 3E4
Local Institution - 0013
Ottawa, K1H 8L6
Local Institution - 0004
Toronto, Ontario, M5G 2M9
Local Institution - 0011
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

United States2 sites

Local Institution - 0001
Germantown, Tennessee, 38138
Local Institution - 0028
Sioux Falls, South Dakota, 57104

Other trials in United States

Mexico1 site

Local Institution
Mexico City, Mexico City, 06100

Other trials in Mexico

About this study

Official title: A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Conditions: Advanced Solid Tumor
Being tested: BMS-986315, nivolumab, cetuximab
Keywords: NSCLC (Non-small cell lung cancer), RCC (Renal cell carcinoma), SCCHN (Squamous cell carcinoma of the head and neck)
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell

What participants receive

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

BMS-986315Biological
Specified dose on specified days
nivolumabBiological
Specified dose on specified days
cetuximabBiological
Specified dose on specified days

Study groups in NCT04349267
Study group	Role	What they receive
BMS-986315	Experimental	Not described Receives: Biological: BMS-986315
BMS-986315 + nivolumab	Experimental	Not described Receives: Biological: BMS-986315; Biological: nivolumab
BMS-986315 + cetuximab	Experimental	Not described Receives: Biological: BMS-986315; Biological: cetuximab

What is being measured

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

Number of Participants With Adverse Events and Deaths
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. 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.
Measured: From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.
Measured: From first dose (Day 1) untill Day 28

Secondary outcomes (9)

Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
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 diameters of target lesions, taking as reference the smallest sum during the 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 5 mm.
Measured: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
Duration of Response (DoR)
DOR for a participant with a best overall response (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 by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method.
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 diameters of target lesions, taking as reference the smallest sum during the 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 5 mm.
Measured: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
Progression Free Survival (PFS) Rate
Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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 5 mm.
Measured: At 6 months
Maximum Plasma Concentration (Cmax) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Measured: Cycle 1 Day 1
Time to Maximum Plasma Concentration (Tmax) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Measured: Cycle 1 Day 1
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Measured: Cycle 1 Day 1
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Measured: Cycle 1 Day 1
Concentration in a Dosing Interval (Ctau) of BMS-986315
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Measured: Cycle 1 Day 1
Number of Participants With Anti-Drug Antibody (ADA)
An ADA positive participant was defined as 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.
Measured: Cycle 1 Day 1

Timeline

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

14 Jul 202022 Aug 2024

First posted16 Apr 2020
Study start14 Jul 2020
Primary completion22 Aug 2024
Study completion22 Aug 2024

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 Advanced Solid TumorStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04349267
Sponsor's protocol ID: CA047-004
Status last verified: Dec 2025
First submitted: 15 Apr 2020
Last updated: 17 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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?

See locations

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All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04349267
Acronym / sponsor ID: CA047-004
Conditions: Advanced Solid Tumor
Keywords: NSCLC (Non-small cell lung cancer), RCC (Renal cell carcinoma), SCCHN (Squamous cell carcinoma of the head and neck)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 14 Jul 2020 (actual)
Primary completion: 22 Aug 2024 (actual)
Study completion: 22 Aug 2024 (actual)
First posted: 16 Apr 2020 (actual)
Results: Posted 17 Dec 2025

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 evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BMS-986315	Experimental	Biological: BMS-986315
BMS-986315 + nivolumab	Experimental	Biological: BMS-986315, Biological: nivolumab
BMS-986315 + cetuximab	Experimental	Biological: BMS-986315, Biological: cetuximab

Who may qualify

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

Key inclusion criteria (4 listed)

Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
Eastern cooperative oncology group performance status of 0 or 1
Women of childbearing potential must agree to follow methods of contraception

Key exclusion criteria (7 listed)

Participants with active, known or suspected autoimmune disease
Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Uncontrolled or significant cardiovascular disease
History of or with active interstitial lung disease or pulmonary fibrosis
Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study

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-986315Specified dose on specified days	Biological	BMS-986315, BMS-986315 + cetuximab, BMS-986315 + nivolumab
nivolumabSpecified dose on specified days	Biological	BMS-986315 + nivolumab
cetuximabSpecified dose on specified days	Biological	BMS-986315 + cetuximab

Primary outcome

Number of Participants With Adverse Events and Deaths
Time frame: From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. 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.
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: From first dose (Day 1) untill Day 28
A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.

9 secondary outcomes

Objective Response Rate (ORR)
Time frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
Duration of Response (DoR)
Time frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)
Progression Free Survival (PFS) Rate
Time frame: At 6 months
Maximum Plasma Concentration (Cmax) of BMS-986315
Time frame: Cycle 1 Day 1
Time to Maximum Plasma Concentration (Tmax) of BMS-986315
Time frame: Cycle 1 Day 1
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315
Time frame: Cycle 1 Day 1
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315
Time frame: Cycle 1 Day 1
Concentration in a Dosing Interval (Ctau) of BMS-986315
Time frame: Cycle 1 Day 1
Number of Participants With Anti-Drug Antibody (ADA)
Time frame: Cycle 1 Day 1

Results and safety

Results posted to the registry on 17 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1A BMS-986315-80 mg	2	0
Part 1A BMS-986315-200 mg	2	0
Part 1A BMS-986315-600 mg	3	1
Part 1A BMS-986315-1200 mg	3	0
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	5	1
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	14	5
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	15	3

Primary outcome: Number of Participants With Adverse Events and Deaths

Time frame: From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months). Count of participants. Unit: Participants

Measure	Part 1A BMS-986315-80 mg n = 2	Part 1A BMS-986315-200 mg n = 2	Part 1A BMS-986315-600 mg n = 3	Part 1A BMS-986315-1200 mg n = 3	Part 1B BMS-986315-200 mg + Nivolumab 480 mg n = 5	Part 1B BMS-986315-600 mg + Nivolumab 480 mg n = 14	Part 1B BMS-986315-1200 mg + Nivolumab 480 mg n = 15
Any adverse events	2	2	3	3	5	14	15
Serious Adverse Events	0	2	0	0	3	8	10
AEs leading to discontinuation	0	1	0	0	0	2	2
Deaths	1	1	0	0	1	2	4

Population analysed: All treated participants

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

Time frame: From first dose (Day 1) untill Day 28. Count of participants. Unit: Participants

Measure	Part 1A BMS-986315-80 mg n = 2	Part 1A BMS-986315-200 mg n = 2	Part 1A BMS-986315-600 mg n = 3	Part 1A BMS-986315-1200 mg n = 3	Part 1B BMS-986315-200 mg + Nivolumab 480 mg n = 5	Part 1B BMS-986315-600 mg + Nivolumab 480 mg n = 14	Part 1B BMS-986315-1200 mg + Nivolumab 480 mg n = 15
Value	0	0	0	0	0	0	0

Population analysed: All treated participants.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1A BMS-986315-80 mg	0 of 2 (0%)	2 of 2 (100%)	1 of 2
Part 1A BMS-986315-200 mg	2 of 2 (100%)	1 of 2 (50%)	1 of 2
Part 1A BMS-986315-600 mg	0 of 3 (0%)	3 of 3 (100%)	3 of 3
Part 1A BMS-986315-1200 mg	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Part 1B BMS-986315-200 mg + Nivolumab 480 mg	3 of 5 (60%)	4 of 5 (80%)	4 of 5
Part 1B BMS-986315-600 mg + Nivolumab 480 mg	8 of 14 (57.1%)	14 of 14 (100%)	7 of 14
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg	10 of 15 (66.7%)	15 of 15 (100%)	14 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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.

Related trials for Advanced Solid Tumor

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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

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986315, nivolumab and cetuximab in people with Advanced Solid Tumor, run by Bristol-Myers Squibb at 8 sites in 3 countries.

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 4 inclusion and 7 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: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, United States, Mexico. 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 17 Dec 2025). 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 and Deaths (time frame: From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)). The study lists 2 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 NCT04349267.

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 17 Dec 2025.