Advanced Solid TumorsPhase 1NCT04943900
A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
A Phase 1 study testing BMS-986416 and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 19 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BMS-986416 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 9 Aug 2021to 27 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
- Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
- Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
- Disease amenable to serial biopsy
Who cannot join
- Uncontrolled or significant cardiovascular disease
- Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
- Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
United States6 sites
Local Institution - 0006
Atlanta, Georgia, 30322
Local Institution - 0005
Baltimore, Maryland, 21287
Local Institution - 0013
Cleveland, Ohio, 44106-1716
Local Institution - 0002
Hackensack, New Jersey, 07601
Local Institution - 0004
Houston, Texas, 77030
Local Institution - 0003
Pittsburgh, Pennsylvania, 15232
Argentina3 sites
Local Institution - 0027
ABB, Buenos Aires F.D., C1199ABB
Local Institution - 0022
CABA, Buenos Aires F.D., C1430EGF
Local Institution - 0021
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Canada3 sites
Local Institution - 0009
Edmonton, Alberta, T6X 1E8
Local Institution - 0001
Montreal, Quebec, H2X 3H8
Local Institution - 0008
Toronto, Ontario, M5G 2M9
Chile3 sites
Local Institution - 0025
Santiago, Santiago Metropolitan, 7500921
Local Institution - 0026
Santiago, Santiago Metropolitan, 7620002
Local Institution - 0024
Santiago, Santiago Metropolitan, 8420383
Belgium2 sites
Local Institution - 0043
Edegem, Antwerpen, 2650
Local Institution - 0016
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986416, Nivolumab
- Keywords
- BMS-986416, Nivolumab, Opdivo, Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), Pancreatic ductal adenocarcinoma (PDAC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986416Drug
Specified dose on specified days
NivolumabDrug
Also called BMS-936558, Opdivo
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: Monotherapy (BMS-986416) | Experimental | Not described Receives: Drug: BMS-986416 |
| Part 1B: Combination Therapy (BMS-986416 + Nivolumab) | Experimental | Not described Receives: Drug: BMS-986416; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Measured: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to discontinuation
Measured: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
Measured: Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
Measured: Up to 100 days after the last treatment of study intervention(s)
Secondary outcomes (6)
Maximum observed serum concentration (Cmax) of BMS-986416
Measured: Up to 100 days after the last treatment of study intervention(s)
Time of maximum observed serum concentration (Tmax) of BMS-986416
Measured: Up to 100 days after the last treatment of study intervention(s)
Trough observed serum concentration (Ctrough) of BMS-986416
Measured: Up to 100 days after the last treatment of study intervention(s)
Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment
Measured: Up to 2 years
Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
Measured: Up to 2 years
Incidence of clinically significant changes in ECG parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Measured: Up to 100 days after the last treatment of study intervention(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start9 Aug 2021
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943900
- Sponsor's protocol ID
- CA102-003
- Status last verified
- Apr 2025
- First submitted
- 25 Jun 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
- ClinicalTrials.gov ID
- NCT04943900
- Acronym / sponsor ID
- CA102-003
- Conditions
- Advanced Solid Tumors
- Keywords
- BMS-986416, Nivolumab, Opdivo, Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
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 the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Monotherapy (BMS-986416) | Experimental | Drug: BMS-986416 |
| Part 1B: Combination Therapy (BMS-986416 + Nivolumab) | Experimental | Drug: BMS-986416, Drug: 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)
- Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
- Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
- Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
- Disease amenable to serial biopsy
Key exclusion criteria (4 listed)
- Uncontrolled or significant cardiovascular disease
- Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
- Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)
- Other protocol-defined inclusion/exclusion criteria apply
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-986416Specified dose on specified days | Drug | Part 1A: Monotherapy (BMS-986416), Part 1B: Combination Therapy (BMS-986416 + Nivolumab) |
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Drug | Part 1B: Combination Therapy (BMS-986416 + Nivolumab) |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to discontinuation
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
Time frame: Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
Time frame: Up to 100 days after the last treatment of study intervention(s)
6 secondary outcomes
Maximum observed serum concentration (Cmax) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Time of maximum observed serum concentration (Tmax) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Trough observed serum concentration (Ctrough) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment
Time frame: Up to 2 years
Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
Time frame: Up to 2 years
Incidence of clinically significant changes in ECG parameters: QTcF
Time frame: Up to 100 days after the last treatment of study intervention(s)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Related trials for Advanced Solid Tumors
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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986416 and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 19 sites in 7 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 5 inclusion and 4 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Argentina, Canada, Chile, Belgium and 2 more countries. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Adverse Events (AEs) (time frame: Up to 100 days after the last treatment of study intervention(s)). 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?
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 9 Apr 2025.