Advanced Solid TumorsPhase 1/2NCT05888831
A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors
A Phase 1/2 study testing BMS-986449 and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 20 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab 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 Tumors
- What is being tested?
- BMS-986449 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 6 Jun 2023to 30 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- Part 1A may have a solid malignancy of any histology.
- Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
- Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
- Tumor biopsy must be obtained for all participants (unless medically precluded).
Who cannot join
- History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
- Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- Other protocol-defined criteria may apply.
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Spain5 sites
Local Institution - 0013
Badalona, Barcelona [Barcelona], 08916
Local Institution - 0014
Madrid, 28040
Local Institution - 0011
Madrid, 28050
Local Institution - 0015
Málaga, Andalusia, 29010
Local Institution - 0012
Pamplona, Navarre, 31008
United States4 sites
Local Institution - 0010
Hackensack, New Jersey, 07601
Local Institution - 0022
Lake Success, New York, 11042
Local Institution - 0021
Los Angeles, California, 90025
Local Institution - 0007
New Haven, Connecticut, 06510
Italy4 sites
Local Institution - 0026
Bergamo, 24127
Local Institution - 0025
Roma, 00168
Local Institution - 0023
Rozzano, Milano, 20089
Local Institution - 0024
Siena, Tuscany, 53100
France3 sites
Local Institution - 0003
Bordeaux, 33076
Local Institution - 0004
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
Local Institution - 0002
Villejuif, Paris, 94800
Belgium2 sites
Local Institution - 0016
Brussels, Bruxelles-Capitale, Région de, 1200
Local Institution - 0017
Ghent, Oost-Vlaanderen, 9000
Netherlands2 sites
Local Institution - 0030
Amsterdam, North Holland, 1066 CX
Local Institution - 0018
Groningen, 9713 GZ
About this study
Official title: A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986449, Nivolumab
- Keywords
- BMS-986449, Nivolumab, Cancer, Solid Tumors, Non-Small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC)
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986449Drug
Specified dose on specified days
NivolumabDrug
Also called OPDIVO®, BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: BMS-986449 monotherapy | Experimental | Not described Receives: Drug: BMS-986449 |
| Dose Escalation: BMS-986449 + nivolumab | Experimental | Not described Receives: Drug: BMS-986449; Drug: Nivolumab |
| Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts | Experimental | Not described Receives: Drug: BMS-986449 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose-Limiting Toxicities (DLTs)
Measured: Up to approximately 4 years
Number of participants with Adverse Events (AEs)
Measured: Up to approximately 4 years
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to approximately 4 years
Number of participants with AEs leading to discontinuation
Measured: Up to approximately 4 years
Number of deaths
Measured: Up to approximately 4 years
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax)
Measured: Up to approximately 4 years
Time of maximum observed concentration within a dosing interval (Tmax)
Measured: Up to approximately 4 years
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start6 Jun 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT05888831
- Sponsor's protocol ID
- CA120-1001
- Other IDs
- 2023-503484-42, U1111-1287-3575, 2023
- Status last verified
- Jun 2025
- First submitted
- 25 May 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05888831
- Acronym / sponsor ID
- CA120-1001
- Conditions
- Advanced Solid Tumors
- Keywords
- BMS-986449, Nivolumab, Cancer, Solid Tumors, Non-Small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Jun 2023 (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 and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: BMS-986449 monotherapy | Experimental | Drug: BMS-986449 |
| Dose Escalation: BMS-986449 + nivolumab | Experimental | Drug: BMS-986449, Drug: Nivolumab |
| Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts | Experimental | Drug: BMS-986449 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- Tumor biopsy must be obtained for all participants (unless medically precluded).
Key exclusion criteria (4 listed)
- History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
- Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- Other protocol-defined criteria may 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-986449Specified dose on specified days | Drug | Dose Escalation: BMS-986449 + nivolumab, Dose Escalation: BMS-986449 monotherapy, Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts |
| NivolumabAlso: OPDIVO®, BMS-936558Specified dose on specified days | Drug | Dose Escalation: BMS-986449 + nivolumab |
Primary outcome
Number of participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to approximately 4 years
Number of participants with Adverse Events (AEs)
Time frame: Up to approximately 4 years
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately 4 years
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 4 years
Number of deaths
Time frame: Up to approximately 4 years
3 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to approximately 4 years
Time of maximum observed concentration within a dosing interval (Tmax)
Time frame: Up to approximately 4 years
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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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
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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
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986449 and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 20 sites in 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, United States, Italy, France, Belgium and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
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 Dose-Limiting Toxicities (DLTs) (time frame: Up to approximately 4 years). The study lists 5 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 11 Jun 2025.