Advanced Solid TumorsPhase 1NCT06544655
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1 study testing BMS-986484, Nivolumab and Oxaliplatin in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 9 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma… 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-986484, Nivolumab and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 10 Oct 2024to 14 Oct 2027
- Phase
- Phase 1
- 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
- Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
- Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
- Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Who cannot join
- History of or with active interstitial lung disease or pulmonary fibrosis.
- Active, known, or suspected autoimmune disease.
- Serious uncontrolled medical disorders.
- New onset, non-catheter-associated venous thromboembolism within the past 6 months.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States5 sites
Local Institution - 0011
Grand Rapids, Michigan, 49546
Local Institution - 0007
Los Angeles, California, 90033
Local Institution - 0013
San Antonio, Texas, 78229
Local Institution - 0004
Sioux Falls, South Dakota, 57104
Local Institution - 0003
Tucson, Arizona, 85719
Australia2 sites
Local Institution - 0021
Darlinghurst, New South Wales, 2010
Local Institution - 0019
Elizabeth Vale, South Australia, 5112
Canada2 sites
Local Institution - 0016
Montreal, Quebec, H2X 0A9
Local Institution - 0017
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986484, Nivolumab, Oxaliplatin, Capecitabine, Fluorouracil
- Keywords
- Opdivo®, Immunotherapy, BMS-986484, Non-small cell lung cancer (NSCLC), Microsatellite stable (MSS) colorectal carcinoma (CRC), Pancreatic ductal adenocarcinoma (PDAC), Gastric/gastroesophageal junction adenocarcinoma (G/GEJC), Squamous cell carcinoma of the head and neck (SCCHN), anti-CD40, anti-FAP, FOLFOX, CAPOX, Chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Spinocerebellar Degenerations, Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986484Drug
Specified dose on specified days
NivolumabBiological
Also called Opdivo
Specified dose on specified days
OxaliplatinDrug
Specified dose on specified days
CapecitabineDrug
Specified dose on specified days
FluorouracilDrug
Specified dose on specified days
Calcium folinateDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: BMS-986484 Dose Escalation | Experimental | Not described Receives: Drug: BMS-986484 |
| Part 1B: BMS-986484 + Nivolumab Dose Escalation | Experimental | Not described Receives: Drug: BMS-986484; Biological: Nivolumab |
| Part 2A: BMS-986484 Dose Expansion | Experimental | Not described Receives: Drug: BMS-986484 |
| Part 2B: BMS-986484 + Nivolumab Dose Expansion | Experimental | Not described Receives: Drug: BMS-986484; Biological: Nivolumab |
| Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation | Experimental | Not described Receives: Drug: BMS-986484; Biological: Nivolumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Fluorouracil; Drug: Calcium folinate |
| Part 1 Co-Admin: BMS-986484 + Nivolumab | Experimental | Not described Receives: Drug: BMS-986484; Biological: Nivolumab |
| Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation | Experimental | Not described Receives: Drug: BMS-986484 |
| Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion | Experimental | Not described Receives: Drug: BMS-986484; Biological: Nivolumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Fluorouracil; Drug: Calcium folinate |
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 approximately 2 years
Incidence of serious adverse events (SAEs)
Measured: Up to approximately 2 years
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Measured: Up to approximately 28 days
Incidence of AEs leading to discontinuation
Measured: Up to approximately 2 years
Incidence of AEs leading to death
Measured: Up to approximately 2 years
Secondary outcomes (7)
Maximum observed concentration (Cmax)
Measured: Up to approximately 2 years
Time of maximum observed concentration (Tmax)
Measured: Up to approximately 2 years
Area under the concentration-time curve (AUC)
Measured: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs)
Measured: Up to approximately 2 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Up to approximately 2 years
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Up to approximately 2 years
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 Oct 2024
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2027 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 213 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
- NCT06544655
- Sponsor's protocol ID
- CA233-0000
- Other IDs
- EU 2024-513696-40
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2024
- Last updated
- 17 Apr 2026
- 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT06544655
- Acronym / sponsor ID
- CA233-0000
- Conditions
- Advanced Solid Tumors
- Keywords
- Opdivo®, Immunotherapy, BMS-986484, Non-small cell lung cancer (NSCLC), Microsatellite stable (MSS) colorectal carcinoma (CRC), Pancreatic ductal adenocarcinoma (PDAC), Gastric/gastroesophageal junction adenocarcinoma (G/GEJC), Squamous cell carcinoma of the head and neck (SCCHN)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2027 (estimated)
- First posted
- 9 Aug 2024 (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 assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1A: BMS-986484 Dose Escalation | Experimental | Drug: BMS-986484 |
| Part 1B: BMS-986484 + Nivolumab Dose Escalation | Experimental | Drug: BMS-986484, Biological: Nivolumab |
| Part 2A: BMS-986484 Dose Expansion | Experimental | Drug: BMS-986484 |
| Part 2B: BMS-986484 + Nivolumab Dose Expansion | Experimental | Drug: BMS-986484, Biological: Nivolumab |
| Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation | Experimental | Drug: BMS-986484, Biological: Nivolumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Fluorouracil, Drug: Calcium folinate |
| Part 1 Co-Admin: BMS-986484 + Nivolumab | Experimental | Drug: BMS-986484, Biological: Nivolumab |
| Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation | Experimental | Drug: BMS-986484 |
| Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion | Experimental | Drug: BMS-986484, Biological: Nivolumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Fluorouracil, Drug: Calcium folinate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
- Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
- Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Key exclusion criteria (5 listed)
- History of or with active interstitial lung disease or pulmonary fibrosis.
- Active, known, or suspected autoimmune disease.
- Serious uncontrolled medical disorders.
- New onset, non-catheter-associated venous thromboembolism within the past 6 months.
- 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-986484Specified dose on specified days | Drug | Part 1 Co-Admin: BMS-986484 + Nivolumab, Part 1A: BMS-986484 Dose Escalation, Part 1B: BMS-986484 + Nivolumab Dose Escalation, Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation, Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation, Part 2A: BMS-986484 Dose Expansion, Part 2B: BMS-986484 + Nivolumab Dose Expansion, Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion |
| NivolumabAlso: OpdivoSpecified dose on specified days | Biological | Part 1 Co-Admin: BMS-986484 + Nivolumab, Part 1B: BMS-986484 + Nivolumab Dose Escalation, Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation, Part 2B: BMS-986484 + Nivolumab Dose Expansion, Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion |
| OxaliplatinSpecified dose on specified days | Drug | Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation, Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion |
| CapecitabineSpecified dose on specified days | Drug | Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation, Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion |
| FluorouracilSpecified dose on specified days | Drug | Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation, Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion |
| Calcium folinateSpecified dose on specified days | Drug | Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation, Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to approximately 2 years
Incidence of serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time frame: Up to approximately 28 days
Incidence of AEs leading to discontinuation
Time frame: Up to approximately 2 years
Incidence of AEs leading to death
Time frame: Up to approximately 2 years
7 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to approximately 2 years
Time of maximum observed concentration (Tmax)
Time frame: Up to approximately 2 years
Area under the concentration-time curve (AUC)
Time frame: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs)
Time frame: Up to approximately 2 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 2 years
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 2 years
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 2 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 17 Apr 2026.
- 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986484, Nivolumab and Oxaliplatin in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 9 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 3 inclusion and 5 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia, Canada. 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?
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?
Incidence of adverse events (AEs) (time frame: Up to approximately 2 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 17 Apr 2026.