Advanced CancerPhase 1/2NCT03994601
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
A Phase 1/2 study testing BMS-986288, Nivolumab and Regorafenib in people with Advanced Cancer, run by Bristol-Myers Squibb at 40 sites in 7 countries.
Trial summary
The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- BMS-986288, Nivolumab and Regorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 40 sitesin 7 countries
- Study dates
- 6 Sep 2019to 31 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
- Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
Who cannot join
- Active, known or suspected autoimmune disease
- Active malignancy requiring concurrent intervention
- Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
Argentina8 sites
Local Institution - 0008
ABB, Distrito Federal, C1199
Local Institution - 0074
Buenos Aires, Buenos Aires F.D., C1096AAS
Local Institution - 0017
Buenos Aires, 1431
Local Institution - 0016
Buenos Aires, C1280AEB
Local Institution - 0012
CABA, Distrito Federal, C1430
Local Institution - 0011
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426
Local Institution - 0014
Córdoba, Córdoba Province, X5000HXL
Local Institution - 0013
Río Cuarto, Córdoba Province, 5800
United States6 sites
Local Institution - 0005
Aurora, Colorado, 80045
Local Institution - 0002
Baltimore, Maryland, 21287
Local Institution - 0075
Costa Mesa, California, 92627
Local Institution - 0001
Hackensack, New Jersey, 07601
Local Institution - 0050
Orange, California, 92868-3201
Local Institution - 0004
St Louis, Missouri, 63110
France6 sites
Local Institution - 0034
Bordeaux, Gironde, 33075
Local Institution - 0018
Bron, 69677
Local Institution - 0026
Marseille, 13915
Local Institution - 0015
Paris, 75248
Local Institution - 0022
Saint-Herblain, Loire-Atlantique, 44800
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, 83100
Italy6 sites
Local Institution - 0028
Ancona, 60126
Local Institution - 0033
Catanzaro, 88100
Local Institution - 0040
Milan, Lombardy, 20133
Local Institution - 0031
Milan, 20162
Local Institution - 0038
Padova, Veneto, 35128
Local Institution - 0039
Roma, 00168
Spain6 sites
Local Institution - 0056
Barcelona, Barcelona [Barcelona], 08035
Local Institution - 0054
Barcelona, Catalunya [Cataluña], 08036
Local Institution - 0023
Madrid, 28041
Local Institution - 0024
Majadahonda, 28222
Local Institution - 0055
Seville, 41013
Local Institution - 0025
Valencia, 46026
Chile5 sites
Local Institution - 0036
Santiago, Santiago Metropolitan, 7500921
Local Institution - 0019
Santiago, Santiago Metropolitan, 7510032
Local Institution - 0035
Santiago, Santiago Metropolitan, 7620002
Local Institution - 0009
Santiago, Santiago Metropolitan, 8420383
Local Institution - 0010
Viña del Mar, Valparaiso, 2520598
Canada3 sites
Local Institution - 0042
Montreal, Quebec, H2X 0A9
Local Institution - 0046
Montreal, Quebec, H3T 1E2
Local Institution - 0006
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
- Conditions
- Advanced Cancer
- Being tested
- BMS-986288, Nivolumab, Regorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986288Drug
Specified dose on specified days
NivolumabDrug
Also called Opdivo, BMS-936558
Specified dose on specified days
RegorafenibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BMS-986288 Monotherapy | Experimental | Not described Receives: Drug: BMS-986288 |
| Arm B: BMS-986288 in combination with Nivolumab | Experimental | Not described Receives: Drug: BMS-986288; Drug: Nivolumab |
| Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib | Experimental | Not described Receives: Drug: BMS-986288; Drug: Nivolumab; Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Related Events for Cohorts 1A, 1B and 2B.
Safety releated events for Cohorts 1A, 1B and 2B.
Measured: approximately 6 months
Dose Limiting Toxicities Cohorts 1A, 1B and 2B.
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
Measured: approximately 5 weeks
Objective Response Rate by BICR in Cohort 2C
The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.
Measured: approximately 2.15 Months
Secondary outcomes (17)
Objective Response Rate in Cohorts 1A, 1B and 2B
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
Measured: approximately 2.15 Months
Duration of Response in Cohorts 1A, 1B and 2B
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
Measured: approximately 2.15 Months
Time to Response in Cohorts 1A, 1B and 2B
Time to response (TTR) assessed by investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.
Measured: approximately 2.15 Months
Progression Free Survival in Cohorts 1A, 1B and 2B
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
Measured: approximately 2.15 Months
Duration of Response by BICR in Cohort 2C
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.
Measured: approximately 2.5 Months
PFS by BICR in Cohort 2C
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Measured: approximately 2.5 Months
Overall Survival in Cohort 2C
OS is defined as the time from randomization to the time of death due to any cause.
Measured: approximately 2.5 Months
Objective Response Rate by Investigator in Cohort 2C
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
Measured: approximately 2.5 Months
Duration of Response by Investigator in Cohort 2C
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
Measured: approximately 2.5 Months
PFS by Investigator in Cohort 2C
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
Measured: approximately 2.5 Months
Safety Related Events in Cohort 2C
Safety Related Events in Cohort 2C
Measured: approximately 6 Months
Dose Limiting Toxicities in Cohort 2C
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
Measured: approximately 5 weeks
Cmax for Cohorts 1A, 1B and 2B
Cmax is defined as maximum plasma concentration of the drug.
Measured: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Tmax for Cohorts 1A, 1B and 2B
Tmax is defined is the time to maximum plasma concentration
Measured: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(0-T) for Cohorts 1A, 1B and 2B
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration.
Measured: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(Tau) for Cohorts 1A, 1B and 2B
Area under the plasma concentration time-curve. AUC over the dosing interval.
Measured: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
C(Tau) for Cohorts 1A, 1B and 2B
Ctau is defined as the concentration of study drug at the end of the dosing interval
Measured: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start6 Sep 2019
- Primary completion31 Aug 2024
- Study completion31 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 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
- NCT03994601
- Sponsor's protocol ID
- CA043-001
- Other IDs
- 2021-004284-27
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2019
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT03994601
- Acronym / sponsor ID
- CA043-001
- Conditions
- Advanced Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Posted 20 Jan 2026
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 determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: BMS-986288 Monotherapy | Experimental | Drug: BMS-986288 |
| Arm B: BMS-986288 in combination with Nivolumab | Experimental | Drug: BMS-986288, Drug: Nivolumab |
| Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib | Experimental | Drug: BMS-986288, Drug: Nivolumab, Drug: Regorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
Key exclusion criteria (4 listed)
- Active, known or suspected autoimmune disease
- Active malignancy requiring concurrent intervention
- Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
- 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-986288Specified dose on specified days | Drug | Arm A: BMS-986288 Monotherapy, Arm B: BMS-986288 in combination with Nivolumab, Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Drug | Arm B: BMS-986288 in combination with Nivolumab, Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib |
| RegorafenibSpecified dose on specified days | Drug | Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib |
Primary outcome
Safety Related Events for Cohorts 1A, 1B and 2B.
Time frame: approximately 6 months
Safety releated events for Cohorts 1A, 1B and 2B.
Dose Limiting Toxicities Cohorts 1A, 1B and 2B.
Time frame: approximately 5 weeks
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
Objective Response Rate by BICR in Cohort 2C
Time frame: approximately 2.15 Months
The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.
17 secondary outcomes
Objective Response Rate in Cohorts 1A, 1B and 2B
Time frame: approximately 2.15 Months
Duration of Response in Cohorts 1A, 1B and 2B
Time frame: approximately 2.15 Months
Time to Response in Cohorts 1A, 1B and 2B
Time frame: approximately 2.15 Months
Progression Free Survival in Cohorts 1A, 1B and 2B
Time frame: approximately 2.15 Months
Duration of Response by BICR in Cohort 2C
Time frame: approximately 2.5 Months
PFS by BICR in Cohort 2C
Time frame: approximately 2.5 Months
Overall Survival in Cohort 2C
Time frame: approximately 2.5 Months
Objective Response Rate by Investigator in Cohort 2C
Time frame: approximately 2.5 Months
Duration of Response by Investigator in Cohort 2C
Time frame: approximately 2.5 Months
PFS by Investigator in Cohort 2C
Time frame: approximately 2.5 Months
Safety Related Events in Cohort 2C
Time frame: approximately 6 Months
Dose Limiting Toxicities in Cohort 2C
Time frame: approximately 5 weeks
Cmax for Cohorts 1A, 1B and 2B
Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Tmax for Cohorts 1A, 1B and 2B
Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(0-T) for Cohorts 1A, 1B and 2B
Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(Tau) for Cohorts 1A, 1B and 2B
Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
C(Tau) for Cohorts 1A, 1B and 2B
Time frame: On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- 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.
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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
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986288, Nivolumab and Regorafenib in people with Advanced Cancer, run by Bristol-Myers Squibb at 40 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 3 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Argentina, United States, France, Italy, Spain 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 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 20 Jan 2026). 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?
Safety Related Events for Cohorts 1A, 1B and 2B. (time frame: approximately 6 months). The study lists 3 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 20 Jan 2026.