Advanced CancerPhase 1NCT03444753
An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
A Phase 1 study testing BMS-986299, Nivolumab and Ipilimumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 9 sites in United States.
Trial summary
The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated. 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-986299, Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Apr 2018to 14 Feb 2022
- 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
- Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- IO therapy resistant or insensitive tumors
- Have at least 2 tumor lesions accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Who cannot join
- Primary CNS malignancy
- Participants with other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Local Institution
Detroit, Michigan, 48202
MD Anderson Cancer Center
Houston, Texas, 77030
Local Institution - 0003
La Jolla, California, 92093-0698
Local Institution
New Haven, Connecticut, 06520
Local Institution
Orange, California, 92868
Local Institution
Pittsburgh, Pennsylvania, 15232-1305
Local Institution
Portland, Oregon, 97239
University of California Davis Medical Center
Sacramento, California, 95817
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.
- Conditions
- Advanced Cancer
- Being tested
- BMS-986299, Nivolumab, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986299Drug
Specified dose on specified day
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified day
IpilimumabBiological
Also called Yervoy, BMS-734016
Specified dose on specified day
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | BMS-986299 Receives: Drug: BMS-986299 |
| Arm B | Experimental | BMS-986299 in combination with nivolumab and ipilimumab Receives: Drug: BMS-986299; Biological: Nivolumab; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: Up to 28 days
Incidence of adverse events (AEs)
Measured: Approximately 2 years
Incidence of clinical laboratory abnormalities
Measured: Approximately 2 years
Incidence of serious adverse events (SAEs)
Measured: Approximately 2 years
Incidence of AEs leading to discontinuation and deaths
Measured: Approximately 2 years
Secondary outcomes (4)
Maximum observed plasma concentration (Cmax)
Measured: Approximately 2 years
Time of maximum observed plasma concentration (Tmax)
Measured: Approximately 2 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Approximately 2 years
Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]
Measured: 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 posted23 Feb 2018
- Study start5 Apr 2018
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Why it stopped: business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT03444753
- Sponsor's protocol ID
- CA039-001
- Status last verified
- May 2022
- First submitted
- 20 Feb 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nelson BE, O'Brien S, Sheth RA, Hong DS, Naing A, Zhang X, Xu A, Hamuro L, Suryawanshi R, McKinley D, Novosiadly RD, Piha-Paul SA. Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors. J Immunother Cancer. 2025 Jan 16;13(1):e010013. doi: 10.1136/jitc-2024-010013.
PubMed 39824531
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT03444753
- Acronym / sponsor ID
- CA039-001
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business objectives have changed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 23 Feb 2018 (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 determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BMS-986299BMS-986299 |
| Arm B | Experimental | Drug: BMS-986299, Biological: Nivolumab, Biological: IpilimumabBMS-986299 in combination with nivolumab and ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- IO therapy resistant or insensitive tumors
- Have at least 2 tumor lesions accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Key exclusion criteria (4 listed)
- Primary CNS malignancy
- Participants with other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease
- 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-986299Specified dose on specified day | Drug | Arm A, Arm B |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified day | Biological | Arm B |
| IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified day | Biological | Arm B |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Incidence of adverse events (AEs)
Time frame: Approximately 2 years
Incidence of clinical laboratory abnormalities
Time frame: Approximately 2 years
Incidence of serious adverse events (SAEs)
Time frame: Approximately 2 years
Incidence of AEs leading to discontinuation and deaths
Time frame: Approximately 2 years
4 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Approximately 2 years
Time of maximum observed plasma concentration (Tmax)
Time frame: Approximately 2 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Approximately 2 years
Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]
Time frame: Approximately 2 years
Results and safety
The study was stopped early (reason given: business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 39824531Nelson BE, O'Brien S, Sheth RA, Hong DS, Naing A, Zhang X, Xu A, Hamuro L, Suryawanshi R, McKinley D, Novosiadly RD, Piha-Paul SA. Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors. J Immunother Cancer. 2025 Jan 16;13(1):e010013. doi: 10.1136/jitc-2024-010013.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986299, Nivolumab and Ipilimumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 9 sites in United States.
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 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: stopped early, as of the sponsor's last update on 23 May 2022. 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. 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 was stopped early (reason given: business objectives have changed). Results are not available in the source record.
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 dose-limiting toxicities (DLTs) (time frame: Up to 28 days). 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?
On the ClinicalTrials.gov record for NCT03444753, which also lists 1 linked publication.
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 23 May 2022.