Advanced Solid TumorsPhase 1NCT05625412
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
A Phase 1 study testing BMS-986360, Docetaxel and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 35 sites in 9 countries.
Trial summary
The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or 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-986360, Docetaxel and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 35 sitesin 9 countries
- Study dates
- 9 Dec 2022to 12 May 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 in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible.
- In Part 2, archival biopsy collected within 3 months of screening with no intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) or fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at progression. Therefore, the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure, as judged by the investigator, in order to be eligible for the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit (in addition, participants with NSCLC must be resistant or refractory to anti-PD-(L)1-based immunotherapy)
Who cannot join
- Participants with primary central nervous system (CNS) disease, or tumors with CNS metastases as the only disease site, will be excluded. Participants with controlled brain metastases, however, will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), no longer taking steroids for at least 2 weeks prior to first dose of study intervention, and with no new or progressive neurological signs and symptoms.
- Participants with a condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer or non-invasive or in situ cancers who have undergone definitive treatment) are excluded unless treatment was completed at least 2 years before randomization and the participant has no evidence of disease.
- Participants with NSCLC with known or not tested for epidermal growth factor receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations sensitive to available targeted inhibitor therapy
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
35 sites in 9 countries.
35 sites in 9 countries
United States8 sites
Local Institution - 0001
Hackensack, New Jersey, 07601
Local Institution - 0018
Huntersville, North Carolina, 28078
Local Institution - 0029
Los Angeles, California, 90025
Local Institution - 0051
Los Angeles, California, 90067
Local Institution - 0028
Nashville, Tennessee, 37203
Local Institution - 0026
New Orleans, Louisiana, 70121
Local Institution - 0027
San Antonio, Texas, 78229
Local Institution - 0046
West Valley City, Utah, 84119
Australia4 sites
Local Institution - 0008
Brisbane, Queensland, 4120
Local Institution - 0010
Darlinghurst, New South Wales, 2010
Local Institution - 0063
Frankston, Victoria, 3199
Local Institution - 0061
St Leonards, New South Wales, 2065
France4 sites
Local Institution - 0049
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
Local Institution - 0048
Paris, 75248
Local Institution - 0050
Toulouse, 31059
Local Institution - 0052
Villejuif, Val-de-Marne, 94800
Mexico4 sites
Local Institution - 0038
Mexico City, Mexico City, 03100
Local Institution - 0039
Monterrey, Nuevo León, 66460
Local Institution - 0037
Puebla City, 72424
Local Institution - 0041
Zapopan, Jalisco, 45070
Spain4 sites
Local Institution - 0053
Barcelona, Catalunya [Cataluña], 08036
Local Institution - 0055
Madrid, Madrid, Comunidad de, 28034
Local Institution - 0056
Madrid, Madrid, Comunidad de, 28041
Local Institution - 0064
Seville, 41013
Argentina3 sites
Local Institution - 0031
Buenos Aires, 1426
Local Institution - 0030
CABA, Buenos Aires F.D., C1430EGF
Local Institution - 0033
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280
Chile3 sites
Local Institution - 0047
Santiago, Santiago Metropolitan, 7500921
Local Institution - 0035
Santiago, Santiago Metropolitan, 8330032
Local Institution - 0034
Santiago, Santiago Metropolitan, 8420383
Italy3 sites
Local Institution - 0059
Candiolo, Torino, 10060
Local Institution - 0065
Padova, 35128
Local Institution - 0057
Rozzano, Milano, 20089
Canada2 sites
Local Institution - 0003
Ottawa, Ontario, K1H 8L6
Local Institution - 0005
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986360, Docetaxel, Nivolumab, Capecitabine
- Keywords
- Solid tumors, Nivolumab, Chemotherapy, BMS-986360, CC-90001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986360Drug
Also called CC-90001
Specified dose on specified days
DocetaxelDrug
Also called Taxotere®
Specified dose on specified days
NivolumabDrug
Also called Opdivo®, BMS-936558
Specified dose on specified days
CapecitabineDrug
Also called Xeloda®
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986360 | Experimental | Not described Receives: Drug: BMS-986360 |
| BMS-986360 + Docetaxel | Experimental | Not described Receives: Drug: BMS-986360; Drug: Docetaxel |
| BMS-986360 + Nivolumab | Experimental | Not described Receives: Drug: BMS-986360; Drug: Nivolumab |
| BMS-986360 + Capecitabine | Experimental | Not described Receives: Drug: BMS-986360; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Measured: Up to approximately 2 years
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to approximately 2 years
Number of participants with Dose-Limiting Toxicities (DLTs)
Measured: Up to approximately 2 years
Number of participants with AEs leading to discontinuation
Measured: Up to approximately 2 years
Number of deaths
Measured: Up to approximately 2 years
Secondary outcomes (7)
Maximum observed plasma concentration (Cmax)
Measured: Up to approximately 2 years
Time of maximum observed plasma concentration (Tmax)
Measured: Up to approximately 2 years
Area under the plasma concentration-time curve (AUC)
Measured: Up to approximately 2 years
Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator
Measured: Up to approximately 2 years
Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment
Measured: Up to approximately 2 years
Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator
Measured: Up to approximately 2 years
Part 2: DOR based on RECIST v1.1 by BICR assessment
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 posted22 Nov 2022
- Study start9 Dec 2022
- Primary completion12 May 2025
- Study completion12 May 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT05625412
- Sponsor's protocol ID
- IM043-004
- Other IDs
- 2022-500930-27
- Status last verified
- Jun 2025
- First submitted
- 15 Nov 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05625412
- Acronym / sponsor ID
- IM043-004
- Conditions
- Advanced Solid Tumors
- Keywords
- Solid tumors, Nivolumab, Chemotherapy, BMS-986360, CC-90001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 22 Nov 2022 (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 aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-986360 | Experimental | Drug: BMS-986360 |
| BMS-986360 + Docetaxel | Experimental | Drug: BMS-986360, Drug: Docetaxel |
| BMS-986360 + Nivolumab | Experimental | Drug: BMS-986360, Drug: Nivolumab |
| BMS-986360 + Capecitabine | Experimental | Drug: BMS-986360, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible.
- In Part 2, archival biopsy collected within 3 months of screening with no intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) or fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at progression. Therefore, the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure, as judged by the investigator, in order to be eligible for the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit (in addition, participants with NSCLC must be resistant or refractory to anti-PD-(L)1-based immunotherapy)
Key exclusion criteria (5 listed)
- Participants with primary central nervous system (CNS) disease, or tumors with CNS metastases as the only disease site, will be excluded. Participants with controlled brain metastases, however, will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), no longer taking steroids for at least 2 weeks prior to first dose of study intervention, and with no new or progressive neurological signs and symptoms.
- Participants with a condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer or non-invasive or in situ cancers who have undergone definitive treatment) are excluded unless treatment was completed at least 2 years before randomization and the participant has no evidence of disease.
- Participants with NSCLC with known or not tested for epidermal growth factor receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations sensitive to available targeted inhibitor therapy
- 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-986360Also: CC-90001Specified dose on specified days | Drug | BMS-986360, BMS-986360 + Capecitabine, BMS-986360 + Docetaxel, BMS-986360 + Nivolumab |
| DocetaxelAlso: Taxotere®Specified dose on specified days | Drug | BMS-986360 + Docetaxel |
| NivolumabAlso: Opdivo®, BMS-936558Specified dose on specified days | Drug | BMS-986360 + Nivolumab |
| CapecitabineAlso: Xeloda®Specified dose on specified days | Drug | BMS-986360 + Capecitabine |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately 2 years
Number of participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to approximately 2 years
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2 years
Number of deaths
Time frame: Up to approximately 2 years
7 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to approximately 2 years
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to approximately 2 years
Area under the plasma concentration-time curve (AUC)
Time frame: Up to approximately 2 years
Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator
Time frame: Up to approximately 2 years
Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment
Time frame: Up to approximately 2 years
Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator
Time frame: Up to approximately 2 years
Part 2: DOR based on RECIST v1.1 by BICR assessment
Time frame: Up to approximately 2 years
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 13 Jun 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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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
35 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986360, Docetaxel and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 35 sites in 9 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 4 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: finished, as of the sponsor's last update on 13 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 35 sites in United States, Australia, France, Mexico, Spain and 4 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?
Number of participants with 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 13 Jun 2025.