Advanced Solid CancersPhase 1NCT03956680
An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers
A Phase 1 study testing BMS-986301, Nivolumab and Ipilimumab in people with Advanced Solid Cancers, run by Bristol-Myers Squibb at 5 sites in 2 countries.
Trial summary
The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Cancers
- What is being tested?
- BMS-986301, Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 26 Mar 2019to 24 Apr 2024
- 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 unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- Must have experienced radiographically documented progressive disease on or after the most recent therapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Who cannot join
- Primary central nervous system (CNS) malignancy
- Other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Local Institution - 0003
Chicago, Illinois, 60637
Local Institution - 0002
Nashville, Tennessee, 37232
Local Institution - 0006
Pittsburgh, Pennsylvania, 15232-1305
Local Institution - 0005
St Louis, Missouri, 63110
About this study
Official title: A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.
- Conditions
- Advanced Solid Cancers
- Being tested
- BMS-986301, Nivolumab, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986301Drug
Specified dose on specified days
NivolumabBiological
Also called OPDIVO
Specified dose on specified days
IpilimumabBiological
Also called YERVOY
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) | Experimental | Not described Receives: Drug: BMS-986301; Biological: Nivolumab; Biological: Ipilimumab |
| Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study | Experimental | Not described Receives: Drug: BMS-986301; Biological: Nivolumab; Biological: Ipilimumab |
| Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study | Experimental | Not described Receives: Drug: BMS-986301; Biological: Nivolumab; Biological: Ipilimumab |
| Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab | Experimental | Not described Receives: Drug: BMS-986301; Biological: Nivolumab; Biological: Ipilimumab |
| Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab | Experimental | Not described Receives: Drug: BMS-986301; 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 toxicity (DLTs)
Measured: Cycle 1 (28 days)
Incidence of adverse events (AEs)
Measured: From Baseline until study exit (up to approximately 2 years)
Incidence of serious adverse events (SAEs)
Measured: From Baseline until study exit (up to approximately 2 years)
Incidence of AEs leading to discontinuation
Measured: From Baseline until study exit (up to approximately 2 years)
Incidence of deaths
Measured: From Baseline until study exit (up to approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: From Baseline until disease progression (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 posted21 May 2019
- Study start26 Mar 2019
- Primary completion17 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancersStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT03956680
- Sponsor's protocol ID
- CA046-006
- Other IDs
- 2018-003610-41, 2018
- Status last verified
- Feb 2025
- First submitted
- 23 Apr 2019
- Last updated
- 19 Feb 2025
- Results posted
- No
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT03956680
- Acronym / sponsor ID
- CA046-006
- Conditions
- Advanced Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 21 May 2019 (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 main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM) | Experimental | Drug: BMS-986301, Biological: Nivolumab, Biological: Ipilimumab |
| Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study | Experimental | Drug: BMS-986301, Biological: Nivolumab, Biological: Ipilimumab |
| Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study | Experimental | Drug: BMS-986301, Biological: Nivolumab, Biological: Ipilimumab |
| Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab | Experimental | Drug: BMS-986301, Biological: Nivolumab, Biological: Ipilimumab |
| Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab | Experimental | Drug: BMS-986301, Biological: Nivolumab, Biological: 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 unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- Must have experienced radiographically documented progressive disease on or after the most recent therapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Key exclusion criteria (4 listed)
- Primary central nervous system (CNS) malignancy
- 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-986301Specified dose on specified days | Drug | Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM), Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study, Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study, Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab, Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab |
| NivolumabAlso: OPDIVOSpecified dose on specified days | Biological | Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM), Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study, Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study, Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab, Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab |
| IpilimumabAlso: YERVOYSpecified dose on specified days | Biological | Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM), Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study, Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study, Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab, Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab |
Primary outcome
Incidence of dose-limiting toxicity (DLTs)
Time frame: Cycle 1 (28 days)
Incidence of adverse events (AEs)
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of serious adverse events (SAEs)
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of AEs leading to discontinuation
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of deaths
Time frame: From Baseline until study exit (up to approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: From Baseline until disease progression (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 19 Feb 2025.
- 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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986301, Nivolumab and Ipilimumab in people with Advanced Solid Cancers, run by Bristol-Myers Squibb at 5 sites in 2 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 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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?
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?
Incidence of dose-limiting toxicity (DLTs) (time frame: Cycle 1 (28 days)). The study lists 8 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 19 Feb 2025.