Advanced CancerPhase 1NCT05298592
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
A Phase 1 study testing BMS-986406, Nivolumab and Carboplatin in people with Advanced Cancer, run by Bristol-Myers Squibb at 29 sites in 6 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced 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-986406, Nivolumab and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 31 Mar 2022to 16 Aug 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
- Parts 1A, 1B, 1C:
- Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
- Part 1D:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.
- All Parts:
- Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate organ function
Who cannot join
- Prior organ or tissue allograft
- Leptomeningeal metastases
- Untreated CNS metastases
- Serious or uncontrolled medical disorders
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
United States9 sites
Local Institution - 0021
Birmingham, Alabama, 35213
Mary Crowley Cancer Research - Medical City Hospital
Dallas, Texas, 75230
Local Institution - 0001
Hackensack, New Jersey, 07601
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, 28078
University California San Diego Moores Cancer Center
La Jolla, California, 92093
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025
UCLA Health
Los Angeles, California, 90404
Local Institution - 0006
Richmond, Virginia, 23298
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Spain8 sites
Local Institution - 0030
Barcelona, 08023
Local Institution - 0017
Barcelona, 08035
Institut Catala dOncologia ICO - Hospital Duran i Reynals Location
Barcelona, 08908
Local Institution - 0014
Madrid, 28027
Local Institution - 0009
Madrid, 28041
Local Institution - 0016
Madrid, 28050
Local Institution - 0008
Málaga, Andaluca, 29010
Local Institution - 0033
Pamplona, 31008
Argentina4 sites
Local Institution - 0028
Buenos Aires, C1280
Local Institution - 0032
Córdoba, 5002
Local Institution - 0023
Rosario, Santa Fe Province, 2000
Local Institution - 0029
Viedma, Río Negro Province, 8500
South Korea4 sites
Local Institution - 0026
Seongnam-si, Gyeonggi-do, 13620
Local Institution - 0024
Seoul, 3080
Local Institution - 0027
Seoul, 3722
Local Institution - 0025
Seoul, 6351
Belgium3 sites
Local Institution - 0012
Brussels, 1200
Local Institution - 0015
Edegem, MA, 2650
Local Institution - 0018
Jette, Brussels Capital, 1090
About this study
Official title: A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors
The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.
- Conditions
- Advanced Cancer
- Being tested
- BMS-986406, Nivolumab, Carboplatin, Pemetrexed, Paclitaxel
- Keywords
- Opdivo®, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986406Biological
Specified dose on specified days
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: BMS-986406 (Monotherapy Dose Escalation) | Experimental | Not described Receives: Biological: BMS-986406 |
| Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation) | Experimental | Not described Receives: Biological: BMS-986406; Biological: Nivolumab |
| Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion) | Experimental | Not described Receives: Biological: BMS-986406; Biological: Nivolumab |
| Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) | Experimental | Not described Receives: Biological: BMS-986406; Biological: Nivolumab |
| Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel | Experimental | Not described Receives: Biological: BMS-986406; Biological: Nivolumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel |
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 100 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 100 days
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Measured: Up to 28 days
Number of participants with AEs leading to discontinuation
Measured: Up to 100 days
Number of participants with death
Measured: Up to 100 days
Secondary outcomes (9)
Maximum observed plasma concentration (Cmax)
Measured: Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 14 days
Trough observed plasma concentration (Ctrough)
Measured: Up to 14 days
Incidence of anti-drug antibody (ADAs)
Measured: Up to 14 days
Objective response rate (ORR)
Measured: Up to 24 months
Disease control rate (DCR)
Measured: Up to 24 months
Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma
Measured: Up to 24 months
DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
Measured: Up to 24 months
DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start31 Mar 2022
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 77 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
- NCT05298592
- Sponsor's protocol ID
- CA111-001
- Other IDs
- 2021-006872-17, U1111-1270-3670
- Status last verified
- Sep 2024
- First submitted
- 17 Mar 2022
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05298592
- Acronym / sponsor ID
- CA111-001
- Conditions
- Advanced Cancer
- Keywords
- Opdivo®, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 28 Mar 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 purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1A: BMS-986406 (Monotherapy Dose Escalation) | Experimental | Biological: BMS-986406 |
| Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation) | Experimental | Biological: BMS-986406, Biological: Nivolumab |
| Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion) | Experimental | Biological: BMS-986406, Biological: Nivolumab |
| Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) | Experimental | Biological: BMS-986406, Biological: Nivolumab |
| Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel | Experimental | Biological: BMS-986406, Biological: Nivolumab, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.
- Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate organ function
Key exclusion criteria (5 listed)
- Prior organ or tissue allograft
- Leptomeningeal metastases
- Untreated CNS metastases
- Serious or uncontrolled medical disorders
- 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-986406Specified dose on specified days | Biological | Part 1A: BMS-986406 (Monotherapy Dose Escalation), Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation), Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion), Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel, Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) |
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Biological | Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation), Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion), Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel, Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) |
| CarboplatinSpecified dose on specified days | Drug | Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel |
| PemetrexedSpecified dose on specified days | Drug | Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel |
| PaclitaxelSpecified dose on specified days | Drug | Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 100 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 100 days
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time frame: Up to 28 days
Number of participants with AEs leading to discontinuation
Time frame: Up to 100 days
Number of participants with death
Time frame: Up to 100 days
9 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 14 days
Trough observed plasma concentration (Ctrough)
Time frame: Up to 14 days
Incidence of anti-drug antibody (ADAs)
Time frame: Up to 14 days
Objective response rate (ORR)
Time frame: Up to 24 months
Disease control rate (DCR)
Time frame: Up to 24 months
Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma
Time frame: Up to 24 months
DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
Time frame: Up to 24 months
DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types
Time frame: Up to 24 months
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 26 Sep 2024.
- 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
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986406, Nivolumab and Carboplatin in people with Advanced Cancer, run by Bristol-Myers Squibb at 29 sites in 6 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 8 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Spain, Argentina, South Korea, Belgium and 1 more country. 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 100 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?
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 26 Sep 2024.