Advanced CancerPhase 1NCT03661632
An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors
A Phase 1 study testing BMS-986310 and Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 7 sites in 3 countries.
Trial summary
The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing. 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-986310 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 11 Sep 2018to 29 Dec 2020
- 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
- Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy.
- ECOG performance status less than or equal to 1
- Part 1 and Sub-study B:
- Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible.
- Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, in one of the following tumor types: Renal cell carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High (determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing methodology must be provided), Bladder cancer, Squamous Cell Carcinoma of the Head and Neck (SCCHN), and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy
- Sub-study A:
- Participants must be newly diagnosed, no prior history of treatment for bladder cancer ii) Participants must not meet criteria for standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of primary tumor.
- Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure or mixed histology urothelial carcinoma Part 2 - Patients with relapsed / refractory solid tumors where no other standard of care treatment option is available.
Who cannot join
- History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors.
- Participants with an active, known or suspected autoimmune disease.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.
- Conditions
- Advanced Cancer
- Being tested
- BMS-986310, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986310Drug
Specified dose on specified days
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Part 1: BMS-986310 + Nivolumab Combination Dose Escalation
Sub-Study A: A cohort of Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy.
Sub-Study B: A cohort of PD[L]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab Receives: Drug: BMS-986310; Biological: Nivolumab |
| Cohort Expansion | Experimental | Part 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1.
BMS-986310 + Nivolumab combination will be administered in specific patient populations. Receives: Drug: BMS-986310; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AE)
Measured: up to 3 years
Incidence of Serious Adverse Events (SAE)
Measured: up to 3 years
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Measured: up to 3 years
Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)
Measured: up to 3 years
Incidence of Laboratory abnormalities
Measured: up to 3 years
Incidence of death
Measured: up to 3 years
Secondary outcomes (14)
Objective response rate (ORR)
Measured: up to 3 years
Median duration of response (mDOR)
Measured: up to 3 years
Progression free survival rate (PFSR)
Measured: up to 24 months
Maximum observed serum concentration (Cmax)
Measured: up to 3 years
Observed serum concentration at the end of a dosing interval (Ctau)
Measured: up to 3 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: up to 3 years
Apparent total body clearance (CLT/F)
Measured: up to 3 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Measured: up to 3 years
AUC accumulation index (AI_AUC)
Measured: up to 3 years
Cmax accumulation index (AI_Cmax)
Measured: up to 3 years
Summary changes of prostaglandin E metabolite (PGEM) in urine
Measured: up to 3 years
Summary changes of tumor necrosis factor (TNFa) in blood
Measured: up to 3 years
Summary of PK parameters at T-HALF
Measured: up to 3 years
Summary of PK parameter AUC(INF) after single dose
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start11 Sep 2018
- Primary completion11 Nov 2019
- Study completion29 Dec 2020
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
- 27 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
- NCT03661632
- Sponsor's protocol ID
- CA044-001
- Other IDs
- 2018-002108-15, 2018
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2018
- Last updated
- 8 Nov 2021
- 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 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03661632
- Acronym / sponsor ID
- CA044-001
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 7 Sep 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 if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: BMS-986310, Biological: NivolumabPart 1: BMS-986310 + Nivolumab Combination Dose Escalation Sub-Study A: A cohort of Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy. Sub-Study B: A cohort of PD[L]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab |
| Cohort Expansion | Experimental | Drug: BMS-986310, Biological: NivolumabPart 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1. BMS-986310 + Nivolumab combination will be administered in specific patient populations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy.
- ECOG performance status less than or equal to 1
- Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible.
- Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, in one of the following tumor types: Renal cell carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High (determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing methodology must be provided), Bladder cancer, Squamous Cell Carcinoma of the Head and Neck (SCCHN), and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy
- Participants must be newly diagnosed, no prior history of treatment for bladder cancer ii) Participants must not meet criteria for standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of primary tumor.
Key exclusion criteria (3 listed)
- History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) or Cyclooxygenase-2 (COX-2) inhibitors.
- Participants with an active, known or suspected autoimmune disease.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
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-986310Specified dose on specified days | Drug | Cohort Expansion, Dose Escalation |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Biological | Cohort Expansion, Dose Escalation |
Primary outcome
Incidence of Adverse Events (AE)
Time frame: up to 3 years
Incidence of Serious Adverse Events (SAE)
Time frame: up to 3 years
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: up to 3 years
Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)
Time frame: up to 3 years
Incidence of Laboratory abnormalities
Time frame: up to 3 years
Incidence of death
Time frame: up to 3 years
14 secondary outcomes
Objective response rate (ORR)
Time frame: up to 3 years
Median duration of response (mDOR)
Time frame: up to 3 years
Progression free survival rate (PFSR)
Time frame: up to 24 months
Maximum observed serum concentration (Cmax)
Time frame: up to 3 years
Observed serum concentration at the end of a dosing interval (Ctau)
Time frame: up to 3 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: up to 3 years
Apparent total body clearance (CLT/F)
Time frame: up to 3 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time frame: up to 3 years
AUC accumulation index (AI_AUC)
Time frame: up to 3 years
Cmax accumulation index (AI_Cmax)
Time frame: up to 3 years
Summary changes of prostaglandin E metabolite (PGEM) in urine
Time frame: up to 3 years
Summary changes of tumor necrosis factor (TNFa) in blood
Time frame: up to 3 years
Summary of PK parameters at T-HALF
Time frame: up to 3 years
Summary of PK parameter AUC(INF) after single dose
Time frame: up to 3 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 8 Nov 2021.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986310 and Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 7 sites in 3 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 3 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 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Belgium, 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 Adverse Events (AE) (time frame: up to 3 years). The study lists 6 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 8 Nov 2021.