Malignant Solid TumorPhase 1/2NCT02754141

An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

A Phase 1/2 study testing BMS-986179, Nivolumab and rHuPH20 in people with Malignant Solid Tumor, run by Bristol-Myers Squibb at 24 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Solid Tumor
What is being tested?: BMS-986179, Nivolumab and rHuPH20
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 235 participants
Where: 24 sitesin 7 countries
Study dates: 21 Jun 2016to 12 Oct 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
Eastern Cooperative Oncology Group (ECOG) 0-1
Acceptable lab testing results
Allow biopsies

Who cannot join

Central nervous system (CNS) tumors
Uncontrolled or significant cardiovascular diseases
Active or known autoimmune disease
Organ transplant
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

24 sites in 7 countries.

Country

City, postcode or hospital

24 sites in 7 countries

United States8 sites

Local Institution - 0001
Baltimore, Maryland, 21287
Local Institution - 0022
Boston, Massachusetts, 02215
Local Institution - 0023
Buffalo, New York, 14263
Local Institution - 0028
Chicago, Illinois, 60611
Local Institution - 0009
Dallas, Texas, 75230
Local Institution - 0004
Nashville, Tennessee, 37203
Local Institution - 0005
New York, New York, 10032
Local Institution - 0020
Pittsburgh, Pennsylvania, 15232

Other trials in United States

Canada4 sites

Local Institution - 0024
Montreal, Quebec, H2X 3E4
Local Institution - 0014
Montreal, Quebec, H3T 1E2
Local Institution - 0003
Ottawa, Ontario, K1H 8L6
Local Institution - 0002
Toronto, Ontario, M5G 1Z5

Other trials in Canada

France4 sites

Local Institution - 0033
Marseille, 13273
Local Institution - 0021
Marseille, 13385
Local Institution - 0008
Toulouse, 31059
Local Institution - 0007
Villejuif, 94805

Other trials in France

Australia3 sites

Local Institution - 0018
Melbourne, Victoria, 3004
Local Institution - 0019
Randwick, New South Wales, 2031
Local Institution - 0017
Sydney, New South Wales, 2010

Other trials in Australia

Germany2 sites

Local Institution - 0016
Freiburg im Breisgau, 79106
Local Institution - 0015
Munich, 81675

Other trials in Germany

Italy2 sites

Local Institution - 0012
Naples, 80131
Local Institution - 0013
Padova, Padova

Other trials in Italy

Netherlands1 site

Local Institution - 0006
Amsterdam, 1066 CX

Other trials in Netherlands

About this study

Official title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

Conditions: Malignant Solid Tumor
Being tested: BMS-986179, Nivolumab, rHuPH20

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986179Biological
Specified dose on specified days
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days
rHuPH20Biological
Specified dose on specified days

Study groups in NCT02754141
Study group	Role	What they receive
Arm A-Monotherapy	Experimental	BMS-986179, dose as specified Receives: Biological: BMS-986179
Arm B- Combination Therapy	Experimental	BMS-986179 + nivolumab, dose as specified Receives: Biological: BMS-986179; Biological: Nivolumab
Arm C-Combination Therapy	Experimental	BMS-986179 + rHuPH20, dose as specified Receives: Biological: BMS-986179; Biological: rHuPH20

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths
Measured: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.

Secondary outcomes (11)

Number of Participants With a Best Overall Response (BOR) at Week 24
Best overall response (BOR) is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
Measured: from initial treatment to week 24
Percentage of Participants With an Objective Response Rate (ORR) at Week 24
ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.
Measured: from initial treatment to week 24
Progression Free Survival Rate (PFSR) at Week 24
PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.
Measured: from initial treatment to week 24
Median Duration of Response (DOR)
DOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.
Measured: from first measure response approximately up to 25 months
Cmax
Cmax is defined as maximum plasma concentration of the drug
Measured: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Tmax
Tmax is defined is the time to maximum plasma concentration
Measured: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
AUC (0-T)
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Measured: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
AUC (Tau)
Area under the plasma concentration time-curve. AUC over the dosing interval.
Measured: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Ctau
Ctau is defined as the concentration of study drug at the end of the dosing interval
Measured: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Mean Change From Baseline in CD73 Assays
Mean change from baseline in CD73 assays at the end of Part 1A treatment period
Assays Measured:
EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score
The H-score is given by the ratio of the weighted sum of the number of positive cells to the total number of detected cells. The H-score captures both the intensity and the proportion of the biomarker of interest from the IHC image and comprises values between 0 and 300. The lower the number equals a better prognosis.
Measured: approximately up to 95 weeks
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
Measured: From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201612 Oct 2021

First posted28 Apr 2016 (estimated)
Study start21 Jun 2016
Primary completion12 Oct 2021
Study completion12 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Malignant Solid TumorStudies 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02754141
Sponsor's protocol ID: CA013-004
Other IDs: 2016-000603-91, 2016
Status last verified: Mar 2023
First submitted: 22 Apr 2016
Last updated: 5 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT02754141
Acronym / sponsor ID: CA013-004
Conditions: Malignant Solid Tumor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 235 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 21 Jun 2016 (actual)
Primary completion: 12 Oct 2021 (actual)
Study completion: 12 Oct 2021 (actual)
First posted: 28 Apr 2016 (estimated)
Results: Posted 5 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm A-Monotherapy	Experimental	Biological: BMS-986179BMS-986179, dose as specified
Arm B- Combination Therapy	Experimental	Biological: BMS-986179, Biological: NivolumabBMS-986179 + nivolumab, dose as specified
Arm C-Combination Therapy	Experimental	Biological: BMS-986179, Biological: rHuPH20BMS-986179 + rHuPH20, dose as specified

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
Eastern Cooperative Oncology Group (ECOG) 0-1
Acceptable lab testing results
Allow biopsies

Key exclusion criteria (5 listed)

Central nervous system (CNS) tumors
Uncontrolled or significant cardiovascular diseases
Active or known autoimmune disease
Organ transplant
Other protocol defined inclusion/exclusion criteria could 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-986179Specified dose on specified days	Biological	Arm A-Monotherapy, Arm B- Combination Therapy, Arm C-Combination Therapy
NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days	Biological	Arm B- Combination Therapy
rHuPH20Specified dose on specified days	Biological	Arm C-Combination Therapy

Primary outcome

Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Time frame: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.
Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths

11 secondary outcomes

Number of Participants With a Best Overall Response (BOR) at Week 24
Time frame: from initial treatment to week 24
Percentage of Participants With an Objective Response Rate (ORR) at Week 24
Time frame: from initial treatment to week 24
Progression Free Survival Rate (PFSR) at Week 24
Time frame: from initial treatment to week 24
Median Duration of Response (DOR)
Time frame: from first measure response approximately up to 25 months
Cmax
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Tmax
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
AUC (0-T)
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
AUC (Tau)
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Ctau
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Mean Change From Baseline in CD73 Assays
Time frame: approximately up to 95 weeks
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
Time frame: From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks

Results and safety

Results posted to the registry on 5 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P1A 150mg	14	1
P1A 300mg	12	2
P1A 600mg	12	4
P1A 1200mg	9	1
P1A 1600mg	12	2
P1B Combo Therapy 150mg	9	0
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg	8	0
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg	7	0
P1B BMS986-179 1600mg	18	6
P2 Combo Pancreatic	19	2
P2 Combo Therapy NSCLC	31	11
P2 Combo Melanoma	15	1
P2 Combo SCCHN	15	1
P2 RCC Monotherapy	19	5
P2 RCC Combo Therapy	18	5
P2 Combo Prostate	14	0
P2 Combo Unassiged	2	2
P2 Monotherapy Unassigned	1	0

Primary outcome: Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.

Time frame: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.. Count of participants. Unit: Participants

Measure	P1A 150mg n = 14	P1A 300mg n = 12	P1A 600mg n = 12	P1A 1200mg n = 9	P1A 1600mg n = 12	P1A Combo Therapy 150mg n = 12	P1A Combo Therapy 300mg n = 11	P1A Combo Therapy 600mg n = 12	P1A Combo Therapy 1200mg n = 7	P1A Combo Therapy 1600mg n = 10	P1B Combo Therapy 150mg n = 9	P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg n = 8	P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg n = 7	P1B BMS986-179 1600mg n = 18	P2 Combo Pancreatic n = 19	P2 Combo Therapy NSCLC n = 31	P2 Combo Melanoma n = 15	P2 Combo SCCHN n = 15	P2 RCC Combo n = 18	P2 RCC Mono n = 19	P2 Combo RCC Crossover n = 3	P2 Combo Prostate n = 14	P2 Combo Unassiged n = 2
Adverse Events	7	4	3	4	5	7	7	6	5	7	5	1	2	4	11	21	7	12	15	8	3	8	1
Serious Adverse Events	0	0	0	0	0	2	0	1	0	1	0	0	0	0	0	1	1	1	1	0	0	0	0
AEs Leading to Discontinuation	0	0	0	0	0	2	0	1	0	0	0	0	0	0	0	2	1	1	0	0	0	0	0
Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All Treated Participants

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P1A 150mg	3 of 14 (21.4%)	11 of 14 (78.6%)	2 of 14
P1A 300mg	4 of 12 (33.3%)	8 of 12 (66.7%)	1 of 12
P1A 600mg	1 of 12 (8.3%)	8 of 12 (66.7%)	0 of 12
P1A 1200mg	2 of 9 (22.2%)	6 of 9 (66.7%)	2 of 9
P1A 1600mg	3 of 12 (25%)	12 of 12 (100%)	2 of 12
P1A All Mono	13 of 59 (22%)	45 of 59 (76.3%)	7 of 59
P1A Combo Therapy 150mg	5 of 12 (41.7%)	11 of 12 (91.7%)	9 of 12
P1A Combo Therapy 300mg	6 of 11 (54.5%)	11 of 11 (100%)	11 of 11
P1A Combo Therapy 600mg	9 of 12 (75%)	12 of 12 (100%)	11 of 12
P1A Combo Therapy 1200mg	3 of 7 (42.9%)	7 of 7 (100%)	6 of 7
P1A Combo Therapy 1600mg	5 of 10 (50%)	9 of 10 (90%)	8 of 10
P1A All Combo	28 of 52 (53.8%)	50 of 52 (96.2%)	45 of 52
P1B Combo Therapy 150mg	7 of 9 (77.8%)	9 of 9 (100%)	9 of 9
P1B Combo Therapy BMS-986179 1200mg + Nivo360mg	7 of 8 (87.5%)	6 of 8 (75%)	8 of 8
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg	4 of 7 (57.1%)	6 of 7 (85.7%)	5 of 7
P1B BMS-986179 1600mg	11 of 18 (61.1%)	17 of 18 (94.4%)	18 of 18
P1B All Combo	18 of 24 (75%)	21 of 24 (87.5%)	22 of 24
P2 Combo Pancreatic

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink 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

24 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986179, Nivolumab and rHuPH20 in people with Malignant Solid Tumor, run by Bristol-Myers Squibb at 24 sites in 7 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada, France, Australia, Germany and 2 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths. (time frame: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.). 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 NCT02754141.

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 5 Apr 2023.