Advanced CancerPhase 1/2NCT02737475

An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread

A Phase 1/2 study testing BMS-986178, Nivolumab and Ipilimumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 22 sites in 6 countries.

Completed

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

Official record

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Trial summary

The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in participants 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: Advanced Cancer
What is being tested?: BMS-986178, Nivolumab and Ipilimumab
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: 22 sitesin 6 countries
Study dates: 17 Jun 2016to 2 Nov 2020
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

For Part 9 (only arm open for enrollment):
Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapies in the advanced metastatic setting
Participants with < 12 months from receipt of last curative-intent chemotherapy are allowed; curative chemotherapy will be considered first-line therapy
Prior receipt of chemotherapy in the (neo)adjuvant setting is acceptable, as long as completed greater than 6 months from start of treatment
Tumor biopsy samples (mandatory pre- and on-treatment biopsies) are required for all participants enrolled
Must have histologic or cytologic confirmation of a malignancy that is advanced (metastatic, recurrent, refractory, and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Men and women must agree to follow specific methods of contraception, if applicable

Who cannot join

Must be immunotherapy treatment naïve, including no prior therapy with T cell immune checkpoint blocker (anti-PDL1, anti-PD1). Prior receipt of intralymphatic cytokine therapy (IRX-2) is acceptable (Part 9 only)
Other active malignancy requiring concurrent intervention
Prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-OX40 antibody, anti-CD137, anti- glucocorticoid-induced TNFR-related gene (anti-GITR) antibody, and anti-CD27
Known or underlying medical or psychiatric condition and/or social reason that, in the opinion of the investigator or Sponsor, could make the administration of study drug hazardous to the participant or could adversely affect the ability of the participant to comply with or tolerate the study
Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

22 sites in 6 countries.

Country

City, postcode or hospital

22 sites in 6 countries

United States8 sites

University Of Colorado
Aurora, Colorado, 80045
Roswell Park Cancer Institute
Buffalo, New York, 14263
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Columbia University Medical Center (Cumc)
New York, New York, 10032
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Providence Portland Medical Center
Portland, Oregon, 97213
Oregon Health & Science University
Portland, Oregon, 97239
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007

Other trials in United States

Spain5 sites

H. Univ. Vall dHebron
Barcelona, 08035
Fundacion Jimenez Diaz
Madrid, 28049
Hosp. Univ. Puerta De Hierro
Majadahonda - Madrid, 28222
Hospital Universitario Virgen De La Victoria
Málaga, 29010
Clinica Universidad de Navarra
Pamplona, 31008

Other trials in Spain

Canada3 sites

Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Local Institution
Ottawa, Ontario, K1H 8L6
Local Institution
Toronto, Ontario, M5G 1Z5

Other trials in Canada

Israel2 sites

Local Institution
Ramat Gan, 52621
Local Institution
Tel Aviv, 64239

Other trials in Israel

Italy2 sites

IRCCS Istituto Nazionale Tumori Milano
Milan, 20133
Istituto Clinico Humanitas
Rozzano, 20089

Other trials in Italy

Netherlands2 sites

Local Institution
Amsterdam, 1066 CX
Local Institution
Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors

Conditions: Advanced Cancer
Being tested: BMS-986178, Nivolumab, Ipilimumab, Tetanus vaccine, DPV-001 vaccine

What participants receive

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

BMS-986178Drug
Specified dose on specified days
NivolumabDrug
Also called BMS-936558, Opdivo
Specified dose on specified days
IpilimumabDrug
Also called BMS-734016, Yervoy
Specified dose on specified days
Tetanus vaccineBiological
Specified dose on specified days
DPV-001 vaccineBiological
DPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days
CyclophosphamideDrug
Specified dose on specified days

Study groups in NCT02737475
Study group	Role	What they receive
Part 1: Dose Escalation	Experimental	* BMS-986178 at specified doses at specified intervals * Enrollment is closed for this arm Receives: Drug: BMS-986178
Part 2: Dose Escalation and Expansion	Experimental	* BMS-986178 in combination with Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm Receives: Drug: BMS-986178; Drug: Nivolumab
Part 3: Dose Escalation and Expansion	Experimental	* BMS-986178 in combination with Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm Receives: Drug: BMS-986178; Drug: Ipilimumab
Part 4: Dose Schedule and Exploration	Experimental	* BMS-986178/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm Receives: Drug: BMS-986178; Drug: Nivolumab
Part 5: Dose Schedule and Exploration	Experimental	* BMS-986178/Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm Receives: Drug: BMS-986178; Drug: Ipilimumab
Part 6: Dose Safety and Expansion	Experimental	* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm Receives: Drug: BMS-986178; Drug: Nivolumab; Drug: Ipilimumab
Part 7: Dose Safety and Expansion	Experimental	* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm Receives: Drug: BMS-986178; Drug: Nivolumab; Drug: Ipilimumab
Part 8: Dose Exploration	Experimental	* BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval * Enrollment is closed for this arm Receives: Drug: BMS-986178; Drug: Nivolumab; Biological: Tetanus vaccine
Part 9: Dose Exploration	Experimental	* BMS-986178/Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 1) at specified doses at specified intervals OR Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 2) at specified doses at specified intervals * Enrollment is open for this arm [Tumor type triple negative breast cancer (TNBC)] Receives: Drug: BMS-986178; Drug: Nivolumab; Biological: DPV-001 vaccine; Drug: Cyclophosphamide

What is being measured

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

The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Measured: From first dose to 28 days after first dose
The Number of Participants Experiencing Adverse Events (AEs)
The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Measured: From first dose to 100 days after last dose (up to approximately 2.5 years)
The Number of Participants Experiencing Serious Adverse Events (SAEs)
The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.
Measured: From first dose to 100 days after last dose (up to approximately 2.5 years)
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Measured: From first dose to 100 days after last dose (up to approximately 2.5 years)
The Number of Participant Deaths
The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
Measured: From first dose to study completion (up to approximately 4 years 5 months)
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
Measured: From baseline to 100 days after last dose (up to approximately 2.5 years)
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
Measured: From baseline to 100 days after last dose (up to approximately 2.5 years)
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
Measured: From baseline to 100 days after last dose (up to approximately 2.5 years)

Secondary outcomes (21)

Objective Response Rate (ORR)
The total number of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) based on assessment of tumor response using RECIST v1.1.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Overall Response (OR) = CR + PR Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
Measured: From baseline up to approximately 2.5 years
Duration of Response (DOR)
The time between the date of first response and the subsequent date of disease progression or death (death after re-treatment will not be considered), whichever occurs first in participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Best overall response (BOR) is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
Due to high percentage of censored response, median estimate may be misleading
Measured: From baseline up to approximately 2.5 years
Progression Free Survival (PFS) Rate at 24 Weeks
The percentage of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Measured: 24 weeks after first dose
Cmax: Maximum Observed Serum Concentration
The maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Tmax: Time of Maximum Observed Serum Concentration
The time of maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
The area under the serum concentration-time curve from time 0 to time t was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
The area under the serum concentration-time curve in 1 dosing interval was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
The observed serum concentration at the end of a dosing interval when intensive samples are collected was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
CLT: Total Body Clearance
The total body clearance was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
The average concentration over a dosing interval (AUC(TAU)/tau) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
The effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab
Measured: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Ctrough: Trough Observed Plasma Concentration
Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Measured: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
Frequency of Positive Anti-Drug Antibodies (ADA) to BMS-986178
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab. ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment.
Measured: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)
Frequency of Positive Anti-Drug Antibodies (ADA) to Nivolumab
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of Nivolumab administered with BMS-986178 ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment.
Measured: Cycle 1-6 timepoints can include (Pre-dose, 336, 696 hours post dose)
Frequency of Positive Anti-Drug Antibodies (ADA) to Ipilimumab.
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of Ipilimumab administered with BMS-986178 ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment.
Measured: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8. A threshold of 80% receptor occupancy following treatment was applied.
Measured: Cycle 1-6 timepoints can include (Pre-dose, 24, 168, 336, 672, 1848 hours post dose)
Tumor Pharmacodynamics of BMS-986178 in Combination With Nivolumab or Nivolumab Monotherapy in Part 8
Tumor pharmacodynamics of BMS-986178 in combination with nivolumab or nivolumab monotherapy
Measured: Screening, cycle 1-2 timepoints can include (Pre-dose, 336, 1848 hours post dose)
The Number of Participants With Sustained T Cell Expansion With DPV-001 in Combination With Nivolumab or Nivolumab Monotherapy in Part 9
The number of participants with Sustained T Cell Expansion with DPV-001 in Combination with Nivolumab or Nivolumab Monotherapy was assessed to show a change in pharmacodynamics biomarkers
Measured: Cycle 1-6 timepoints can include (Pre-dose, 24, 168, 336, 672, 1848 hours post dose)

Timeline

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

17 Jun 20162 Nov 2020

First posted14 Apr 2016 (estimated)
Study start17 Jun 2016
Primary completion2 Nov 2020
Study completion2 Nov 2020

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.
Publications (1)Papers the sponsor has linked to this study.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02737475
Sponsor's protocol ID: CA012-004
Other IDs: 2015-004816-39, 2015
Status last verified: Dec 2021
First submitted: 8 Apr 2016
Last updated: 25 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Gutierrez M, Moreno V, Heinhuis KM, Olszanski AJ, Spreafico A, Ong M, Chu Q, Carvajal RD, Trigo J, Ochoa de Olza M, Provencio M, De Vos FY, De Braud F, Leong S, Lathers D, Wang R, Ravindran P, Feng Y, Aanur P, Melero I. OX40 Agonist BMS-986178 Alone or in Combination With Nivolumab and/or Ipilimumab in Patients With Advanced Solid Tumors. Clin Cancer Res. 2021 Jan 15;27(2):460-472. doi: 10.1158/1078-0432.CCR-20-1830. Epub 2020 Nov 4.
PubMed 33148673

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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT02737475
Acronym / sponsor ID: CA012-004
Conditions: Advanced Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 17 Jun 2016 (actual)
Primary completion: 2 Nov 2020 (actual)
Study completion: 2 Nov 2020 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Posted 25 Jan 2022

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Part 1: Dose Escalation	Experimental	Drug: BMS-986178* BMS-986178 at specified doses at specified intervals * Enrollment is closed for this arm
Part 2: Dose Escalation and Expansion	Experimental	Drug: BMS-986178, Drug: Nivolumab* BMS-986178 in combination with Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 3: Dose Escalation and Expansion	Experimental	Drug: BMS-986178, Drug: Ipilimumab* BMS-986178 in combination with Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 4: Dose Schedule and Exploration	Experimental	Drug: BMS-986178, Drug: Nivolumab* BMS-986178/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 5: Dose Schedule and Exploration	Experimental	Drug: BMS-986178, Drug: Ipilimumab* BMS-986178/Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 6: Dose Safety and Expansion	Experimental	Drug: BMS-986178, Drug: Nivolumab, Drug: Ipilimumab* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 7: Dose Safety and Expansion	Experimental	Drug: BMS-986178, Drug: Nivolumab, Drug: Ipilimumab* BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm
Part 8: Dose Exploration	Experimental	Drug: BMS-986178, Drug: Nivolumab, Biological: Tetanus vaccine* BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval * Enrollment is closed for this arm
Part 9: Dose Exploration	Experimental	Drug: BMS-986178, Drug: Nivolumab, Biological: DPV-001 vaccine, Drug: Cyclophosphamide* BMS-986178/Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 1) at specified doses at specified intervals OR Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 2) at specified doses at specified intervals * Enrollment is open for this arm [Tumor type triple negative breast cancer (TNBC)]

Who may qualify

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

Key inclusion criteria (8 listed)

Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapies in the advanced metastatic setting
Participants with < 12 months from receipt of last curative-intent chemotherapy are allowed; curative chemotherapy will be considered first-line therapy
Prior receipt of chemotherapy in the (neo)adjuvant setting is acceptable, as long as completed greater than 6 months from start of treatment
Tumor biopsy samples (mandatory pre- and on-treatment biopsies) are required for all participants enrolled
Must have histologic or cytologic confirmation of a malignancy that is advanced (metastatic, recurrent, refractory, and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Key exclusion criteria (5 listed)

Must be immunotherapy treatment naïve, including no prior therapy with T cell immune checkpoint blocker (anti-PDL1, anti-PD1). Prior receipt of intralymphatic cytokine therapy (IRX-2) is acceptable (Part 9 only)
Other active malignancy requiring concurrent intervention
Prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-OX40 antibody, anti-CD137, anti- glucocorticoid-induced TNFR-related gene (anti-GITR) antibody, and anti-CD27
Known or underlying medical or psychiatric condition and/or social reason that, in the opinion of the investigator or Sponsor, could make the administration of study drug hazardous to the participant or could adversely affect the ability of the participant to comply with or tolerate the study
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-986178Specified dose on specified days	Drug	Part 1: Dose Escalation, Part 2: Dose Escalation and Expansion, Part 3: Dose Escalation and Expansion, Part 4: Dose Schedule and Exploration, Part 5: Dose Schedule and Exploration, Part 6: Dose Safety and Expansion, Part 7: Dose Safety and Expansion, Part 8: Dose Exploration, Part 9: Dose Exploration
NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days	Drug	Part 2: Dose Escalation and Expansion, Part 4: Dose Schedule and Exploration, Part 6: Dose Safety and Expansion, Part 7: Dose Safety and Expansion, Part 8: Dose Exploration, Part 9: Dose Exploration
IpilimumabAlso: BMS-734016, YervoySpecified dose on specified days	Drug	Part 3: Dose Escalation and Expansion, Part 5: Dose Schedule and Exploration, Part 6: Dose Safety and Expansion, Part 7: Dose Safety and Expansion
Tetanus vaccineSpecified dose on specified days	Biological	Part 8: Dose Exploration
DPV-001 vaccineDPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days	Biological	Part 9: Dose Exploration
CyclophosphamideSpecified dose on specified days	Drug	Part 9: Dose Exploration

Primary outcome

The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: From first dose to 28 days after first dose
The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
The Number of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose to 100 days after last dose (up to approximately 2.5 years)
The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
The Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: From first dose to 100 days after last dose (up to approximately 2.5 years)
The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Time frame: From first dose to 100 days after last dose (up to approximately 2.5 years)
The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
The Number of Participant Deaths
Time frame: From first dose to study completion (up to approximately 4 years 5 months)
The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
Time frame: From baseline to 100 days after last dose (up to approximately 2.5 years)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
Time frame: From baseline to 100 days after last dose (up to approximately 2.5 years)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
Time frame: From baseline to 100 days after last dose (up to approximately 2.5 years)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time

21 secondary outcomes

Objective Response Rate (ORR)
Time frame: From baseline up to approximately 2.5 years
Duration of Response (DOR)
Time frame: From baseline up to approximately 2.5 years
Progression Free Survival (PFS) Rate at 24 Weeks
Time frame: 24 weeks after first dose
Cmax: Maximum Observed Serum Concentration
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Tmax: Time of Maximum Observed Serum Concentration
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
CLT: Total Body Clearance
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
Time frame: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
Ctrough: Trough Observed Plasma Concentration
Time frame: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
Frequency of Positive Anti-Drug Antibodies (ADA) to BMS-986178
Time frame: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)
Frequency of Positive Anti-Drug Antibodies (ADA) to Nivolumab
Time frame: Cycle 1-6 timepoints can include (Pre-dose, 336, 696 hours post dose)
Frequency of Positive Anti-Drug Antibodies (ADA) to Ipilimumab.
Time frame: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8
Time frame: Cycle 1-6 timepoints can include (Pre-dose, 24, 168, 336, 672, 1848 hours post dose)
Tumor Pharmacodynamics of BMS-986178 in Combination With Nivolumab or Nivolumab Monotherapy in Part 8
Time frame: Screening, cycle 1-2 timepoints can include (Pre-dose, 336, 1848 hours post dose)
The Number of Participants With Sustained T Cell Expansion With DPV-001 in Combination With Nivolumab or Nivolumab Monotherapy in Part 9
Time frame: Cycle 1-6 timepoints can include (Pre-dose, 24, 168, 336, 672, 1848 hours post dose)

Results and safety

Results posted to the registry on 25 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Escalation Part 1: BMS 20 mg Q2W	4	3
Escalation Part 1: BMS 40 mg Q2W	4	4
Escalation Part 1: BMS 80 mg Q2W	4	4
Escalation Part 1: BMS 160 mg Q2W	4	3
Escalation Part 1: BMS 320 mg Q2W	4	3
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W	7	4
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W	8	8
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W	12	10
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W	8	7
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W	8	8
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W	4	3
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W	10	6
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W	7	5
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W	8	6
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W	6	5
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)	18	15
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W	12	10
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W	6	2
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)	7	5
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)	1	1
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)	6	4
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)	9	8
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W	2	2
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W	2	1
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W	2	1
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W	2	1
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine	1	0

Primary outcome: The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

Time frame: From first dose to 28 days after first dose. Count of participants. Unit: Participants

Measure	Escalation Part 1: BMS 20 mg Q2W n = 4	Escalation Part 1: BMS 40 mg Q2W n = 4	Escalation Part 1: BMS 80 mg Q2W n = 4	Escalation Part 1: BMS 160 mg Q2W n = 4	Escalation Part 1: BMS 320 mg Q2W n = 4	Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W n = 7	Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W n = 12	Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W n = 8	Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W n = 4	Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W n = 10	Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W n = 7	Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W n = 8	Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W n = 6	Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) n = 18	Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W n = 12	Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W n = 6	Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 7	Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 1	Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 6	Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 9	Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W

Primary outcome: The Number of Participants Experiencing Adverse Events (AEs)

Time frame: From first dose to 100 days after last dose (up to approximately 2.5 years). Count of participants. Unit: Participants

Measure	Escalation Part 1: BMS 20 mg Q2W n = 4	Escalation Part 1: BMS 40 mg Q2W n = 4	Escalation Part 1: BMS 80 mg Q2W n = 4	Escalation Part 1: BMS 160 mg Q2W n = 4	Escalation Part 1: BMS 320 mg Q2W n = 4	Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W n = 7	Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W n = 12	Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W n = 8	Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W n = 4	Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W n = 10	Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W n = 7	Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W n = 8	Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W n = 6	Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) n = 18	Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W n = 12	Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W n = 6	Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 7	Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 1	Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 6	Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 9

Primary outcome: The Number of Participants Experiencing Serious Adverse Events (SAEs)

Time frame: From first dose to 100 days after last dose (up to approximately 2.5 years). Count of participants. Unit: Participants

Measure	Escalation Part 1: BMS 20 mg Q2W n = 4	Escalation Part 1: BMS 40 mg Q2W n = 4	Escalation Part 1: BMS 80 mg Q2W n = 4	Escalation Part 1: BMS 160 mg Q2W n = 4	Escalation Part 1: BMS 320 mg Q2W n = 4	Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W n = 7	Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W n = 12	Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W n = 8	Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W n = 4	Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W n = 10	Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W n = 7	Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W n = 8	Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W n = 6	Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) n = 18	Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W n = 12	Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W n = 6	Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 7	Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 1	Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 6	Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 9

Primary outcome: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

Time frame: From first dose to 100 days after last dose (up to approximately 2.5 years). Count of participants. Unit: Participants

Measure	Escalation Part 1: BMS 20 mg Q2W n = 4	Escalation Part 1: BMS 40 mg Q2W n = 4	Escalation Part 1: BMS 80 mg Q2W n = 4	Escalation Part 1: BMS 160 mg Q2W n = 4	Escalation Part 1: BMS 320 mg Q2W n = 4	Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W n = 7	Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W n = 12	Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W n = 8	Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W n = 8	Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W n = 4	Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W n = 10	Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W n = 7	Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W n = 8	Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W n = 6	Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) n = 18	Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W n = 12	Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W n = 6	Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 7	Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC) n = 1	Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 6	Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC) n = 9

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Escalation Part 1: BMS 20 mg Q2W	3 of 4 (75%)	4 of 4 (100%)	4 of 4
Escalation Part 1: BMS 40 mg Q2W	4 of 4 (100%)	4 of 4 (100%)	4 of 4
Escalation Part 1: BMS 80 mg Q2W	2 of 4 (50%)	4 of 4 (100%)	3 of 4
Escalation Part 1: BMS 160 mg Q2W	3 of 4 (75%)	3 of 4 (75%)	4 of 4
Escalation Part 1: BMS 320 mg Q2W	3 of 4 (75%)	4 of 4 (100%)	4 of 4
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W	3 of 7 (42.9%)	7 of 7 (100%)	3 of 7
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W	6 of 8 (75%)	8 of 8 (100%)	7 of 8
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W	7 of 12 (58.3%)	12 of 12 (100%)	11 of 12
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W	4 of 8 (50%)	6 of 8 (75%)	6 of 8
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W	5 of 8 (62.5%)	8 of 8 (100%)	6 of 8
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W	2 of 4 (50%)	4 of 4 (100%)	4 of 4
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W	6 of 10 (60%)	10 of 10 (100%)	9 of 10
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W	6 of 7 (85.7%)	7 of 7 (100%)	7 of 7
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W	5 of 8 (62.5%)	8 of 8 (100%)	8 of 8
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W	2 of 6 (33.3%)	6 of 6 (100%)	2 of 6
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)	11 of 18 (61.1%)	18 of 18 (100%)	16 of 18
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33148673Gutierrez M, Moreno V, Heinhuis KM, Olszanski AJ, Spreafico A, Ong M, Chu Q, Carvajal RD, Trigo J, Ochoa de Olza M, Provencio M, De Vos FY, De Braud F, Leong S, Lathers D, Wang R, Ravindran P, Feng Y, Aanur P, Melero I. OX40 Agonist BMS-986178 Alone or in Combination With Nivolumab and/or Ipilimumab in Patients With Advanced Solid Tumors. Clin Cancer Res. 2021 Jan 15;27(2):460-472. doi: 10.1158/1078-0432.CCR-20-1830. Epub 2020 Nov 4.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink 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

22 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986178, Nivolumab and Ipilimumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 22 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Spain, Canada, Israel, Italy 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 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 25 Jan 2022). 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?

The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: From first dose to 28 days after first dose). 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?

On the ClinicalTrials.gov record for NCT02737475, which also lists 1 linked publication.

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 25 Jan 2022.