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

Malignant Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754141
• Other study ID #: CA013-004
• Secondary ID: 2016-000603-91
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 21, 2016
• Est. completion date: October 12, 2021

Study information

• Verified date: March 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Malignant Solid Tumor

Intervention

Biological:
• BMS-986179
Specified dose on specified days
• Nivolumab
Specified dose on specified days
• rHuPH20
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0018	Melbourne	Victoria
Australia	Local Institution - 0019	Randwick	New South Wales
Australia	Local Institution - 0017	Sydney	New South Wales
Canada	Local Institution - 0014	Montreal	Quebec
Canada	Local Institution - 0024	Montreal	Quebec
Canada	Local Institution - 0003	Ottawa	Ontario
Canada	Local Institution - 0002	Toronto	Ontario
France	Local Institution - 0033	Marseille
France	Local Institution - 0021	Marseille Cedex 5
France	Local Institution - 0008	Toulouse Cedex 9
France	Local Institution - 0007	Villejuif Cedex
Germany	Local Institution - 0016	Freiburg
Germany	Local Institution - 0015	Munich
Italy	Local Institution - 0012	Napoli
Italy	Local Institution - 0013	Padova
Netherlands	Local Institution - 0006	Amsterdam
United States	Local Institution - 0001	Baltimore	Maryland
United States	Local Institution - 0022	Boston	Massachusetts
United States	Local Institution - 0023	Buffalo	New York
United States	Local Institution - 0028	Chicago	Illinois
United States	Local Institution - 0009	Dallas	Texas
United States	Local Institution - 0004	Nashville	Tennessee
United States	Local Institution - 0005	New York	New York
United States	Local Institution - 0020	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	from initial treatment to week 24
Secondary	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.	from initial treatment to week 24
Secondary	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.	from initial treatment to week 24
Secondary	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.	from first measure response approximately up to 25 months
Secondary	Cmax	Cmax is defined as maximum plasma concentration of the drug	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
Secondary	Tmax	Tmax is defined is the time to maximum plasma concentration	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
Secondary	AUC (0-T)	Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration	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
Secondary	AUC (Tau)	Area under the plasma concentration time-curve. AUC over the dosing interval.	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
Secondary	Ctau	Ctau is defined as the concentration of study drug at the end of the dosing interval	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
Secondary	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.	approximately up to 95 weeks
Secondary	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.	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls