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

Phase 1

Completed

• Conditions: Malignant Solid Tumor
• Interventions: Biological: BMS-986179; Biological: Nivolumab; Biological: rHuPH20

• Registration Number: NCT02754141
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Study Start: 2016-06-21
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Results First Submitted: 2022-10-12
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-10
• Last Update Submitted: 2023-03-10
• Results First Posted: 2023-04-05
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A-Monotherapy	BMS-986179	BMS-986179, dose as specified
Arm B- Combination Therapy	Nivolumab	BMS-986179 + nivolumab, dose as specified
Arm B- Combination Therapy	BMS-986179	BMS-986179 + nivolumab, dose as specified
Arm C-Combination Therapy	rHuPH20	BMS-986179 + rHuPH20, dose as specified
Arm C-Combination Therapy	BMS-986179	BMS-986179 + rHuPH20, dose as specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and 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.	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

Secondary Outcome Measures

Name	Time	Method
Cmax	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	Cmax is defined as maximum plasma concentration of the drug
Tmax	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 is defined is the time to maximum plasma concentration
Median Duration of Response (DOR)	from first measure response approximately up to 25 months	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.
Progression Free Survival Rate (PFSR) at Week 24	from initial treatment to week 24	PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.
Number of Participants With a Best Overall Response (BOR) at Week 24	from initial treatment to 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.
AUC (0-T)	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	Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Percentage of Participants With an Objective Response Rate (ORR) at Week 24	from initial treatment to week 24	ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.
AUC (Tau)	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	Area under the plasma concentration time-curve. AUC over the dosing interval.
Mean Change From Baseline in CD73 Assays	approximately up to 95 weeks	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.
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.	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	A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
Ctau	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 is defined as the concentration of study drug at the end of the dosing interval

Trial Locations

Locations (24)

Local Institution - 0017; 🇦🇺 Sydney, New South Wales, Australia

Local Institution - 0006; 🇳🇱 Amsterdam, Netherlands

Local Institution - 0022; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0028; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0001; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0023; 🇺🇸 Buffalo, New York, United States

Local Institution - 0005; 🇺🇸 New York, New York, United States

Local Institution - 0020; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0004; 🇺🇸 Nashville, Tennessee, United States

Local Institution - 0009; 🇺🇸 Dallas, Texas, United States

Local Institution - 0019; 🇦🇺 Randwick, New South Wales, Australia

Local Institution - 0018; 🇦🇺 Melbourne, Victoria, Australia

Local Institution - 0002; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0024; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0003; 🇨🇦 Ottawa, Ontario, Canada

Local Institution - 0021; 🇫🇷 Marseille Cedex 5, France

Local Institution - 0033; 🇫🇷 Marseille, France

Local Institution - 0008; 🇫🇷 Toulouse Cedex 9, France

Local Institution - 0016; 🇩🇪 Freiburg, Germany

Local Institution - 0015; 🇩🇪 Munich, Germany

Local Institution - 0007; 🇫🇷 Villejuif Cedex, France

Local Institution - 0012; 🇮🇹 Napoli, Italy

Local Institution - 0013; 🇮🇹 Padova, Italy

Local Institution - 0014; 🇨🇦 Montreal, Quebec, Canada