All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

BMS-986179 + nivolumab, dose as specified

BMS-986179

rHuPH20

Bristol-Myers Squibb

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.

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

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

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

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.

ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.

PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.

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.

Cmax is defined as maximum plasma concentration of the drug

Tmax is defined is the time to maximum plasma concentration

Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration

Area under the plasma concentration time-curve. AUC over the dosing interval.

Ctau is defined as the concentration of study drug at the end of the dosing interval

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.

A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.

P1A 150mg

P1A 300mg

P1A 600mg

P1A 1200mg

P1A 1600mg

P1A all treated participants in monotherapy

P1A All Mono

P1A Combo Therapy 150mg

P1A Combo Therapy 300mg

P1A Combo Therapy 600mg

P1A Combo Therapy 1200mg

P1A Combo Therapy 1600mg

P1A all treated participants in combo therapy

P1A All Combo

P1B Combo Therapy 150mg

P1B Combo Therapy BMS-986179 1200mg + Nivo360mg

P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg

P1B BMS-986179 1600mg

All treated participants in P1B combo therapy period

P1B All Combo

P2 Combo Pancreatic

P2 Combo NSCLC

P2 Combo Melanoma

P2 Combo SCCHN

P2 RCC Combo

P2 RCC Mono

P2 RCC Crossover

P2 Combo Prostate

P2 Monotherapy Unassigned

P2 Combo Unassigned

All Treated participants in the P2 treatment period

P2 All Combo Therapy

All treated participants in P1A, P1B and P2 combo therapy periods

ALL Combo (P1A+P1B+P2)

BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy

BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy

BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy

BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy

BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy

P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg

P1B BMS986-179 1600mg

P2 Combo Therapy NSCLC

BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

P2 Combo Unassiged

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

Adverse Events

Serious Adverse Events

AEs Leading to Discontinuation

Deaths

P2 Combo RCC Crossover

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

Complete Response

Partial Response

Number of Participants With a Best Overall Response (BOR) at Week 24

Percentage of Participants With an Objective Response Rate (ORR) at Week 24

Progression Free Survival Rate (PFSR) at Week 24

Median Duration of Response (DOR)

Cycle 0 Day 1

Cycle 1 Day 1

Cycle 1 Day 22

Cycle 2 Day 1

Cycle 4 Day 15

All Treated Participants with evaluable cmax measurements at specified time points

Cmax

All Treated Participants with evaluable tmax measurements at specified time points

Tmax

All Treated Participants with evaluable AUC (0-T) measurements at specified time points

AUC (0-T)

All Treated Participants with evaluable AUC (Tau) measurements at specified time points

AUC (Tau)

All Treated Participants with evaluable Ctau measurements at specified time points

Ctau

EHC CD73 H-Score

IHC CD73 Cytoplasm H-Score

IHC CD73 Membrane H-Score

All Treated Participants with evaluable CD73 assay measurements for each assay

Mean Change From Baseline in CD73 Assays

BMS-986179 ADA+

Nivolumab ADA+

BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240mg Combo Therapy

BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg Combo Therapy

BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg Combo Therapy

BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg Combo Therapy

BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg Combo Therapy

Spots Global Cancer Trial Database for An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial