Clinical Trial: NCT03994601 - My Cancer Genome

NCT03994601

Description:

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors

Related Conditions:

Malignant Solid Tumor

Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03994601

Trial Eligibility

Document

Title

Brief Title: An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Official Title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Clinical Trial IDs

ORG STUDY ID: CA043-001
NCT ID: NCT03994601

Conditions

Advanced Cancer

Interventions

Drug	Synonyms	Arms
BMS-986288		Arm A BMS-986288
Nivolumab	Opdivo/BMS 936558	Arm B BMS-986288 in combination with Nivolumab

Purpose

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors

Trial Arms

Name	Type	Description	Interventions
Arm A BMS-986288	Experimental	Specified dose on specified days	BMS-986288
Arm B BMS-986288 in combination with Nivolumab	Experimental	Specified dose on specified days	BMS-986288 Nivolumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologic or cytologic confirmation of select solid tumor that is advanced
             (metastatic, recurrent, and/or unresectable) with measurable disease and have at least
             1 lesion accessible for biopsy

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Participants must have received, and then progressed, relapsed, or been intolerant to,
             at least 1 standard treatment regimen in the advanced or metastatic setting according
             to select solid tumor histologies

        Exclusion Criteria:

          -  Participants with active, known or suspected autoimmune disease

          -  Participants with other active malignancy requiring concurrent intervention

          -  Participants with primary CNS malignancies or tumors with CNS metastasis as the only
             site of disease, will be excluded

        Other protocol defined inclusion/exclusion criteria could apply

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities
Time Frame:	Up to 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Maximum Observed Concentration (Cmax) of BMS-986288
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Time of Maximum Observed Concentration (Tmax) of BMS-986288
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Trough Observed Concentrations (Ctrough) of BMS-986288
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Total Body Clearance (CLT) of BMS-986288
Time Frame:	Up to 4 months
Safety Issue:
Description:

Measure:	Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288
Time Frame:	Up to 4 months
Safety Issue:
Description:

Measure:	Accumulation Index (AI) of BMS-986288
Time Frame:	Up to 4 months
Safety Issue:
Description:

Measure:	Terminal Half-Life (T-HALF) of BMS-986288
Time Frame:	Up to 4 months
Safety Issue:
Description:

Measure:	Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288
Time Frame:	Up to 2 years
Safety Issue:
Description:

Measure:	Objective Response Rate (ORR) of Participants
Time Frame:	Up to 4 years
Safety Issue:
Description:

Measure:	Duration of Response (DOR) of Participants
Time Frame:	Up to 4 years
Safety Issue:
Description:

Measure:	Progression-Free Survival (PFS) of Participants
Time Frame:	Up to 4 years
Safety Issue:
Description:

Measure:	Time to Response (TTR) of Participants
Time Frame:	Up to 4 years
Safety Issue:
Description:

Measure:	Percentage of change from baseline in T-regulatory cells (Tregs)
Time Frame:	Up to 2 years
Safety Issue:
Description:

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

February 17, 2020

Clinical Trials /

An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers