Clinical Trial: NCT02913313 - My Cancer Genome

NCT02913313

Description:

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

Related Conditions:

Malignant Solid Tumor

Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02913313

Trial Eligibility

Document

Title

Brief Title: An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread
Official Title: Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

Clinical Trial IDs

ORG STUDY ID: CA020-002
SECONDARY ID: 2016-002263-34
NCT ID: NCT02913313

Conditions

Broad Solid Tumor

Interventions

Drug	Synonyms	Arms
BMS-986207		Part 1A: Dose Escalation Monotherapy (BMS-986207)
Nivolumab	BMS-936558, Opdivo	Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab)
Ipilimumab	BMS-734016, Yervoy	Part 1C: Triplet Cohort (BMS-986207 + nivolumab + ipilimumab)

Purpose

Trial Arms

Name	Type	Interventions
Part 1A: Dose Escalation Monotherapy (BMS-986207)	Experimental	BMS-986207
Part 1B: Dose Escalation Combination Therapy (BMS-986207 + nivolumab)	Experimental	BMS-986207 Nivolumab
Part 2A: Expansion Monotherapy (BMS-986207)	Experimental	BMS-986207
Part 2B: Expansion Combination Therapy (BMS-986207 + nivolumab)	Experimental	BMS-986207 Nivolumab
Part 1C: Triplet Cohort (BMS-986207 + nivolumab + ipilimumab)	Experimental	BMS-986207 Nivolumab Ipilimumab
Part 2C: Triplet Expansion (BMS-986207 + nivolumab + ipilimumab)	Experimental	BMS-986207 Nivolumab Ipilimumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participant must consent for pretreatment and on treatment tumor biopsy samples

          -  For Part 1C tumor biopsies are optional

          -  Nonsmall cell lung cancer (NSCLC) without prior treatment in the advanced or
             metastatic setting (Part 2C)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Must have received, and progressed or been intolerant to, at least 1 standard
             treatment regimen in the advanced or metastatic setting (Part 1A, 1B and 1C)

          -  Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per
             Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic
             tumor assessment performed within 28 days before randomization

        Exclusion Criteria:

          -  Primary central nervous system (CNS) disease, or tumors with CNS metastases as the
             only site of disease. Controlled brain metastases will be allowed to enroll

          -  Other active malignancy requiring concurrent intervention

          -  Uncontrolled/significant heart disease

          -  History of chronic hepatitis [except for hepatocellular carcinoma (HCC)]

          -  Active, known, or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria 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)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Objective response rate (ORR)
Time Frame:	Up to 36 months
Safety Issue:
Description:

Measure:	Median duration of response (mDOR)
Time Frame:	Up to 36 months
Safety Issue:
Description:

Measure:	Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame:	At 24 Weeks
Safety Issue:
Description:

Measure:	Maximum observed serum concentration (Cmax)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Time of maximum observed serum concentration (Tmax)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Area under the concentration-time curve in one dosing interval AUC(TAU)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Observed concentration at the end of a dosing interval (Ctau)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Total body clearance (CLT)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Average concentration over a dosing interval (Css-avg)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Accumulation Index (AI)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Trough observed serum concentrations (Ctrough)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Measure:	Incidence of anti-drug antibody (ADA)
Time Frame:	Up to 15 months
Safety Issue:
Description:

Details

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

Last Updated

July 26, 2021

Clinical Trials /

An Investigational Immuno-therapy Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Solid Cancers That Are Advanced or Have Spread