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An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

NCT ID: NCT03363776

Last Updated: 2020-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2019-11-22

Brief Summary

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The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

BMS-986277 administered alone

Group Type EXPERIMENTAL

BMS-986277

Intervention Type BIOLOGICAL

Specified dose on specified days

Combination Dose Escalation Therapy

BMS-986277 administered in combination with Nivolumab

Group Type EXPERIMENTAL

BMS-986277

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Combination Expansion Therapy

BMS-986277 monotherapy with option for subsequent Nivolumab therapy

Group Type EXPERIMENTAL

BMS-986277

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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BMS-986277

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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Opdivo BMS-963558

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
* Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
* Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
* ECOG performance status less than or equal to 2

Exclusion Criteria

* Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
* Participants with carcinomatous meningitis
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
* Participants with active, known, or suspected autoimmune disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Sanford Research

Sioux Falls, South Dakota, United States

Site Status

Local Institution

Ottawa, Ontario, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Australia Spain United States Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2017-002199-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA034-001

Identifier Type: -

Identifier Source: org_study_id