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

NCT03363776 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: CA034-0012017-002199-24
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (7)

• Number of Participants With an Adverse Event (AE)

  Number of participants who experienced an AE during the course of the study.

  from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

• Number of Participants With a Serious Adverse Event (SAE)

  Number of participants who experienced a SAE during the course of the study.

  from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

• Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria

  Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.

  from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

• Number of Participants With an Adverse Event (AE) Leading to Discontinuation

  Number of participants who experienced an AE leading to discontinuation during the course of the study.

  from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

• Number of Participants With an Adverse Event (AE) Leading to Death

  Number of participants who experienced an AE leading to death during the course of the study.

  from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

• Number of Participants With a Clinical Laboratory Test Abnormality

  Number of participants who experienced a clinical laboratory test abnormality during the course of the study.

  from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

• Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers

  Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.

  from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)

Secondary Outcomes (22)

• Objective Response Rate (ORR)

  at Weeks 8, 16 and 24

• Disease Control Rate (DCR)

  at Weeks 8, 16 and 24

• Median Duration of Response (mDOR)

  at Weeks 8, 16 and 24

• Median Progression-Free Survival (mPFS)

  at Weeks 8, 16 and 24, to progression

• Progression-Free Survival Rate (PFSR)

  at Weeks 8, 16 and 24

Study Arms (3)

Monotherapy

EXPERIMENTAL

BMS-986277 administered alone

Biological: BMS-986277

Combination Dose Escalation Therapy

EXPERIMENTAL

BMS-986277 administered in combination with Nivolumab

Biological: BMS-986277; Biological: Nivolumab

Combination Expansion Therapy

EXPERIMENTAL

BMS-986277 monotherapy with option for subsequent Nivolumab therapy

Biological: BMS-986277; Biological: Nivolumab

Interventions

BMS-986277 BIOLOGICAL

Specified dose on specified days

Combination Dose Escalation Therapy; Combination Expansion Therapy; Monotherapy

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-963558

Combination Dose Escalation Therapy; Combination Expansion Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Sanford Research

Sioux Falls, South Dakota, 57104, United States

Location

Local Institution

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Neoplasms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

please email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 6, 2017
• Study Start: December 6, 2017
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-11

Locations

CA (2); US (1)