An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer

NCT03351231 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: CA024-0012017-003603-21
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.

Conditions

Cancer

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Adverse Events (AE)

  The primary objective to establish safety to be measured by the primary endpoint of AEs

  From initiation of study treatment until 100 days after discontinuation of study treatment

• Number of Participants With Serious Adverse Events (SAE)

  The primary objective to establish safety to be measured by the primary endpoint of SAEs

  From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study

• Number of Participants With Dose Limiting Toxicities (DLT)

  The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities

  Approximately 2 years

• Number of Participants With AEs Leading to Discontinuation

  The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation

  Approximately 2 years

• Number of Deaths

  The primary objective to establish safety to be measured by the primary endpoint of deaths

  Approximately 2 years

• Number of Participants With Laboratory Abnormalities

  The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities

  Approximately 2 years

Secondary Outcomes (13)

• Maximum Observed Plasma Concentration (Cmax)

  Approximately 2 years

• Time of Maximum Observed Plasma Concentration (Tmax)

  Approximately 2 years

• Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]

  Approximately 2 years

• Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]

  Approximately 2 years

• Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)

  Approximately 2 years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

BMS-986242 administered in combination with Nivolumab

Drug: BMS-986242; Biological: Nivolumab

Dose Expansion

EXPERIMENTAL

BMS-986242 administered in combination with Nivolumab

Drug: BMS-986242; Biological: Nivolumab

Interventions

BMS-986242 DRUG

Specified dose on specified days

Dose Escalation; Dose Expansion

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Anti-PD-1

Dose Escalation; Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Ability to swallow tablets
• Adequate bone marrow and organ function, as defined by the protocol

You may not qualify if:

• Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
• Ocular melanoma
• Any significant acute or chronic medical illness
• Prior malignancy
• Other active malignancy requiring concurrent intervention
• Prior organ allograft or allogeneic bone marrow transplantation
• Participants with active, known, or suspected autoimmune disease
• Requirement for daily supplemental oxygen
• Uncontrolled or significant cardiovascular disease
• Pre-existing liver disease
• Gastrointestinal disease known to interfere with absorption

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

University Of Alabama At Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Hoag Memorial Hospital Presbyterian

Los Angeles, California, 90033, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Local Institution

Baltimore, Maryland, 21287, United States

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; spartalizumab

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: November 27, 2017
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: August 26, 2020
• Results First Posted: October 8, 2019

Record last verified: 2020-08

Locations

US (4)