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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Cancer

Treatments

Drug: BMS-986242
Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03351231
CA024-001
2017-003603-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

7 participants in 2 patient groups

Dose Escalation
Experimental group
Description:
BMS-986242 administered in combination with Nivolumab
Treatment:
Biological: Nivolumab
Drug: BMS-986242
Dose Expansion
Experimental group
Description:
BMS-986242 administered in combination with Nivolumab
Treatment:
Biological: Nivolumab
Drug: BMS-986242

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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