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Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 1

Conditions

Cancer

Treatments

Drug: Nivolumab
Drug: Relatlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02966548
CA224-034

Details and patient eligibility

About

This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.

Enrollment

35 patients

Sex

All

Ages

20+ 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:

  • Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
  • Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
  • Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
  • Males and Females, ages 20 years or older, inclusive

Exclusion Criteria:

  • Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
  • Other concomitant malignancies (with some exceptions per protocol)
  • Any active autoimmune disease or history of known or suspected autoimmune disease
  • History of uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Monotherapy
Experimental group
Description:
Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation
Treatment:
Drug: Relatlimab
Combination Therapy
Experimental group
Description:
Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
Treatment:
Drug: Nivolumab
Drug: Relatlimab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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