NCT02966548

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2024

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

7.5 years

First QC Date

November 1, 2016

Last Update Submit

February 14, 2025

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

  • Number of adverse events (AE)

    Approximately 2.2 years

  • Number of serious adverse events (SAE)

    Approximately 2.2 years

  • Number of deaths

    Approximately 2.2 years

  • Number of laboratory abnormalities

    Approximately 2.2 years

Secondary Outcomes (18)

  • Maximum observed serum concentration (Cmax) of BMS-986016

    Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

  • Time of maximum observed serum concentration (Tmax) of BMS-986016

    Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

  • Trough observed serum concentration (Ctrough) of BMS-986016

    Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

  • Concentration at the end of a dosing interval (Ctau) of BMS-986016

    Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

  • Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016

    Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

  • +13 more secondary outcomes

Study Arms (2)

Monotherapy

EXPERIMENTAL

Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation

Drug: Relatlimab

Combination Therapy

EXPERIMENTAL

Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation

Drug: RelatlimabDrug: Nivolumab

Interventions

RelatlimabDRUG

Specified dose on specified days

Also known as: BMS-986016
Combination TherapyMonotherapy
NivolumabDRUG

Specified dose on specified days

Also known as: BMS-936558, Opdivo
Combination Therapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Kashiwa-shi, Chiba, 2778577, Japan

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

relatlimabNivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

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

November 1, 2016

First Posted

November 17, 2016

Study Start

January 4, 2017

Primary Completion

July 9, 2024

Study Completion

July 9, 2024

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations

JP(1)