A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab

NCT ID: NCT04112498

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-02-27

Brief Summary

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This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nivolumab + relatlimab + rHuPH20

Group Type EXPERIMENTAL

relatlimab

Intervention Type DRUG

Specified dose on Specified days

nivolumab

Intervention Type DRUG

Specified dose on Specified days

rHuPH20

Intervention Type DRUG

Specified dose on Specified days

Interventions

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relatlimab

Specified dose on Specified days

Intervention Type DRUG

nivolumab

Specified dose on Specified days

Intervention Type DRUG

rHuPH20

Specified dose on Specified days

Intervention Type DRUG

Other Intervention Names

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Opdivo Enhanze

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic confirmation of (unresectable and/or metastatic) advanced solid tumors
* Melanoma
* Metastatic squamous or non- squamous non-small cell lung cancer (NSCLC)
* Gastric adenocarcinoma (includes gastro-esophageal junction)
* Hepatocellular carcinoma (HCC)
* Squamous cell carcinoma of the head and neck (SCCHN)
* Renal cell carcinoma (RCC)
* Bladder cancer
* Participants must have received available standard therapies
* Women and men must agree to follow instructions for method of contraception
* Measureable disease as per RECIST version 1.1 criteria
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

* Participants must not have active brain metastases or leptomeningeal metastases
* Participants with HCC must not have any history of hepatic encephalopathy, any prior (within 1 year) or current clinically significant ascites
* History of allergy or hypersensitivity to study drug components
* Participants with serious or uncontrolled cardiovascular disease
* Excluding patients with serious or uncontrolled medical disorders
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
* Participants with an active, known, or suspected autoimmune disease
* Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Local Institution - 0001

Hackensack, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA224-087

Identifier Type: -

Identifier Source: org_study_id

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