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OpenTrials
Completed

NCT Number: NCT04112498

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

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Hackensack, New Jersey, 07601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Other protocol defined inclusion/exclusion Criteria could apply

Treatment and study plan

Relatlimab

Drug

Specified dose on Specified days

Nivolumab

Drug

Specified dose on Specified days

Other names: Opdivo

rHuPH20

Drug

Specified dose on Specified days

Other names: Enhanze

Primary outcomes

  1. maximum observed serum concentration (Cmax)

    Time frame: approximately 60 days

  2. time of maximum observed serum concentration (Tmax)

    Time frame: approximately 60 days

  3. area under the time-concentration curve over the dosing interval AUC (TAU)

    Time frame: approximately 60 days

  4. Observed concentration at the end of the dosing interval (Ctau)

    Time frame: approximately 60 days

  5. Incidence of Serious Adverse Events (SAEs)

    Time frame: approximately 2 years

  6. Incidence of Adverse Events (AEs)

    Time frame: approximately 2 years

  7. Incidence of Adverse Events leading to discontinuation

    Time frame: approximately 2 years

  8. Number of deaths

    Time frame: approximately 2 years

  9. Number of laboratory abnormalities

    Time frame: approximately 2 years

Secondary outcomes

  1. Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction

    Time frame: approximately 2 years

  2. Number of events within the hypersensitivity/infusion reaction select AE category

    Time frame: approximately 2 years

  3. Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable)

    Time frame: approximately 2 years

  4. Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable)

    Time frame: approximately 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2019
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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