An Investigational Immuno-therapy Study to Assess the Safety Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    1500
  • sponsor
    Bristol-Myers Squibb
Updated on 25 January 2021
carcinoma
treatment regimen
primary cancer

Summary

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

Details
Condition Cancer, Neoplasms by Site, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neoplasms
Treatment Nivolumab, Relatlimab, BMS-986213
Clinical Study IdentifierNCT01968109
SponsorBristol-Myers Squibb
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4
For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts
ECOG performance status between 0 and 2
At least 1 lesion with measurable disease at baseline
Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)

Exclusion Criteria

Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
Autoimmune disease
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Uncontrolled CNS metastases
Other protocol defined inclusion/exclusion criteria could apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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