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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • The subject must sign and date the IRB/IEC-approved written ICF prior to the performance of any study-related procedures that are not considered part of standard of care. b) Consent for tumor biopsy samples i) Parts A and B (Dose Escalation): (1) During the screening period, all participants must have tumor tissue submitted, either a recent archival sample (obtained within 3 months of enrollment and with no intervening systemic anticancer treatment between time of acquisition and enrollment) or a fresh pretreatment biopsy. Subjects who do not meet these criteria are not eligible. However, subjects whose screening biopsy yields inadequate tissue quantity or quality will not be ineligible on this basis alone. The acquisition of existing formalin-fixed paraffin-embedded (FFPE) tumor tissue, either a block or unstained slides, for performance of correlative studies should also be collected if available. Subjects unable to provide pretreatment tumor tissue or who do not have accessible lesions are not eligible.
  • Parts A1, C, D, and E (Cohort Expansions): (1) During the screening period, all participants must have tumor tissue submitted, either a recent archival sample (obtained within 3 months of enrollment and with no intervening systemic anticancer treatment between time of acquisition and enrollment) or a fresh pretreatment biopsy. Subjects who do not meet these criteria are not eligible. However, subjects whose screening biopsy yields inadequate tissue quantity or quality will not be ineligible on this basis alone. The acquisition of existing FFPE tumor tissue, either a block or unstained slides, for performance of correlative studies should also be collected if available. Subjects unable to provide pretreatment tumor tissue or who do not have accessible lesions are not eligible.
  • 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 subjects in 1st line cohorts.
  • ECOG performance status of 0 or 1.
  • 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.

Eligibility last updated 9/29/21. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Block, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
.

Mayo Clinic Footer