Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    669
  • sponsor
    Regeneron Pharmaceuticals
Updated on 26 April 2022
lymphoma
measurable disease
bone marrow procedure
pd-l1
primary cancer

Summary

The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma.

The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).

Details
Condition Malignancies
Treatment REGN2810, REGN3767, Cemiplimab
Clinical Study IdentifierNCT03005782
SponsorRegeneron Pharmaceuticals
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease
Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor
Eastern Cooperative Oncology Group performance status of 0 or 1
Adequate organ and bone marrow function

Exclusion Criteria

Prior treatment with any LAG-3 targeting biologic or small molecule
Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation
Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease
Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
Myocardial infarction within 6 months
Note: Other protocol defined Inclusion / Exclusion criteria apply
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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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