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

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Updated on 26 April 2022

See if I qualify

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 Identifier	NCT03005782
Sponsor	Regeneron Pharmaceuticals
Last Modified on	26 April 2022

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