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REGN6569 for Oral Squamous Cell Carcinoma

Phase-Based Progress Estimates

Effectiveness

Safety

Oral Squamous Cell Carcinoma+5 More

REGN6569 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is evaluating the safety and efficacy of REGN6956 as monotherapy and in combination with cemiplimab. The primary objective is to assess the safety and tolerability of the combination. Secondary objectives include assessing the preliminary efficacy of the combination as measured by objective response rate, disease control rate, duration of response, progression-free survival, and overall survival.

Eligible Conditions

Oral Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Hypopharyngeal Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Oral Squamous Cell Carcinoma

GEN-001

Intrathecal Resiniferatoxin

Pembrolizumab

Study Objectives

7 Primary · 9 Secondary · Reporting Duration: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

Up to 42 days

Incidence of dose-limited toxicities (DLTs)

Month 30

Disease control rate (DCR)

Drug concentrations of REGN6569 in serum

Drug concentrations of cemiplimab in serum

Duration of Response (DOR)

Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569

Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab

Incidence and severity of adverse events of special interest (AESIs)

Incidence and severity of grade ≥3 laboratory abnormalities

Incidence and severity of serious adverse events (SAEs)

Incidence and severity of treatment emergent adverse events(TEAEs)

ORR

Objective response rate (ORR)

Overall survival (OS)

Percentage change in glucocorticoid-induced tumor necrosis factor receptor-Related(GITR)+ Treg density

Progression-free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Other trials for Oral Squamous Cell Carcinoma

GEN-001

Intrathecal Resiniferatoxin

Pembrolizumab

Trial Design

1 Treatment Group

REGN6569+cemiplimab

1 of 1

Experimental Treatment

85 Total Participants · 1 Treatment Group

Primary Treatment: REGN6569 · No Placebo Group · Phase 1

REGN6569+cemiplimabExperimental Group · 2 Interventions: REGN6569, Cemiplimab · Intervention Types: Drug, Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: up to 90 days after the last dose of regn6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

543 Previous Clinical Trials

199,563 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

223 Previous Clinical Trials

88,354 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You have no history of ICB therapy.

You have a disease for which there is no approved treatment option.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References