REGN6569 for Oral Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oral Squamous Cell Carcinoma+5 More
REGN6569 - Drug
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

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

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 preview

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.