RP1 for Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Squamous Cell Carcinoma+2 MoreRP1 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if cemiplimab monotherapy is better than cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC.

Eligible Conditions
  • Squamous Cell Carcinoma
  • Skin Squamous Cell Carcinoma

Treatment Effectiveness

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: up to 5 years

3 years
3-year survival
approximately 26 months
Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)
approximately 30 months
Change in overall scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
up to 5 years
Complete Response Rate (CRR) according to blinded independent review
Duration of Response (DOR) per investigator review
Duration of Response (DOR) per investigator review and blinded independent review
ORR/CRR by investigator assessment
ORR/CRR by investigator assessment and blinded independent review
ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy
ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review
Advance Directives
ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review
Objective Response Rate (ORR) according to blinded independent review
Overall Survival (OS)
Progression Free Survival (PFS) by blinded independent review.
Progression-free Survival (PFS) per investigator review

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Cemiplimab
1 of 2
Cemiplimab in combination with RP1
1 of 2

Active Control

Experimental Treatment

180 Total Participants · 2 Treatment Groups

Primary Treatment: RP1 · No Placebo Group · Phase 2

Cemiplimab in combination with RP1Experimental Group · 2 Interventions: RP1, Cemiplimab · Intervention Types: Biological, Drug
Cemiplimab
Drug
ActiveComparator Group · 1 Intervention: Cemiplimab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Replimune Inc.Lead Sponsor
4 Previous Clinical Trials
524 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
548 Previous Clinical Trials
199,763 Total Patients Enrolled
Claudia Andreu Vieyra, PhDStudy DirectorLead Medical Monitor
Jeannie Hou, MDStudy DirectorSecondary Medical Monitor
2 Previous Clinical Trials
365 Total Patients Enrolled
Sumera Raoof, MDStudy DirectorLead Medical Monitor

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
All patients must agree to allow their tumor specimens to be archived or newly obtained for central pathology review to confirm the diagnosis of squamous cell carcinoma.
is required for each patient enrolled Each patient must have at least 1 lesion that meets the study's injection criteria.
The patient can expect to live for more than 12 weeks.
may be eligible for MAB Patients with advanced cancer that has spread to other parts of their body and who are not suitable candidates for surgery or radiation therapy may be eligible for MAB
Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the CSCC disease under study.
A histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma.