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
Effectiveness Progress
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
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: DrugTreatment
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.
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Conditions
Cancer Related
Treatments