Cemiplimab-Rwlc for Cutaneous Neuroendocrine Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cutaneous Neuroendocrine CarcinomaCemiplimab-Rwlc - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a new cancer drug is safe and effective in treating Merkel Cell Carcinoma.

Eligible Conditions
  • Cutaneous Neuroendocrine Carcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 3 years

Year 3
Number of Participants With Adverse Events Related to Study Treatment
Up to 3 years
Overall Survival
Relapse Free Survival

Trial Safety

Trial Design

1 Treatment Group

Neoadjuvant Cemiplimab Treatment
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Cemiplimab-Rwlc · No Placebo Group · Phase 1

Neoadjuvant Cemiplimab Treatment
Drug
Experimental Group · 1 Intervention: Cemiplimab-Rwlc · 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 3 years

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
549 Previous Clinical Trials
200,333 Total Patients Enrolled
Sanofi-SynthelaboIndustry Sponsor
49 Previous Clinical Trials
34,636 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
504 Previous Clinical Trials
125,983 Total Patients Enrolled
Ahmad Tarhini, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
5 Previous Clinical Trials
134 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically proven Merkel cell carcinoma.
You have clinical stage I-II MCC (AJCC 8th edition) either newly diagnosed or previously diagnosed with recent disease recurrence.
Patients must be considered candidates for wide local surgical excision and may be candidates for sentinel lymph node biopsy.
You are willing to comply with all study procedures and are available for the duration of the study.