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Cemiplimab for Merkel Cell Carcinoma

Phase 1

Recruiting

Led By Ahmad Tarhini, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance Status of 0, 1, or 2

Histologically proven diagnosis of Merkel cell carcinoma (MCC)

Must not have

Patients with hematologic malignancies (eg, chronic lymphocytic leukemia [CLL])

Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

This trial is for adults with newly diagnosed or recurrent Stage I-II Merkel Cell Carcinoma, or advanced Cutaneous Squamous Cell Carcinoma. Candidates must be fit for surgery, have an ECOG status of 0-2, and agree to use effective contraception if applicable. Excluded are those with other recent cancers, certain immune conditions, severe allergies to cemiplimab components, and uncontrolled infections.

What is being tested?

The study tests the safety and effectiveness of Cemiplimab-Rwlc when given before tumor removal surgery in treating Merkel Cell Carcinoma and Cutaneous Squamous Cell Carcinoma. Participants will receive Cemiplimab prior to their scheduled surgeries.

What are the potential side effects?

Cemiplimab may cause side effects such as fatigue, skin reactions at the injection site, muscle aches, possible immune-related issues like inflammation in organs (including lungs), allergic reactions similar to past antibody treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My condition is confirmed as Merkel cell carcinoma.

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My Merkel cell carcinoma is in stage I or II.

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I have stage II to IV CSCC in sensitive areas or other parts and surgery is planned.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood cancer, such as chronic lymphocytic leukemia.

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I stopped taking cancer immune therapy because of its side effects.

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I have had a stem cell transplant from a donor or myself.

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I have had a solid organ transplant.

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I haven't been hospitalized for an infection or needed IV antibiotics in the last 2 weeks.

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I have active tuberculosis.

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I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.

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I have received immunotherapy for Merkel cell carcinoma.

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I have had lung conditions treated with high-dose steroids.

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I am allergic to ingredients in the cemiplimab medication.

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I do not have an uncontrolled HIV, HBV, or HCV infection.

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I haven't taken high doses of steroids in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Adverse Events Related to Study Treatment

Secondary study objectives

Overall Survival

Relapse Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant Cemiplimab TreatmentExperimental Treatment1 Intervention

Participants will receive cemiplimab 350 mg IV at least 3 weeks prior to surgical resection. After surgery they will continue to receive 350 mg cemiplimab every 3 weeks for up to 8 additional doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab-Rwlc

2019

Completed Phase 2

~40

0 / 16Eligibility criteria met