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Checkpoint Inhibitor

Pembrolizumab for Skin Cancer

Phase 3

Waitlist Available

Led By Janice Mehnert

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients with distant metastatic disease (stage IV) are ineligible.

Cancers of unknown primary that have regional disease only are eligible.

Must not have

Patients must not be on active immunosuppression, have a history of life threatening virus, have had other (beside non-melanoma skin cancers, or recent indolent cancers e.g.: resected low grade prostate cancer) invasive cancer diagnoses in the last two years, or have had immunotherapy of any kind within the last 2 years prior to randomization.

Operative notes from patient's surgical resection must be accessible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares pembrolizumab to observation in treating patients with resected Merkel cell cancer. Pembrolizumab is an immunotherapy that may help the body's immune system attack the cancer.

Who is the study for?

Adults with stage I-IIIb Merkel cell carcinoma, surgically removed within the past 16 weeks. Must have stable blood counts and organ function, no HIV or hepatitis unless under control. Not for those with distant metastases, history of other cancers in last two years (except certain skin cancers), or recent immunotherapy.

What is being tested?

The trial is testing if pembrolizumab (an immune system booster) is better than just watching patients after surgery for Merkel cell cancer. Patients are randomly chosen to get either pembrolizumab or standard observation post-surgery.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation in organs, infusion reactions, fatigue, and possibly increase infection risk. Specific side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has not spread to distant parts of my body.

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My cancer's origin is unknown but it has spread to nearby areas only.

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My sentinel lymph node biopsy was not negative.

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I am 18 years old or older.

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My diagnosis of Merkel cell carcinoma is confirmed and is stage I-IIIb.

Exclusion Criteria

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

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I am not on immunosuppressants, haven't had severe viruses, other recent cancers except for non-melanoma skin or low-grade prostate cancer, or immunotherapy in the last 2 years.

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I can provide the surgical notes from my cancer surgery.

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I have never needed steroids for non-infectious lung inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Recurrence free survival (RFS)

Secondary study objectives

Impact of radiation therapy on OS

Impact of radiation therapy on RFS

Impact of radiation therapy on distant metastasis free survival (DMFS)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (pembrolizumab, radiation therapy)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT, CT, or MRI throughout the trial. Patients may also undergo blood sample collection as clinically indicated at the discretion of the treating investigator.

Group II: Arm B (standard of care observation, radiation therapy)Active Control6 Interventions

Patients receive standard of care observation every 3 months for 1 year, and then every 6 months for 5 years. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1. Patients undergo PET-CT, CT, or MRI throughout the trial. Patients may also undergo blood sample collection as clinically indicated at the discretion of the treating investigator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Pembrolizumab

2017

Completed Phase 3

~3150