Pembrolizumab for Skin Cancer

Recruiting in Palo Alto (17 mi)

+632 other locations

Overseen ByJanice Mehnert

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Eligibility Criteria

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.

Inclusion Criteria

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

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

My sentinel lymph node biopsy was not negative.

I am 18 years old or older.

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

Exclusion Criteria

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.

I can provide the surgical notes from my cancer surgery.

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

Participant Groups

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.

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 and urine 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 and urine sample collection as clinically indicated at the discretion of the treating investigator.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: