280 Participants Needed

Pembrolizumab for Skin Cancer

Recruiting at 644 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients must not be on active immunosuppression, which might imply some restrictions on certain medications. It's best to discuss your specific medications with the trial team.

Is pembrolizumab safe for humans?

Pembrolizumab, also known as KEYTRUDA, has been studied for safety in patients with melanoma and other cancers. Common side effects include fatigue, cough, nausea, itching, rash, decreased appetite, joint pain, and diarrhea. Some patients may experience immune-related side effects like lung inflammation, liver inflammation, and thyroid issues.12345

How is the drug pembrolizumab unique for treating skin cancer?

Pembrolizumab is unique because it is a PD-1 inhibitor that helps the immune system attack cancer cells by blocking a pathway that usually stops immune cells from working effectively. This drug has shown durable antitumor activity in various cancers, including skin cancer, with manageable side effects.45678

What data supports the effectiveness of the drug pembrolizumab for skin cancer?

Pembrolizumab has shown meaningful and lasting antitumor effects in patients with recurrent or metastatic cutaneous squamous cell carcinoma, a type of skin cancer, with manageable side effects.45678

Who Is on the Research Team?

JM

Janice Mehnert

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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

I have hepatitis B or C, but my viral load is undetectable or I am on suppressive therapy.
Creatinine =< 2.0 x institutional upper limit of normal (ULN) (within 4 weeks prior to randomization).
I have Merkel cell carcinoma and haven't had systemic or radiation therapy before surgery, or I finished adjuvant radiation less than 6 weeks ago.
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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 will use or am using effective birth control or abstaining from sex while on Pembrolizumab.
Patient must not be pregnant or breast-feeding due to the unknown effects of the study drug in this setting. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab IV every 21 days for up to 17 cycles or undergo standard of care observation

Approximately 12 months
Every 21 days for pembrolizumab arm; every 3 months for observation arm

Radiation

Participants may undergo standard of care radiation therapy within 14 days of day 1, cycle 1

Concurrent with initial treatment phase

Follow-up

Participants are monitored for recurrence free survival and overall survival

Up to 5 years
Every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (pembrolizumab, radiation therapy)Experimental Treatment6 Interventions
Group II: Arm B (standard of care observation, radiation therapy)Active Control6 Interventions

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

🇺🇸
Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.
In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma.Hersey, P., Gowrishankar, K.[2017]

Citations

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Pembrolizumab: first global approval. [2021]
Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): an open-label, nonrandomized, multicenter, phase II trial. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]
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