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Checkpoint Inhibitor

Immunotherapy + Radiation for Cancer

Phase 2

Waitlist Available

Led By Jason J Luke

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

Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative pregnancy test done =< 28 days prior to registration is required

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying two different ways to give pembrolizumab (with or without stereotactic body radiation therapy) to see how well it works in treating patients with Merkel cell cancer that has spread to other places in the body.

Who is the study for?

This trial is for adults with advanced Merkel Cell Carcinoma (MCC) who are in fairly good health, as shown by their ECOG status and normal organ function tests. They must have at least two cancerous deposits suitable for the study treatments and cannot be pregnant or nursing. People with HIV can join if they meet certain health criteria.

What is being tested?

The trial is testing whether adding Stereotactic Body Radiation Therapy to Pembrolizumab, an immunotherapy drug, improves outcomes in patients with MCC. Participants will either receive just Pembrolizumab or both treatments together to see which works better.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation of organs, fatigue, skin reactions, and flu-like symptoms. The radiation therapy could lead to localized skin irritation and damage to nearby tissues or organs.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.

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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 cancer has spread to distant parts of my body.

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My diagnosis of Merkel cell carcinoma was confirmed by a pathology review.

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

Progression-free Survival (PFS)

Secondary study objectives

Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images

Incidence of Adverse Events

Overall Response Rate

+3 more

Other study objectives

Utility of CT-based radiomics

Awards & Highlights

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: Group II (pembrolizumab, SBRT)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

Group II: Group I (pembrolizumab)Active Control1 Intervention

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790