Your session is about to expire
← Back to Search
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer has spread to distant parts of my body.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images
Incidence of Adverse Events
Overall Response Rate
+3 moreOther outcome measures
Utility of CT-based radiomics
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 2
~2010
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,354 Total Patients Enrolled
Jason J LukePrincipal InvestigatorAlliance for Clinical Trials in Oncology
3 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood urea nitrogen level should be less than or equal to 30 mg/dl.Your diastolic blood pressure is less than or equal to 90 mm Hg.I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.I can take care of myself and am up and about more than half of my waking hours.Your body has enough white blood cells called neutrophils.You have a platelet count of at least 100,000 per cubic millimeter.Your total bilirubin level is less than or equal to 2.0 mg/dl.Your albumin levels are higher than 3 mg/dl.I have at least two cancerous areas; one can be measured and one qualifies for a specific radiation treatment.I've had palliative radiotherapy for cancer spread outside the brain but have 2 untreated cancer spots.I've had specific scans to show cancer spread within the last 45 days.I do not have any other cancer that could affect my treatment.Your hemoglobin level is at least 9.0 grams per deciliter.My cancer has spread to distant parts of my body.Your creatinine level in the blood is no higher than 1.7 mg/dl.Your systolic blood pressure is lower than or equal to 150 mm Hg.My diagnosis of Merkel cell carcinoma was confirmed by a pathology review.People with HIV can participate if their CD4 count is 350 mm^3 or higher and their HIV viral load is less than 25,000 IU/ml.Your AST and ALT levels are not more than three times the normal limit.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (pembrolizumab)
- Group 2: Group II (pembrolizumab, SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger