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Nivolumab + Radiation Therapy / Ipilimumab for Cancer
Phase 1
Waitlist Available
Led By Claire Verschraegen, MD
Research Sponsored by Claire Verschraegen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post treatment
Awards & highlights
Study Summary
This trial is studying nivolumab given with radiation therapy or ipilimumab to see how well it works and what side effects it causes in treating patients with Merkel cell cancer.
Who is the study for?
This trial is for patients with Merkel cell cancer who've had surgery to remove it and are at high risk of recurrence. They must be in good physical condition, not have metastatic disease or a history of certain cancers, no recent immunosuppressive treatments, and agree to use contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of nivolumab (an immune system booster) combined with radiation therapy or ipilimumab (another immune booster) as additional treatment post-surgery. It aims to see if these therapies can prevent cancer from returning.See study design
What are the potential side effects?
Potential side effects include fatigue, skin reactions from radiation, autoimmune reactions like inflammation in various organs due to nivolumab or ipilimumab, and typical risks associated with monoclonal antibody therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), assessed up to one and half years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), assessed up to one and half years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients completing 12 months of treatment
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival at three years
Recurrence-free survival (RFS) one and half years
Other outcome measures
T cell analysis
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nivolumab, radiation therapy)Experimental Treatment2 Interventions
Patients receive nivolumab IV over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (nivolumab, ipilimumab)Active Control2 Interventions
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Claire VerschraegenLead Sponsor
Claire Verschraegen, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
8 Previous Clinical Trials
165 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has spread to distant parts of the body.You have had active tuberculosis in the past.You have had an organ transplant or are currently being treated for certain types of blood cancers.You have already received chemotherapy or radiation therapy for Merkel cell carcinoma (MCC) treatment.You are taking strong medications that weaken your immune system within 2 weeks before the study.Your hemoglobin level is at least 8 grams per deciliter.Your kidney function is good, and your creatinine levels are within a certain range.Your cancer has spread to the lymph nodes and you have a tumor that is larger than 2 cm, or has certain features that increase the risk of the cancer spreading.If you have HIV, your viral load must be undetectable and your CD4+ T-cell counts must be 350 cells/uL or higher.Your kidney function needs to be checked according to the hospital's guidelines.You are able to perform regular daily activities without any issues or with some limitations due to your health.Your blood test shows that you have enough infection-fighting white blood cells.Your platelet count is at least 100,000 per microliter of blood without needing a transfusion in the past week.You have an autoimmune disease that needed strong medication in the past 2 years. This doesn't include taking replacement therapy for certain conditions like thyroid or adrenal problems.You have an ongoing infection that needs to be treated with medication given through a vein.Your bilirubin levels in your blood are within a certain range, unless you have Gilbert Syndrome, in which case it can be slightly higher.Your liver enzyme levels should be within a certain range when tested before starting the treatment.Women who can have children need to have a negative pregnancy test before starting the study and regularly during treatment. If the urine test shows a possible pregnancy, a blood test will be needed.You have taken certain immunotherapy drugs in the past.You have a history of certain types of cancer, but you may still be eligible if the cancer has been treated and in remission for a certain period of time, or if you are currently receiving specific hormonal therapies for breast or prostate cancer.You have serious heart problems that are not under control, or a history of heart attack within the last 6 months.You have a current infection of hepatitis B or hepatitis C.You have cancer that has spread to nearby lymph nodes or has grown outside the normal boundaries.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (nivolumab, radiation therapy)
- Group 2: Arm II (nivolumab, ipilimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any prior experiments which have incorporated Radiation Therapy?
"Currently, there are 764 active clinical trials researching the efficacy of Radiation Therapy. Of these studies, 86 have progressed to Phase 3 and can be conducted at 42752 medical centres across the United States, with a particular concentration in Pittsburgh Pennsylvania."
Answered by AI
To what extent does Radiation Therapy pose a risk to human health?
"Because it is currently in Phase 1, there is limited clinical data supporting the safety and efficacy of Radiation Therapy. As such, our team at Power assigned it a score of 1 on their scale from 1 to 3."
Answered by AI
How many individuals can participate in the research study?
"Currently, this trial is not accepting new participants. The study was initially posted on January 7th 2019 with the last update taking place on April 25th 2022. However, if you are seeking other investigations, there are 2478 studies actively enrolling patients suffering from carcinoma or neuroendocrine and 764 trials recruiting individuals for Radiation Therapy treatments."
Answered by AI
In what medical scenarios is Radiation Therapy typically utilized?
"Radiation Therapy is a commonly employed anti-angiogenic therapy, however its potential applications extend beyond that. It can also be used to treat malignant neoplasms, unresectable melanoma and squamous cell carcinoma."
Answered by AI
Are there any available slots in this research endeavor for participants?
"According to what is published on clinicaltrials.gov, this specific medical trial is not currently accepting participants. Initially posted on the 7th of January 2019 and last updated 25 April 2022, this study has reached its recruitment capacity at present. Nevertheless, 3242 other studies are actively enrolling patients for their trials."
Answered by AI
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