Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merke… (NCT03798639) | Clinical Trial Compass
CompletedPhase 1
Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer
United States7 participantsStarted 2019-01-07
Plain-language summary
This phase I trial studies the side effects and how well nivolumab works when given together with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be willing and able to understand and give written informed consent and comply with all study related procedures
* All patients should undergo definitive surgical resection, including when possible sentinel lymph node dissection
* Patients must have recovered after any recent surgery and be ambulatory
* Have node positive disease (stage pIIIA or pIIIB) +/- extracapsular extension
* Have node negative disease and any of the following high risk features
* Tumor size \>= 2 cm
* Margins =\< 1-2 cm and re-resection is not possible
* Evidence of perineural or lymphovascular invasion
* Human immunodeficiency virus (HIV) patients with undetectable viral load and CD4+ T-cell counts \>= 350 cells/uL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Absolute neutrophil count (ANC) \>= 1,500/mcL (performed within 16 days of treatment initiation)
* Platelets \>= 100,000/mcL in the absence of transfusion support within 7 days of determining eligibility (performed within 16 days of treatment initiation)
* Hemoglobin \>= 8 g/dL (performed within 16 days of treatment initiation)
* Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance \>= 40 mL/min creatinine clearance (performed within 16 days of treatment initiation) (Glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])
* Creatinine clearance should be calculated per institutional stan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients completing 12 months of treatment