Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory So… (NCT02304458) | Clinical Trial Compass
CompletedPhase 1/2
Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas
United States, Canada140 participantsStarted 2015-03-30
Plain-language summary
This phase I/II trial studies the side effects and best dose of nivolumab when given with or without ipilimumab to see how well they work in treating younger patients with solid tumors or sarcomas that have come back (recurrent) or do not respond to treatment (refractory). 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. It is not yet known whether nivolumab works better alone or with ipilimumab in treating patients with recurrent or refractory solid tumors or sarcomas.
Who can participate
Age range
12 Months – 30 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:
* Parts A \& C: patients must be \>= 12 months and \< 18 years of age at the time of study enrollment
* Parts B1-B6, B8, D1-D6, E3, E4: patients must be \>= 12 months and =\< 30 years of age at the time of study enrollment
* Part B7: patients must be \>= 12 months and \< 18 years of age at the time of study enrollment
* Patients must have had histologic verification of malignancy at original diagnosis or relapse
* Parts A \& C: patients with recurrent or refractory solid tumors, without central nervous system (CNS) tumors or known CNS metastases, are eligible; note: CNS imaging for patients without a known history of CNS disease is only required if clinically indicated
* Part B1: patients with relapsed or refractory neuroblastoma
* Part B2: patients with relapsed or refractory osteosarcoma
* Part B3: patients with relapsed or refractory rhabdomyosarcoma
* Part B4: patients with relapsed or refractory Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET)
* Part B5: patients with relapsed or refractory Hodgkin lymphoma
* Part B6: patients with relapsed or refractory non-Hodgkin lymphoma
* Part B7: patients with unresectable melanoma or metastatic melanoma or relapsed melanoma or refractory melanoma
* Part B8: Patients with relapsed or refractory neuroblastoma (MIBG evaluable disease without Response Evaluation Criteria in Solid Tumors \[RECIST\] measurable lesion)
* Once the dose-escalation portion of Part A is completed, c…
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
Frequency of Dose Limiting Toxicities of Nivolumab as a Single Agent or in Combination With Ipilimumab
Timeframe: 28 days
2
Antitumor Effect of Nivolumab as a Single Agent or in Combination With Ipilimumab