Your session is about to expire
← Back to Search
Immunotherapy + Cryoablation for Pediatric Solid Cancers
Study Summary
This trial is studying whether a combination of two immunotherapy drugs, nivolumab and ipilimumab, can help to shrink solid tumors in children and young adults.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have or had an autoimmune or inflammatory disorder.My organs and bone marrow are functioning well.I do not have any unmanaged ongoing illnesses.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.My cancer came back or didn't respond after initial treatment meant to cure it.I have not received a live vaccine in the last 30 days.I have had another type of cancer.I have recovered from side effects of my previous cancer treatments.I have cancer that has spread to my brain or spinal cord.I or my guardian can sign the consent form.I am not currently on any cancer treatments like chemotherapy or hormone therapy.My cancer returned or didn't respond to initial treatment, and no other cure is available.You have had an organ transplant from someone else.You have a history of a weak immune system that has caused ongoing health issues.I do not have active infections like TB, hepatitis B or C, or HIV.I am not pregnant, breastfeeding, and willing to use birth control if of childbearing potential.I am between 1 and 40 years old.My cancer is a confirmed solid tumor like osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma.I have not taken immunosuppressive drugs in the last 14 days.I am mostly active and can do things for myself.I have at least one tumor that can be treated with freezing therapy.I have not had major surgery in the last 28 days.I have never stopped an immunotherapy treatment because of severe side effects.I may have had any number of chemotherapy treatments before.I have at least two tumors that can be measured.
- Group 1: All patients
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Who is eligible to join this research project?
"This clinical trial is accepting 42 participants suffering from rhabdomyosarcoma, ranging in age between 1 and 39. Eligibility criteria includes the following: a Karnofsky score of at least 50% for those 16 or older, Lansky performance score of 60% or higher for minors under 16, full recovery from any prior chemotherapy treatments at least 21 days before study entry, two measurable/evaluable solid target lesions upon evaluation, one tumor available to receive cryoablation therapy and consent from either patient (if above legal age) or guardian/parent. Furthermore, histologically confirmed osteosarcoma, E"
What objectives are the scientists hoping to accomplish through this trial?
"This medical study's primary aim is to assess the occurrence and magnitude of treatment-related side effects using CTCAE v. 5 over a period of 12 months. Additionally, biomarkers associated with checkpoint inhibition will be observed in patient blood via flow cytometry at baseline and during the trial, alongside PROMIS® Pediatric Scale v1.0 Global Health 7+2 scores for health outcomes pre-cycle start and last visit, as well as Parent Proxy Scale v1.0 Global Health 7+2 ratings at all points mentioned previously."
Has the Food and Drug Administration officially certified Nivolumab for public use?
"Nivolumab's safety is rated as a 2 by our team at Power due to the fact that this Phase 2 trial has yielded data affirming it protection but not its efficacy."
Is it still possible to enroll in this clinical research project?
"According to clinicialtrials.gov, this clinical trial has been ongoing since February 18th 2022 and is actively searching for participants. The study was last updated on March 21st of the same year."
Does this exploration include geriatric participants?
"In order to be considered for this investigation, the patient must be below 40 years old. Currently, there are 575 studies accepting minors under 18 and 3327 studies enrolling seniors above 65."
How many participants have been enrolled in this experiment?
"Indeed, data from clinicaltrials.gov reveals that this experiment is currently recruiting patients. Initially released on February 18th 2022 and most recently updated on March 21st 2022, the study requires 42 participants to be recruited across 1 location."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
Share this study with friends
Copy Link
Messenger