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Immunotherapy + Cryoablation for Pediatric Solid Cancers

Phase 2
Waitlist Available
Led By AeRang Kim, MD, PhD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate normal organ and marrow function as defined below
Therapeutic options: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Who is the study for?
This trial is for pediatric and young adult patients aged between 1 and less than 40 years with relapsed or refractory solid tumors, including osteosarcoma and Ewing sarcoma. Participants must have measurable disease, be candidates for cryoablation therapy, and have no other curative treatment options available. They should not be part of another clinical study or have unresolved severe side effects from previous treatments.Check my eligibility
What is being tested?
The trial investigates the effectiveness of combining cryoablation therapy (freezing cancer cells) with two immune checkpoint inhibitors: nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4). It's a phase II study where all participants receive this combination to see how well it works against various solid tumors in children and young adults.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in different organs, skin issues like rash or itching, hormonal gland problems which could affect energy levels, digestion etc., flu-like symptoms, muscle pain, infusion reactions during treatment administration, possible liver inflammation leading to jaundice or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs and bone marrow are functioning well.
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My cancer came back or didn't respond after initial treatment meant to cure it.
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I have recovered from side effects of my previous cancer treatments.
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I or my guardian can sign the consent form.
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My cancer returned or didn't respond to initial treatment, and no other cure is available.
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I am between 1 and 40 years old.
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My cancer is a confirmed solid tumor like osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma.
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I am mostly active and can do things for myself.
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I have at least one tumor that can be treated with freezing therapy.
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I have at least two tumors that can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease response measured with consistent imaging utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Incidence and severity of study treatment-related adverse events measured by the Common Terminology Criteria for Adverse Events (CTCAE) v. 5
Secondary outcome measures
Biomarkers of response to checkpoint inhibition (number/activity of immune cells, cytokines, chemokines, C-reactive protein) will be measured in peripheral blood by flow cytometry at baseline and throughout study
Disease response in rare tumors (non-statistical cohort) measured with consistent imaging utilizing the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)
Health outcomes as assessed by the PROMIS® Pediatric Scale v1.0 Global Health 7+2 scores at baseline, prior to start of each cycle, and last trial visit
+1 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: All patientsExperimental Treatment3 Interventions
Patients less than 40 years old with relapsed/refractory solid tumors and at least 2 sites of measurable disease will receive the current pediatric RP2D of nivolumab and ipilimumab for one cycle and undergo cryoablation therapy of one tumor site. Patients will continue to receive cycles of checkpoint inhibition as long as there is no disease progression of unacceptable toxicity (maximum of 13 cycles [12 months]). There are 4 patient cohorts: Osteosarcoma Ewing sarcoma Rhabdomyosarcoma All other solid tumors (non-statistical)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
209 Previous Clinical Trials
207,740 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,531 Total Patients Enrolled
1 Trials studying Osteosarcoma
21 Patients Enrolled for Osteosarcoma
AeRang Kim, MD, PhDPrincipal InvestigatorChildren's National Research Institute
5 Previous Clinical Trials
71 Total Patients Enrolled
2 Trials studying Osteosarcoma
16 Patients Enrolled for Osteosarcoma

Media Library

Cryoablation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05302921 — Phase 2
Osteosarcoma Research Study Groups: All patients
Osteosarcoma Clinical Trial 2023: Cryoablation Therapy Highlights & Side Effects. Trial Name: NCT05302921 — Phase 2
Cryoablation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05302921 — Phase 2
Osteosarcoma Patient Testimony for trial: Trial Name: NCT05302921 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Minnesota
What site did they apply to?
Children's National Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Yes , How long the tria will take place. Do we have to pay for our travel , logistics and accomodations?
PatientReceived no prior treatments

Why did patients apply to this trial?

We are looking for Clinical trial, Priyakshi already undergone VAC & VDC followed by Pazopanib and Everlomus. Currently under medication for TRAMETINIB.
PatientReceived no prior treatments
~2 spots leftby Jul 2025