Neoadjuvant Dual Checkpoint Inhibition and Cryoablation in Relapsed/Refractory Pediatric Solid Tumors

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

February 18, 2022

Primary Completion Date

March 12, 2024

Study Completion Date

March 12, 2024

Conditions
OsteosarcomaEwing SarcomaRhabdomyosarcomaRelapsed Pediatric Solid TumorRefractory Pediatric Solid TumorMelanomaHepatoblastomaHepatocellular CarcinomaNeuroblastomaWilms Tumor
Interventions
PROCEDURE

Cryoablation Therapy

"Cryoablation therapy is an established method of cancer treatment in adults and pediatrics with certain types of tumors and is standard of care for certain tumors in the setting of progression/relapse.~Percutaneous image-guided Cryoablation (cryosurgery, cryotherapy) is a technique that utilizes successive rapid freeze/thaw cycles to destroy tumor cells. This technique is performed by inserting specialized needles known as cryoprobes into target tumors under imaging guidance with Computed Tomography (CT) and Ultrasound (US), or Magnetic Resonance Imaging (MRI). After the cryoprobe needles are placed within the target tumor, rapid cooling of liquid gas inserted into these probes leads to temperatures reaching -20 to -40 degrees Celsius.~Cryoablation therapy of one disease site will be done starting Day 3 and prior to Day 15 of Cycle 1 only."

DRUG

Nivolumab

"Nivolumab (Bristol Myers Squibb) is a human monoclonal antibody (immunoglobulin G4) that targets the programmed death-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.~Nivolumab and ipilimumab will be given on day 1 of 21-day cycles for cycles 1-4, followed by nivolumab alone on days 1 and 15 of 28-day cycles for cycles 5+. Patients will receive up to 13 cycles of therapy unless unacceptable toxicity or progression of disease."

DRUG

Ipilimumab

"Ipilimumab (Bristol Myers Squibb) is a fully human monoclonal immunoglobulin G1Κ specific for human cytotoxic T-lymphocyte antigen 4 (CTLA-4, cluster of differentiation \[CD\]152), which is expressed on a subset of activated T-cells.~Nivolumab and ipilimumab will be given on day 1 of 21-day cycles for cycles 1-4, followed by nivolumab alone on days 1 and 15 of 28-day cycles for cycles 5+. Patients will receive up to 13 cycles of therapy unless unacceptable toxicity or progression of disease."

Trial Locations (1)

20010

Children's National Hospital, Washington D.C.

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Children's National Research Institute

OTHER