New cocktail of four drugs aims to tackle childhood cancers that Won't go away
NCT ID NCT05468359
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a combination of four drugs—atezolizumab, sorafenib, bevacizumab, and cyclophosphamide—in children and young adults with solid tumors that have come back or not responded to standard treatment. The goal is to find safe doses and see if the combination can shrink tumors. The trial has two parts: the first focuses on safety and dosing, and the second looks at how well the treatment works in specific rare cancers like fibrolamellar carcinoma and hepatocellular carcinoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Atezolizumab, sorafenib, bevacizumab, and cyclophosphamide
- What this could lead to
- If successful, this could offer a new treatment option for children with relapsed or hard-to-treat solid tumors, including rare liver cancers.
- What could go wrong
- This is an early-phase trial with a small number of participants. The drug combination may cause serious side effects, and it is not yet known if it will shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Jun 2037
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 30 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age: Patients must be \< 30 years at the time of enrollment on study. * Willingness to enroll on the St. Jude Molecular Analysis of Solid Tumors (MAST) study. * Diagnosis * Part 1: Patients with refractory or recurrent (relapsed) solid tumors accessible by biopsy for which there is no standard therapy are eligible. * Part 2: Patients with one of the following diagnoses: * Biopsy accessible refractory or recurrent (relapsed) hepatocellular carcinoma * Biopsy accessible refractory or recurrent (relapsed)or FL-HCC, DSRCT or non-CNS MRT. * Performance level: Karnofsky \> 50 for patients \> 16 years of age and Lansky \> 50 for patients \< 16 years of age (See Appendix III). Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * Disease status: Patients must tumors that are unresectable and have either measurable or evaluable disease that is accessible by biopsy * Organ function: Must have adequate organ and bone marrow function as defined by the following parameters: * Patients with solid tumor not metastatic to bone marrow: * Peripheral absolute neutrophil count (ANC) \>1,000/mm3 * Platelet count \> 75,000/mm3 (no transfusion within 7 days of enrollment) * Hemoglobin \> 8 g/dL (with or without support) * Patients with solid tumor metastatic to bone marrow will be eligible for study but not evaluable for hematologic toxicity. These patients must not be known to be refractory to red cell or platelet transfusions. At least 2 of every cohort of 3 patients must be evaluable for hematologic toxicity. If dose limiting hematologic toxicity is observed at any dose level, all subsequent patients enrolled must be evaluable for hematologic toxicity. * Adequate renal function defined as serum creatinine based on age as shown in Table 1, or creatinine clearance or radioisotope GFR 50 ml/min/1.73m2 (GFR 40 ml/min/1.73m2 if \< 2 years of age). * Adequate hepatic function defined as total bilirubin \< 5x upper limit of normal (ULN) and AST/ALT \< 3 x ULN for age. * Adequate cardiac function defined as shortening fraction \> 28% OR ejection fraction of ≥ 47% by echocardiogram. * Adequate blood clotting defined as PT/PTT \< 1.2 x ULN without factor replacement products for 7 days * Females of childbearing potential and males able to father a child must be willing to practice acceptable methods of birth control to prevent pregnancy during the study and for at least 5 months after last dose of therapy. * Patients must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, surgery, or radiotherapy prior to entering this study: * Myelosuppressive chemotherapy: Patient has not received myelosuppressive chemotherapy within 1 weeks of enrollment onto this study (within 2 weeks of estimated therapy start date) (4 weeks if prior nitrosourea). * Hematopoietic growth factors: At least 7 days must have elapsed since the completion of therapy with a growth factor. At least 14 days must have elapsed after receiving pegfilgrastim. * Biologic (anti-neoplastic agent): At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur. * Monoclonal antibodies: At least 14 days (at least 21 days from therapy start date) must have elapsed since the completion of therapy with a monoclonal antibody. * Radiotherapy: At least 1 week (2 weeks from estimated therapy start date) must have elapsed since any irradiation; at least 5 weeks (at least 6 weeks from estimated therapy start date) must have elapsed since craniospinal RT or substantial bone marrow irradiation. * Chemoembolization: at least 21 days (28 days from estimated therapy start date) must have elapsed since the completion of chemoembolization * Radioembolization: at least 21 days (28 days from estimated therapy start date) must have elapsed since the completion of radioembolization * Cardiac disease or hypertension: Patients must not have a history of myocardial - infarction, severe or unstable angina, or severe peripheral vascular disease. Hypertension must be well controlled on stable doses of medication for at least two weeks. * Female participant who is post-monarchal must have a negative urine or serum pregnancy test. * Life expectancy of at least 8 weeks Exclusion Criteria: * Pregnant or breastfeeding. * Currently receiving other investigational drugs. * Unwilling or unable to comply with the safety monitoring requirements of this protocol. * Tumor not safely accessible by biopsy * Inability or unwillingness of research participant or legal guardian / representative to give written informed consent. * Surgical procedures and serious or non-healing wounds: patients with a documented, chronic non-healing wound, ulcer, or bone fracture or history of a major surgical procedure or significant traumatic injury within 28 days prior to beginning therapy are excluded due to preclinical evidence supporting the potential for delayed wound healing. * Minor surgical procedures for minimally invasive biopsies will be allowed. For minor surgeries, the wound must be healed, and 7 days elapsed since surgery. For procedures such as the placement of an indwelling IV catheter, it is recommended that bevacizumab be postponed for at least 24 hours after the procedure. * Thrombosis: Patients must not have a deep venous or arterial thrombosis (including pulmonary embolism) within the last three months prior to study entry and must not have a known thrombophilic condition (i.e., protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Methodist Le Bonheur Healthcare
WITHDRAWNGermantown, Tennessee, 38138, United States
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St. Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
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