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New cocktail of four drugs aims to tackle childhood cancers that Won't go away

NCT ID NCT05468359

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jun 2037

An estimate. End dates often move.

Lead sponsor

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

Up to 30 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Methodist Le Bonheur Healthcare

    WITHDRAWN

    Germantown, Tennessee, 38138, United States

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

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