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Study of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab for Pediatric Solid Tumors

This study is testing a combination of four medicines for children and young adults (up to 30 years old) with solid tumors that have come back or are hard to treat. The medicines are atezolizumab, sorafenib, bevacizumab, and cyclophosphamide. Researchers want to see how safe this combination is and how well it works to shrink tumors. They will also look at specific markers in the tumors, like PD-L1, and how the body handles sorafenib. The study is open to patients with certain solid tumors, including hepatocellular carcinoma (a type of liver cancer) and other rare solid tumors, who are willing to have a biopsy.

Study design
This is a Phase I/II study planning to enroll 64 participants. It is an interventional study, meaning participants will receive specific treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures how well the treatment works and the safety of the drugs at the end of cycle 2 (each cycle is 21 days). Sorafenib levels are measured at the end of cycle 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05468359

Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients

Recruiting
PHASE1Up to 30InterventionalTreatment
St. Jude Children's Research Hospital
~64 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:AtezolizumabSorafenibBevacizumabCyclophosphamide

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Recommended phase 2 doses (RP2Ds)
Measured over At the end of cycle 2 (each cycle is 21 days)]
+4 more outcomes measured

Conditions

Refractory Solid Tumor
Hepatocellular Carcinoma
Malignant Solid Tumor
Pediatric Cancer
Pediatric Solid Tumor
Fibrolamellar Carcinoma

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Desmoplastic Small Round Cell TumorFibrolamellar CarcinomaHepatocellular CarcinomaRhabdoid TumorSolid Neoplasm

Where it's being run

2 sites across 1 states
Tennessee2

Study leadership

  • Jessica Gartrell, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Jessica Gartrell, MD
[email protected]
888-226-4343
Email the study team

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Part 1: Recommended phase 2 doses (RP2Ds)At the end of cycle 2 (each cycle is 21 days)]

    The number of participants who develop a dose limiting toxicity within the first two cycles of therapy that are at least possibly, probably or definitely attributable to atezolizumab, bevacizumab, sorafenib or cyclophosphamide.

  • PK measures of SorafenibAt the end of cycle 1 (each cycle is 21 days)]

    The number of participants exhibiting a sorafenib exposure (steady-state AUC0-12h) between 20 and 55 hr·µg/mL by Day 21 of cycle 1.

  • Part 2: Response rateAt the end of cycle 2 (each cycle is 21 days)]

    The number of participants with relapsed or refractory HCC whose tumors show a response (CR+PR) after 2 cycles of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab

  • PK measure of sorafenibAt the end of cycle 1 (each cycle is 21 days)]

    The number of participants who have a sorafenib systemic exposure between 20 and 55 who experience sorafenib-induced skin toxicity compared to the number of participants who have a systemic sorafenib exposure outside of the 20-55 range who experience sorafenib-induced skin toxicity.

  • Parts 1 & 2: Intratumoral T-cell infiltration of CD8+C45RO+ cellsAt the end of cycle 2 (each cycle is 21 days)]

    The number of participants whose tumors show an increase in the ratio of CD45RO+/CD3+ T cells of at least 27% OR who show an absolute increase in CD3+ cells from baseline to the end of cycle 2 (approximately 42 days from the start of therapy).