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Monthly Update Report for Trials Started in February 2026


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1: Summary data from new trials identified for Pediatric Cancer.


Overview

Number of Trials: 16

These 16 trials span diverse cancer types and interventions, including pediatric and adult populations. Several trials test novel CAR T-cell therapies, immunotherapies, and targeted agents (e.g., LNTH-2403, cabozantinib, cemiplimab, visugromab) in relapsed/refractory solid tumors, leukemias, and CNS malignancies. Others evaluate supportive care interventions such as exercise, virtual reality education, donor lymphocyte infusions, and dietary modifications. Biomarker-driven and genomic trials are present, alongside studies of radiotherapy schedules, stem cell transplantation with novel depletion strategies, and electronic health record tools. The trials emphasize combination therapies, immune modulation, and quality-of-life improvements for patients with advanced or high-risk cancers.

Common Criteria Across Trials

Common Inclusion

  • Histologically or cytologically confirmed diagnosis of malignancy
  • Age criteria specified (ranging from infants to adults up to 75 years)
  • Adequate organ function (renal, hepatic, cardiac, pulmonary)
  • Performance status (ECOG, Karnofsky, or Lansky) above specified threshold
  • Measurable or evaluable disease per RECIST or other criteria
  • Prior systemic therapy allowed or required (varies by trial)
  • Written informed consent or assent obtained
  • Adequate hematologic function (ANC, platelets, hemoglobin)
  • Negative pregnancy test for females of childbearing potential
  • Willingness to use contraception during and after study

Common Exclusion

  • Active uncontrolled infection
  • Pregnant or breastfeeding
  • Known HIV, hepatitis B, or hepatitis C (unless controlled)
  • Active autoimmune disease requiring systemic treatment
  • Concurrent malignancy or recent malignancy within specified timeframe
  • CNS metastases or active CNS disease (unless treated and stable)
  • Significant cardiac dysfunction or recent myocardial infarction
  • Prior organ transplantation
  • Use of systemic corticosteroids above specified dose
  • Uncontrolled hypertension or other cardiovascular risk factors
  • History of severe allergic reactions to study agents
  • Inability to comply with study procedures

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07357519

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, -Radiation Dosimetry, and Preliminary Anti-Neoplastic Activity of LNTH-2403, a LRRC15-targeted 177Lutetium-labeled Monoclonal Antibody, in Participants With Relapsed / Refractory Osteosarcoma

Organization/Sponsor: Lantheus Medical Imaging


Example patient: A 15-year-old patient with relapsed osteosarcoma after neoadjuvant chemotherapy, ECOG PS 1, weighing 45 kg, with measurable lung metastases and no active infections.

Phase 1, Phase 2

Interventions

  • Radiopharmaceutical: LNTH-2403
    Summary: LNTH-2403 is a 177Lutetium-labeled monoclonal antibody targeting LRRC15, designed to deliver targeted radiotherapy to osteosarcoma tumors. Phase 1 evaluates dose escalation for safety and tolerability, while Phase 2 assesses the recommended phase 2 dose for anti-neoplastic activity. Source: Summary of Web Search and trial title.

Key Inclusion

  • Histopathologic documented diagnosis of relapsed/refractory osteosarcoma
  • Age ≥12 years for Phase 2 and subsequent Phase 1 cohorts; ≥18 years for first Phase 1 cohort
  • ECOG Performance Score 0-2 or Lansky PS ≥50
  • Body weight ≥30 kg
  • Progression following at least one course of chemotherapy including neoadjuvant/perioperative therapy
  • Measurable disease per RECIST 1.1 or evaluable non-measurable disease or 18F-FDG-PET avid bone-only disease
  • Prior therapy adverse events resolved to Grade 1 or baseline
  • Negative serum pregnancy test for women of childbearing potential

Key Exclusion

  • Known allergies or hypersensitivity to LNTH-2403 or excipients
  • Concurrent treatment with other anti-neoplastic agents including localized radiation therapy
  • Known active infection
  • Participation in another interventional investigational agent study
  • Active prior or concurrent malignancy
  • Known active liver disease or Hepatitis A Virus
  • HIV positive status
  • Major surgical procedure within 28 days of first dose

NCT07254793

A Feasibility/Pilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation

Organization/Sponsor: University of Arizona


Example patient: A 28-year-old male with relapsed acute myeloid leukemia post-matched sibling donor transplant, Karnofsky score 80%, no active GvHD, with a healthy 32-year-old sibling donor able to perform exercise testing.

Phase N/A

Interventions

  • Biological: Standard Therapeutic DLI
    Summary: Standard donor lymphocyte infusion uses donor T-cells to treat leukemia or lymphoma relapse post-transplant by leveraging graft-versus-tumor effect, though it can cause graft-versus-host disease (Summary of Web Search).
  • Biological: Exercise Mobilized Therapeutic DLI
    Summary: Exercise-enhanced donor lymphocyte infusion mobilizes NK-cells and T-cells with higher anti-tumor activity to fight leukemia and lymphoma post-transplantation (Summary of Web Search).
  • Biological: Standard Prophylactic DLI
    Summary: Prophylactic donor lymphocyte infusion prevents leukemia or lymphoma relapse post-transplant by stimulating graft-versus-tumor effect to destroy residual malignant cells in high-risk patients (Summary of Web Search).
  • Biological: Exercise Mobilized Prophylactic DLI
    Summary: Exercise-enhanced prophylactic donor lymphocyte infusion improves immune response against leukemia relapse post-HCT by mobilizing donor lymphocytes with enhanced anti-tumor activity (Summary of Web Search).

Key Inclusion

  • Aged 0-65 years
  • Diagnosis of acute leukemia, MDS, CML, or NHL
  • Undergoing myeloablative or reduced intensity matched sibling or haploidentical HCT
  • Locally available healthy matched or haploidentical related donor aged 12-50 years
  • Donor able to complete fitness evaluation for VO2max and peak cycling power
  • Donor weight greater than 30 kg
  • Donor cardiac, renal, pulmonary, hepatic function within normal limits
  • Donor CBC and CMP within normal limits

Key Exclusion

  • Acute grade III-IV aGvHD or moderate/severe chronic GvHD
  • Requiring immunosuppression therapy for GvHD treatment
  • AST/ALT greater than 5x ULN or bilirubin greater than 2x ULN
  • Creatinine greater than 2x ULN or GFR less than 40 ml/min/1.73m2
  • DLCO less than 40% or O2 Sat less than 92%
  • Left ventricular ejection fraction less than 35%
  • Uncontrolled or severe bacterial, fungal, or viral infection
  • Positive pregnancy test for post-menarche girls or women of childbearing age

NCT06507748

A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1) Genomic-based

Organization/Sponsor: National Institutes of Health Clinical Center (CC)


Example patient: A 7-year-old Spanish-speaking child with genetically confirmed NF1, normal pupillary reflexes, no chronic eye medications, and a caregiver available to assist with device fitting and pain assessments.

Phase N/A

Interventions

  • Device: AlgometRx Nociometer
    Summary: Non-invasive pupillometry device that measures acute pain by assessing pupillary response, used to monitor pain levels in pediatric cancer patients during clinical trials and postoperative follow-up (Web Search).

Key Inclusion

  • Clinical or genetic diagnosis of NF1 per 2021 revised diagnostic criteria
  • Age >= 1 year
  • At least one digit without open wounds for device application
  • Individuals must understand English or Spanish
  • Caregiver willing to assist children <18 years with study procedures
  • Ability to provide informed consent

Key Exclusion

  • History of eye pathology precluding pupillometry
  • Problems with pupillary reflex, blindness, or inability to open one eye fully
  • Chronic use of medication affecting pupillary response (e.g., atropine eye drops)
  • Uncontrolled intercurrent illness that would increase participant risk

NCT07147179

Pilot Trial of Short Course Radiotherapy for Primary or Secondary CNS Malignancies

Organization/Sponsor: Abramson Cancer Center at Penn Medicine


Example patient: A 14-year-old with Lansky score 50 and recurrent medulloblastoma with multiple brain metastases requiring palliative radiation after prior treatment failure.

Phase N/A

Interventions

  • Radiation: Short Course Radiotherapy
    Summary: Condensed radiation treatment delivering high-dose radiation in fewer sessions to target intracranial tumors, minimizing side effects and enabling quick intervention for aggressive pediatric cancers (Source: Web Search Summary).

Key Inclusion

  • Age 21 years or below
  • Lansky performance status >= 40
  • Incurable malignancy metastatic to brain or recurrent within brain
  • At least 1 targetable intracranial lesion on imaging
  • Multidisciplinary consensus for palliative intent radiation
  • Prior radiation in planned treatment area allowed

Key Exclusion

  • Radiotherapy for curative intent
  • Serious uncontrolled systemic or psychiatric disorders
  • Planned for proton radiation

NCT06654466

Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing Genomic-based

Organization/Sponsor: Nest Genomics


Example patient: A 32-year-old English-speaking woman receiving care at Dana Farber with a BRCA1 pathogenic variant identified on prior testing, currently cancer-free and not undergoing active treatment.

Phase N/A

Interventions

  • Software Platform: Nest
    Summary: EMR-integrated platform using AI to streamline genomic data management and deliver longitudinal genetics-based care for cancer patients with pathogenic variants. Source: Web Search.

Key Inclusion

  • Ages 18-49 years
  • Pathogenic or likely pathogenic variant from prior cancer genetic testing
  • Increased cancer risk warranting clinical management
  • English-speaking and reading
  • Receiving care at Dana Farber Cancer Institute
  • Not in active cancer therapy at time of approach

Key Exclusion

  • Age less than 18 or greater than 49 years
  • No prior genetic testing for hereditary cancer syndromes
  • No pathogenic or likely pathogenic variant identified
  • Non-English speaking and reading
  • Not receiving care at Dana Farber Cancer Institute
  • Active cancer with therapy in progress

NCT07374692

Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors Genomic-based

Organization/Sponsor: National Institutes of Health Clinical Center (CC)


Example patient: A 17-year-old with recurrent IDH-wild-type glioblastoma scheduled for tumor resection at NIH, 8 months post-radiation therapy, undergoing tissue collection for genetic profiling.

Phase N/A

Interventions

  • Procedure: Tumor sample collection
    Summary: Tumor sample collection targets adaptable tumors evading single-target therapies by identifying actionable genetic alterations to improve treatment outcomes in pediatric cancer trials (Web Search).

Key Inclusion

  • Advanced CNS tumors confirmed by documented pathology report
  • Recurrent IDH-wild-type high-grade glioma
  • Recurrent IDH-mutant gliomas
  • Other recurrent CNS tumors
  • Scheduled for brain tumor biopsy or resection
  • At least 6 months after any previous radiation therapy if applicable
  • Age 15 years or older
  • Procedures planned at NIH

Key Exclusion

  • None specified

NCT06345027

Chimeric Antigen Receptor Treatment Targeting CD70 (SEVENTY) Genomic-based

Organization/Sponsor: Baylor College of Medicine


Example patient: A 42-year-old adult with relapsed AML expressing 35% CD70+ blasts after failing two cycles of induction chemotherapy and FLT3 inhibitor therapy, with an identified matched sibling donor for future transplant and Karnofsky score of 70%.

Phase N/A

Interventions

  • Biological: CD70-targeted CAR T-cell therapy
    Summary: Chimeric antigen receptor T-cell therapy targeting CD70 antigen on leukemia cells, designed to treat relapsed or refractory CD70-positive hematological malignancies as a bridge to allogeneic transplant (source: trial design).

Key Inclusion

  • Primary refractory or relapsed AML (except APL) or other CD70+ leukemia
  • CD70 positive leukemia with at least 26% CD70+ cells
  • Age ≤75 years; first 3 patients must be adults ≥18 years
  • Failed or ineligible for targeted therapies (FLT3, IDH, anti-CD33) if applicable
  • CD19+ leukemia patients must have failed or be ineligible for commercial CD19 CAR-T
  • Suitable allogeneic HSCT donor identified or patient declines HSCT
  • Karnofsky/Lansky score ≥60%
  • No systemic chemotherapy 2 weeks prior to treatment

Key Exclusion

  • Acute promyelocytic leukemia (APL)
  • Uncontrolled active infection requiring ongoing therapy without improvement
  • CNS disease with detectable cerebrospinal blast cells
  • Acute GVHD ≥Grade 2 or moderate to severe chronic GVHD
  • High dose steroids >0.5 mg/kg/day prednisone equivalent
  • Cardiac dysfunction NYHA III/IV or LVEF <50%
  • Hyperleukocytosis (WBC ≥50K) or rapidly progressive disease
  • Pregnant or lactating

NCT06900595

A Phase II Study of Cabozantinib in Combination With Cemiplimab (Cabo-Cemiplimab) Versus Cabozantinib Alone in Adolescents and Adults With Advanced Adrenocortical Cancer

Organization/Sponsor: National Cancer Institute (NCI)


Example patient: A 16-year-old with metastatic adrenocortical carcinoma and corticosteroid-producing tumor who received one prior line of EDP-M chemotherapy, has ECOG performance status 1, and adequate organ function without prior immunotherapy exposure.

Phase II

Interventions

  • Drug: Cabozantinib
    Summary: Cabozantinib is an orally bioavailable multi-targeted tyrosine kinase inhibitor that targets c-MET, VEGFR 1-3, RET, AXL, KIT, FLT-3, TIE-2, and TRKB to inhibit tumor growth and angiogenesis. FDA approved for metastatic medullary thyroid cancer and studied in pediatric solid tumors. Source: FDA label, NCI Thesaurus.
  • Biological: Cemiplimab
    Summary: Cemiplimab is a human monoclonal antibody PD-1 checkpoint inhibitor that blocks PD-1 interaction with PD-L1/PD-L2, restoring T-cell immune function against tumors. FDA approved for cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer. Source: FDA label, NCI Thesaurus.
  • Procedure: Biospecimen Collection
    Summary: Collection of tissue and fluid samples for research to analyze genetic and molecular features, understand cancer mechanisms, and develop targeted therapies. Source: NCI Thesaurus.
  • Procedure: Computed Tomography
    Summary: Imaging method using X-rays and computer reconstruction to create cross-sectional scans for detecting cancer spread and monitoring tumor progression. Source: NCI Thesaurus.
  • Procedure: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed internal organ pictures for cancer diagnosis and monitoring. Source: NCI Thesaurus.

Key Inclusion

  • Histologically or cytologically confirmed adrenocortical carcinoma
  • Locally advanced unresectable or recurrent/metastatic disease
  • Age 12 years and above with BSA ≥1.2 m²
  • Up to 3 prior lines of systemic therapy allowed
  • No prior cMET inhibitors, anti-CTLA-4, or anti-PD-1/PD-L1 therapy
  • ECOG performance 0-2 or Lansky/Karnofsky ≥50
  • ANC ≥1,000/mcL, platelets ≥100,000/mcL, hemoglobin ≥8 g/dL
  • Adequate hepatic and renal function

Key Exclusion

  • Prior treatment with cabozantinib or cMET inhibitors
  • Prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy
  • Active autoimmune disease requiring systemic immunosuppression
  • Uncontrolled hypertension (SBP ≥150 or DBP ≥90 mmHg)
  • GI perforation, active bleeding, or inflammatory bowel disease within 6 months
  • Brain metastases unless stable for ≥4 weeks without corticosteroids
  • Major surgery within 2 weeks or minor surgery within 10 days
  • Steroid use >10 mg prednisone equivalents daily

NCT07224204

Life at 100.4: An Immersive Social Virtual Reality Education Tool for Adolescent and Young Adult Cancer Patients and Caregivers

Organization/Sponsor: Yale University


Example patient: A 16-year-old adolescent newly diagnosed with acute lymphoblastic leukemia scheduled to begin chemotherapy with central line placement and no history of seizures or head trauma.

Phase N/A

Interventions

  • Behavioral: Life at 100.4
    Summary: An immersive virtual reality education tool designed to support pediatric cancer patients and caregivers through the treatment journey, providing educational content about chemotherapy and cancer care (Source: Web Search).

Key Inclusion

  • Newly diagnosed with a malignancy or bone marrow failure condition
  • Planned to receive chemotherapy
  • Planned to receive a central line

Key Exclusion

  • Medical contraindication to virtual reality
  • Head wounds
  • History of seizure with flashing lights
  • No plan to receive chemotherapy

NCT07365007

Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors

Organization/Sponsor: University of Michigan Rogel Cancer Center


Example patient: A 52-year-old English-speaking breast cancer survivor with moderate tingling in hands and feet six months post-chemotherapy, consuming occasional sweets, with internet access and no pre-existing neuropathy.

Phase N/A

Interventions

  • Behavioral: Survey Administration
    Summary: Self-reported data collection tool to assess patient experiences, symptoms, and knowledge in clinical trials (NCI Thesaurus, Web Search).
  • Behavioral: Interview
    Summary: Qualitative method gathering patient-reported outcomes and personal details regarding treatment experiences and preferences (NCI Thesaurus, Web Search).
  • Other: Electronic Health Record Review
    Summary: Analysis of patient data from electronic records to assess outcomes and inform personalized care (NCI Thesaurus, Web Search).
  • Behavioral: Educational Intervention
    Summary: Educational activity using lectures, brochures, and multimedia to prevent disease or alter disease course through knowledge improvement (NCI Thesaurus, Web Search).
  • Other: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for genetic and molecular analysis to understand cancer mechanisms and develop targeted therapies (NCI Thesaurus, Web Search).

Key Inclusion

  • 18 years or older
  • At least three months since last neurotoxic chemotherapy
  • Moderate numbness and tingling (≥2/4 severity) in last week
  • Speak and read English
  • Have internet access
  • Consuming less than 5 servings per week of sweets or sugar-sweetened beverages

Key Exclusion

  • Pre-existing neuropathy from any cause
  • Plan to begin duloxetine during study period
  • Enrolled in other symptom management trials
  • Current inflammatory disease
  • Routine NSAID or steroid supplementation
  • Consuming 3+ servings of fish per week or fish oil/flax oil capsules daily

NCT07194044

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes Genomic-based

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 14-year-old male with newly diagnosed widely metastatic Ewing sarcoma involving bone and liver, who has received one cycle of VDC chemotherapy and has adequate organ function with tissue available for correlative testing.

Phase N/A

Interventions

  • Drug: Liposomal doxorubicin
    Summary: Liposomal doxorubicin interferes with DNA replication in cancer cells and is used to treat various cancers including refractory pediatric solid tumors (Summary of Web Search).
  • Drug: Etoposide
    Summary: Etoposide targets DNA topoisomerase II and is effective against various pediatric tumors including rhabdomyosarcoma (Summary of Web Search).
  • Drug: Temozolomide
    Summary: Temozolomide is an alkylating agent that methylates DNA at O6 and N7 positions of guanine, inhibiting DNA replication; indicated for glioblastoma and anaplastic astrocytoma (FDA label, NCI Thesaurus).
  • Drug: Topotecan
    Summary: Topotecan inhibits topoisomerase I by stabilizing topoisomerase I-DNA complexes, producing DNA breaks during replication; indicated for small cell lung cancer and cervical carcinoma (FDA label, NCI Thesaurus).
  • Drug: Cabozantinib
    Summary: Cabozantinib is a multi-targeted tyrosine kinase inhibitor targeting MET, VEGFR, RET, AXL, and other RTKs, inhibiting tumor growth and angiogenesis; indicated for medullary thyroid cancer (FDA label, NCI Thesaurus).
  • Drug: Irinotecan
    Summary: Irinotecan is a topoisomerase I inhibitor prodrug converted to SN-38, which stabilizes the cleavable complex between topoisomerase I and DNA, causing DNA breaks; indicated for metastatic colorectal cancer (FDA label, NCI Thesaurus).
  • Drug: Actinomycin
    Summary: Actinomycin (dactinomycin) is an antibiotic that inhibits DNA transcription, targeting rapidly dividing cancer cells; used in Wilms tumor and rhabdomyosarcoma (Summary of Web Search).
  • Drug: Ifosfamide
    Summary: Ifosfamide is an alkylating chemotherapy agent that interferes with DNA, inhibiting cancer cell replication; used in pediatric refractory solid tumors (Summary of Web Search).
  • Drug: Cyclophosphamide
    Summary: Cyclophosphamide is an alkylating agent that cross-links DNA, disrupting cancer cell replication; indicated for lymphomas, leukemias, breast cancer, ovarian cancer, and pediatric nephrotic syndrome (FDA label, NCI Thesaurus).
  • Drug: Doxorubicin
    Summary: Doxorubicin is an anthracycline that intercalates DNA and inhibits topoisomerase II, preventing DNA replication and generating free radicals; indicated for breast cancer, leukemias, lymphomas, and solid tumors (FDA label, NCI Thesaurus).
  • Drug: Vincristine
    Summary: Vincristine is a vinca alkaloid that disrupts microtubule formation, arresting tumor cells in metaphase; indicated for acute leukemia, lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor (FDA label, NCI Thesaurus).

Key Inclusion

  • Patients must be >1 year of age with no upper age limit
  • New histologic diagnosis of widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma
  • Sufficient tissue submitted for correlative testing (flash frozen, FFPE block, or unstained slides)
  • May have started initial cycle of VDC prior to enrollment but not ifosfamide/etoposide
  • Adequate organ function
  • Healthy enough to tolerate protocol therapy
  • Use of two methods of contraception or abstinence for reproductive-age patients
  • Ability to understand and sign informed consent or assent

Key Exclusion

  • Localized disease or lung-only metastases for Ewing sarcoma
  • Localized disease for CIC-rearranged sarcomas
  • Central nervous system tumors (primary or metastatic)
  • Receiving other investigational agents for cancer
  • History of cancer treated with myelosuppressive chemotherapy or radiation
  • Receiving additional medicines for treating cancer
  • Uncontrolled intercurrent illness
  • Pregnancy or breastfeeding

NCT07219459

A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in Combination With Nivolumab and a Tyrosine Kinase Inhibitor Compared to Double Placebo and a Tyrosine Kinase Inhibitor in Participants With Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Anti PD-(L)1 Compound (GDFATHER HCC-01)

Organization/Sponsor: CatalYm GmbH


Example patient: A 62-year-old with Child-Pugh A metastatic hepatocellular carcinoma, ECOG 1, who progressed after 16 weeks of first-line nivolumab-based therapy and has no history of transplantation or autoimmune disease.

Phase 2

Interventions

  • Drug: Placebo Saline Infusion
    Summary: Sodium Chloride 0.9% sterile solution for intravenous fluid and electrolyte replenishment, used as placebo control in this trial (FDA label).
  • Drug: Tyrosine kinase inhibitor (TKI)
    Summary: Enzyme inhibitor targeting tyrosine kinase to block signal transduction pathways involved in cell proliferation and growth (NCI Thesaurus).
  • Biological: Nivolumab
    Summary: Fully human IgG4 monoclonal antibody blocking PD-1 receptor to enhance T-cell activation and immune response against tumors (FDA label, NCI Thesaurus).
  • Biological: Visugromab RDE
    Summary: Humanized IgG4 monoclonal antibody targeting GDF-15 to restore immune cell infiltration and overcome tumor immunosuppression (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed unresectable or metastatic HCC
  • Measurable disease per RECIST v1.1
  • Failed one prior systemic treatment containing anti-PD(L)-1 checkpoint inhibitor
  • Minimum 12 weeks exposure to checkpoint inhibitor without progression
  • Age ≥18 years
  • Life expectancy ≥3 months
  • ECOG performance status ≤1
  • Child-Pugh score A6 or better

Key Exclusion

  • Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma
  • More than 1 prior systemic treatment line
  • Palliative radiotherapy within 28 days
  • Active CNS involvement by HCC
  • Myocardial infarction or stroke within 3 months
  • Active autoimmune disease requiring systemic treatment in past 3 months
  • Metformin use in type II diabetes patients
  • Prior liver or organ transplantation

NCT07278778

A Pilot Study of Cancer Care Companion, An Electronic Health Record Tool to Improve Information Exchange and Self-Management in Pediatric Cancer

Organization/Sponsor: Washington University School of Medicine


Example patient: A 6-year-old child diagnosed with acute lymphoblastic leukemia two weeks ago, beginning chemotherapy at St. Louis Children's Hospital, whose English-speaking parent has internet access and enrolls in Epic MyChart.

Phase N/A

Interventions

  • Digital Health Tool: Cancer Care Companion
    Summary: An EHR-based tool that facilitates communication between parents and healthcare providers to improve information exchange and self-management in pediatric cancer care (Source: Web Search).

Key Inclusion

  • Legal guardian of child diagnosed with cancer in prior 4 weeks
  • Child plans to receive or currently receives cancer directed therapy at St. Louis Children's Hospital
  • Parent has access to internet through computer or smart phone
  • Speaks and reads in English
  • Parent agrees to enroll in Epic MyChart to access proxy portal for child

Key Exclusion

  • None

NCT06625190

Allogeneic Stem Cell Transplantation Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory Solid Tumors

Organization/Sponsor: University of Florida


Example patient: A 14-year-old with relapsed high-risk neuroblastoma after failed autologous transplant, Karnofsky score 70%, adequate organ function, and an available haplo-identical sibling donor.

Phase N/A

Interventions

  • Drug: Zoledronic acid
    Summary: Zoledronic acid inhibits bone resorption by targeting osteoclasts, used to treat bone metastases in pediatric cancer, particularly osteosarcoma, and helps strengthen bones and manage pain (Summary of Web Search).
  • Device: Miltenyi CliniMACS Prodigy® system
    Summary: The Miltenyi CliniMACS Prodigy® system automates production of GMP-compliant cell therapies, performing alpha/beta T cell and CD19+ B cell depletion for allogeneic transplantation in pediatric oncology (Summary of Web Search).

Key Inclusion

  • Age 6 months to ≤25 years
  • Relapsed/refractory solid tumors including neuroblastoma, rhabdomyosarcoma, NRSTS, osteosarcoma, Ewing sarcoma
  • Failed or ineligible for autologous transplant or <20% cure chance
  • Haplo-identical related donor with at least one full haplotype match
  • Karnofsky or Lansky score ≥60%
  • Adequate organ function: pulmonary FEV1/FVC/DLCO ≥50%, creatinine clearance ≥60 mL/min/1.73 m2, ejection fraction ≥40%
  • Contraception required for individuals of childbearing potential

Key Exclusion

  • Documented uncontrolled infection at study entry
  • Allogeneic HSCT within 6 months
  • No eligible allogeneic donor available
  • Life expectancy <3 months
  • Inadequate organ function
  • Pregnant or breastfeeding females
  • Unwilling to use contraception for one year post-transplant
  • Prisoners or involuntarily incarcerated subjects

NCT07359911

Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patients (ACTIVE-SARC)

Organization/Sponsor: University of Miami


Example patient: A 17-year-old Spanish-speaking adolescent with newly diagnosed osteosarcoma starting doxorubicin-based chemotherapy, sedentary lifestyle, able to walk independently, and stable disease without bone metastases.

Phase N/A

Interventions

  • Behavioral: Exercise Intervention
    Summary: A managed physical activity program designed to improve health and wellbeing; modulates tumor microenvironment, reduces tumor growth via p53 activation and autophagy, and targets cancer-related fatigue to improve quality of life (NCI Thesaurus, Web Search).
  • Other: Usual Care Control
    Summary: A comparator treatment in a clinical trial against which the treatment under study is evaluated (NCI Thesaurus).
  • Other: Exit Interview
    Summary: Assesses caregiver experiences and patient outcomes post-treatment, focusing on disease impact and symptom changes to improve care transitions for survivors (Web Search).

Key Inclusion

  • Diagnosis of Sarcoma
  • Pediatric or AYA (12-39 years old)
  • Initiating first-line systemic therapy within 90 days
  • Able to speak, read, and understand English or Spanish
  • Not consistently engaged in more than 90 minutes moderate or 45 minutes vigorous physical activity per week over past 3 months
  • Not consistently engaged in resistance training 2 or more days per week over past 3 months
  • Approval from medical oncology provider to participate

Key Exclusion

  • Less than 12 or greater than 39 years old
  • Oxygen-dependent
  • Unable to walk 2 blocks without assistance (excluding canes)
  • Unstable bone metastases
  • More than 90 days from initiation of first-line systemic therapy
  • Severe medical condition or psychiatric condition precluding participation
  • Unable to provide consent

NCT07428993

A Phase II Study Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma

Organization/Sponsor: St. Jude Children's Research Hospital


Example patient: A 14-year-old with newly diagnosed high-risk osteosarcoma who completed MAP consolidation chemotherapy 3 weeks ago, has stable disease, adequate organ function with ANC 900 cells/uL, and Lansky score of 70.

Phase II

Interventions

  • Biological: SJCARB7H3_41BBL infusion
    Summary: B7-H3-specific CAR T-cell therapy using genetically engineered T cells to target B7-H3 on tumor cells for treating pediatric solid tumors including osteosarcoma (Web Search).
  • Procedure: Apheresis
    Summary: Medical procedure to collect specific blood components, including T cells for CAR T-cell manufacturing in pediatric cancer treatments (Web Search).
  • Drug: Mesna
    Summary: Uroprotective agent that prevents hemorrhagic cystitis in patients receiving cyclophosphamide by protecting the bladder without affecting anti-cancer activity (Web Search).
  • Drug: Fludarabine
    Summary: Fluorinated nucleoside analog that inhibits DNA synthesis via DNA polymerase and ribonucleotide reductase inhibition, used for lymphodepletion prior to CAR T-cell infusion (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent that cross-links DNA to disrupt cancer cell replication, used for lymphodepletion conditioning and treating various malignancies including solid tumors (FDA label, NCI Thesaurus).

Key Inclusion

  • Newly diagnosed high-risk osteosarcoma
  • Completed consolidation therapy 14-28 days prior (Regimen A) or at least 14 days prior with optional pulmonary metastasectomy (Regimen B)
  • No evidence of progressive disease
  • Lansky performance status ≥50 (<16 years) or Karnofsky ≥50 (≥16 years)
  • Adequate organ function: creatinine ≤1.5x ULN, bilirubin ≤3x ULN, cardiac shortening fraction ≥28%, oxygen saturation ≥90%
  • ANC ≥750 cells/uL, platelets ≥75,000, hemoglobin ≥7 g/dL
  • At least 7 days from supra-physiologic corticosteroids
  • Signed informed consent

Key Exclusion

  • Major surgical adverse event (Clavien-Dindo category 3) requiring ongoing wound care
  • Clinically significant encephalopathy or new focal neurologic deficits
  • Active severe infection (positive blood culture within 48 hours or fever >38.2°C with clinical signs)
  • Prior disease-directed therapy beyond first-line methotrexate, anthracycline, platinum, and local control surgery
  • Pregnant or breastfeeding
  • Any condition prohibiting protocol treatment per investigator judgment