Sophic Logo gordian knotPediatric Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in March 2026


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


Overview

Number of Trials: 19

These 19 trials span diverse oncology and non-oncology conditions, including pediatric and adult cancers (osteosarcoma, medulloblastoma, glioma, soft tissue sarcoma, multiple myeloma, bladder cancer, leukemia), Cushing's disease, pilonidal disease, pediatric trauma, and common warts. Interventions range from standard chemotherapy and radiation to novel agents (belzutifan, elranatamab, ADI-PEG 20, liothyronine), immunotherapies (atezolizumab, nivolumab), and supportive care (exercise, nutrition, behavioral health). Several trials focus on imaging (FDG-PET, MRI), surgical techniques (LITT, uteroovarian transposition), and digital health tools (apps, telemonitoring). Pediatric trials emphasize family-centered care, adherence, and survivorship. Many trials incorporate biospecimen collection and genomic profiling.

Common Criteria Across Trials

Common Inclusion

  • Age-specific criteria (pediatric, adolescent, young adult, or adult)
  • Histologically confirmed diagnosis or biochemical evidence of disease
  • Adequate organ function (hematologic, renal, hepatic, cardiac)
  • Performance status (Karnofsky ≥50, Lansky ≥50, or ECOG ≤2)
  • Ability to provide informed consent or assent
  • English-speaking or ability to understand study instructions
  • Willingness to use contraception if of childbearing potential
  • Enrollment on companion biospecimen or registry protocols

Common Exclusion

  • Pregnancy or breastfeeding
  • Uncontrolled intercurrent illness or active infection
  • Severe cardiac, renal, hepatic, or pulmonary disease
  • History of allergic reactions to study agents
  • Concurrent investigational agents or other cancer therapies
  • Severe cognitive impairment or psychiatric illness limiting compliance
  • HIV or active hepatitis (in some trials)
  • Prior treatment within specified washout periods
  • Metastatic or unresectable disease (in curative-intent trials)

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


NCT04569591

Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease

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


Example patient: A 12-year-old with biochemically confirmed Cushing's disease, negative pituitary MRI, normal liver and kidney function, controlled blood pressure, and no history of cardiac disease or hyponatremia, scheduled for transsphenoidal surgery.

Phase N/A

Interventions

  • Drug: Desmopressin acetate
    Summary: Synthetic vasopressin analog acting on vasopressin receptors to stimulate ACTH-producing pituitary adenomas for enhanced FDG-PET detection in Cushing's disease (Source: Web Search).

Key Inclusion

  • Age 8 or older with biochemical evidence of Cushing's disease
  • Clinical MRI pituitary result negative or possible adenoma
  • MRI of pituitary with and without contrast within 9 months
  • IPSS required for newly diagnosed cases
  • Surgical candidate agreeing to adenoma resection within 24 weeks of PET
  • Normal liver function tests within 14 days
  • Tolerance of previous DDAVP infusion

Key Exclusion

  • Current pregnancy or lactation
  • GFR less than 50 mL/min/1.73 m²
  • Hyponatremia (serum sodium below 135 mmol/L)
  • Significant coronary artery disease, congestive heart failure, or SIADH
  • Uncontrolled hypertension (BP greater than 150/95 mmHg)
  • Current use of vasopressors, NSAIDs, loop diuretics, or carbamazepine
  • History of Type IIB von Willebrand's disease
  • Blood glucose above 200 mg/dL on scan day

NCT07291297

Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic Soft Tissue Sarcoma

Organization/Sponsor: Wake Forest University Health Sciences


Example patient: A 52-year-old with newly diagnosed metastatic high-grade leiomyosarcoma, ECOG PS 1, adequate organ function, about to start first-line doxorubicin-based chemotherapy, not on metformin, and using effective contraception.

Phase N/A

Interventions

  • Drug: Metformin Hydrochloride ER
    Summary: Extended-release biguanide that inhibits mitochondrial complex I and activates AMPK, reducing hepatic glucose production and improving insulin sensitivity. In cancer, it inhibits mTOR signaling, reduces cyclin D1, and suppresses tumor cell proliferation, migration, and invasion via MMP-9 inhibition. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Advanced unresectable or metastatic intermediate/high grade soft tissue sarcoma
  • Age ≥18 years
  • Initiating first line systemic therapy for advanced/metastatic disease (treatment naïve)
  • ECOG performance status 0-2
  • Adequate renal and liver function
  • Ability to ingest oral medications
  • Negative pregnancy test for individuals of childbearing potential
  • Willing to use highly effective contraception

Key Exclusion

  • Already taking metformin at diagnosis of advanced disease
  • Planned enrollment on treatment clinical trial for first line therapy
  • History of acute or chronic metabolic acidosis including diabetic ketoacidosis
  • Additional malignancy within five years (except DCIS, basal/squamous cell skin cancer, in situ cervical/bladder cancer)
  • Allergy to metformin or receiving CYP450 inhibitors/inducers
  • Uncontrolled intercurrent illness or active infection
  • Known brain or active CNS metastases
  • Breastfeeding during study treatment

NCT07405164

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Organization/Sponsor: Merck Sharp & Dohme LLC


Example patient: A 15-year-old with von Hippel-Lindau disease and renal cell carcinoma currently receiving belzutifan in a parent study with stable disease and no active dose interruptions.

Phase 3

Interventions

  • Drug: Everolimus
    Summary: Everolimus inhibits the mTOR pathway to block cell growth and proliferation, used in pediatric cancers like recurrent ependymoma and studied in combination therapies (Summary of Web Search).
  • Drug: Cabozantinib
    Summary: Cabozantinib is a multi-targeted tyrosine kinase inhibitor targeting c-MET, VEGF, RET, AXL, and other RTKs to inhibit tumor growth and angiogenesis, indicated for metastatic medullary thyroid cancer and studied in pediatric renal cell carcinoma (FDA label, NCI Thesaurus).
  • Drug: Lenvatinib
    Summary: Lenvatinib targets multiple receptor tyrosine kinases to inhibit tumor growth and angiogenesis, studied in pediatric solid tumors including high-grade glioma and rhabdomyosarcoma (Summary of Web Search).
  • Biologic: Nivolumab
    Summary: Nivolumab is a PD-1 blocking antibody that enhances T-cell immune responses against tumors by preventing PD-1 activation, indicated for multiple advanced cancers including melanoma and lung cancer (FDA label, NCI Thesaurus).
  • Drug: Palbociclib
    Summary: Palbociclib inhibits CDK4 and CDK6 to block cell cycle progression, showing potential in pediatric cancers with RB1 alterations and studied in solid tumors and lymphomas (Summary of Web Search).
  • Drug: Belzutifan
    Summary: Belzutifan is an HIF-2α inhibitor approved for treating VHL disease-associated tumors and PPGL in patients aged 12 and older, with adverse effects including anemia and fatigue (Summary of Web Search).

Key Inclusion

  • Advanced solid tumors or von Hippel-Lindau-related neoplasms
  • Participating in belzutifan-containing studies
  • On active treatment in a belzutifan parent study

Key Exclusion

  • On-going serious adverse event in parent study unless no longer hospitalized and clinically stable
  • Currently on dose interruption due to adverse event in parent study

NCT07454902

From Kitchen to Clinic: A Family-Centered, Food-As-Medicine Approach Using Medically Tailored Meals and Caregiver Coaching in Pediatric Oncology Care

Organization/Sponsor: Drexel University


Example patient: A 12-year-old English-speaking child diagnosed with leukemia two weeks ago, living with parents, receiving chemotherapy, with no food allergies or feeding tube requirements.

Phase N/A

Interventions

  • Behavioral: Caregiver Coaching
    Summary: One-on-one support, mentoring, and coaching service for caregivers to enhance patient care and family engagement (NCI Thesaurus).
  • Dietary Supplement: Medically Tailored Meals
    Summary: Customized nutrition plans designed for pediatric cancer patients to meet specific dietary needs, support growth and recovery, and manage treatment side effects (Summary of Web Search).

Key Inclusion

  • Receiving cancer treatment for any cancer diagnosis
  • Within the first 3-6 weeks of diagnosis
  • At least 5-21 years of age at enrollment
  • English-speaking
  • Approved by oncologist and RDN
  • Living in same household as designated caregiver for study duration

Key Exclusion

  • Swallowing or digestive diseases/food allergies (e.g. celiacs, lactose intolerance, nut allergy)
  • Specific food preferences that cannot be accommodated by MANNA
  • Receiving nutrition via nasogastric or gastric tube feedings
  • Bone marrow transplant patient

NCT07439484

A Pilot Study of an Individually Tailored, Supervised, Remotely Delivered Exercise Intervention to Improve Physical Function in Survivors of Gastroesophageal Cancer (PRECISE Study)

Organization/Sponsor: Jonsson Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking adult with Stage II gastric adenocarcinoma who completed chemotherapy 8 months ago and has impaired physical function with a SPPB score of 10.

Phase N/A

Interventions

  • Behavioral: Exercise Intervention
    Summary: A managed physical activity program to improve health and wellbeing, targeting cancer-related fatigue and quality of life through mechanisms like tumor microenvironment modulation and p53 activation (NCI Thesaurus, Web Search).
  • Behavioral: Internet-Based Intervention
    Summary: A program using the internet to modify behavior, focusing on health promotion, stress management, physical activity, and mental well-being support (NCI Thesaurus, Web Search).
  • Other: Physical Performance Testing
    Summary: Activities and tests assessing physical fitness and exercise capacity, including walking speed and timed up and go tests to guide treatment decisions (NCI Thesaurus, Web Search).
  • Other: Survey Administration
    Summary: Presenting surveys or questionnaires to obtain patient responses, assessing experiences, knowledge, anxiety, and trial participation willingness through self-reported data (NCI Thesaurus, Web Search).
  • Other: Educational Intervention
    Summary: Educational activities to prevent disease or alter disease course, addressing physical, emotional, and lifestyle changes through lectures, brochures, and multimedia (NCI Thesaurus, Web Search).
  • Other: Electronic Health Record Review
    Summary: Analyzing patient data in electronic health records to improve care, using personalized feedback and support to enhance outcomes and engagement (NCI Thesaurus, Web Search).
  • Other: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for testing and research to analyze genetic and molecular features, aiding in understanding cancer mechanisms and developing targeted therapies (NCI Thesaurus, Web Search).
  • Device: Actigraphy
    Summary: Continuous recording of body movement using a wearable actimetry sensor to measure rest/activity and sleep/wake cycles over days to weeks (NCI Thesaurus).

Key Inclusion

  • Adults ≥ 18 years old
  • Stage I, II, or III esophageal, gastroesophageal junction, or gastric cancer
  • Adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma histology
  • Treated with at least one systemic therapy (chemotherapy or immunotherapy)
  • Within 12 months of completing curative intent treatment
  • Physical function impairment (SPPB score < 12)
  • Ability to understand English
  • Willingness to sign informed consent

Key Exclusion

  • Stage I disease with endoscopic resection or surgery alone without perioperative systemic therapy
  • Stage IV or unresectable locally advanced disease on palliative treatment
  • Currently receiving ongoing systemic therapy for gastroesophageal cancer or another malignancy
  • Unable to provide informed consent
  • Condition or comorbidity contraindicating participation due to safety concerns
  • Participating in another exercise intervention study targeting functional status or frailty

NCT07389278

A Phase 1/2 Study of Pegylated Arginine Deiminase (ADI-PEG 20) Plus Radiotherapy (RT) and Temozolomide (TMZ) in Children, Adolescents, and Young Adults With Newly Diagnosed High-grade Glioma (HGG) Genomic-based

Organization/Sponsor: University of California, San Francisco


Example patient: A 12-year-old with newly diagnosed H3K27-altered thalamic diffuse midline glioma status post subtotal resection, Lansky score 60, on stable dexamethasone, with adequate organ function and no prior chemotherapy or radiation.

Phase 1, Phase 2

Interventions

  • Radiation: Standard of Care Radiation Therapy (RT)
    Summary: Radiation therapy treats disease by exposing the target or whole body to radiation, often used as curative therapy and occasionally for palliative treatment in cancer (NCI Thesaurus).
  • Drug: Temozolomide (TMZ)
    Summary: Temozolomide is an oral alkylating agent that methylates DNA at O6 and N7 positions of guanine, inhibiting DNA replication and causing cell death in gliomas; it penetrates the CNS well (FDA label, NCI Thesaurus).
  • Biological: ADI-PEG 20 (Arginine deiminase pegylated)
    Summary: Pegargiminase is a PEGylated arginine-degrading enzyme that converts arginine to citrulline, depleting arginine and inhibiting proliferation in arginine-auxotrophic cancer cells; PEGylation enhances half-life (NCI Thesaurus).

Key Inclusion

  • Histologically and molecularly confirmed newly diagnosed WHO grade 3 or 4 glioma
  • Phase 2 cohorts include histone-wildtype HGG, H3K27 altered DMG, and H3G34 mutant DHG
  • Must have undergone maximal safe resection (biopsy sufficient for pontine DMG)
  • No prior therapy except surgery before enrollment
  • Age 3 to <18 years (Phase 1); 3 to 25 or 39 years depending on cohort (Phase 2)
  • Karnofsky ≥50 (>16 years) or Lansky ≥50 (≤16 years)
  • ANC ≥1000/mm³, platelets ≥100,000/mm³, eGFR ≥60 mL/min
  • Stable or decreasing dexamethasone dose for at least 1 week

Key Exclusion

  • Received any systemic therapy or radiotherapy including investigational agents
  • History of allergic reactions to pegylated compounds
  • Phase 2: tumors with epicenter in pons or spinal cord
  • Metastatic or leptomeningeal disease
  • Uncontrolled infection or intercurrent illness
  • Pregnant or breast-feeding
  • QTc >480 ms
  • HIV-positive with unstable therapy regimen or severe immunocompromise

NCT06956781

Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

Organization/Sponsor: University of Rochester


Example patient: A 12-year-old child with PTSD from physical assault, IQ above 70, living with a non-perpetrator grandmother for six months, on stable SSRI medication for three months, with access to a smartphone.

Phase N/A

Interventions

  • Behavioral: Psychological Placebo
    Summary: An inactive control treatment providing baseline measurements, utilizing placebo effects and supportive care to reduce anxiety and improve well-being without specific active ingredients (NCI Thesaurus, Web Search).
  • Behavioral: Bi-lateral Stimulation
    Summary: A therapeutic intervention involving alternating sensory stimulation, commonly used in trauma-focused therapies to facilitate processing of traumatic memories and reduce distress (Web Search).
  • Behavioral: Cognitive Processing
    Summary: Cognitive Processing Therapy targets cognitive distortions and maladaptive beliefs related to trauma, restructuring negative thought patterns to improve coping strategies and mental health (Web Search).
  • Behavioral: Exposure
    Summary: Exposure therapy involves systematic confrontation with trauma-related memories, situations, or stimuli to reduce avoidance and distress through habituation and emotional processing (NCI Thesaurus, Web Search).
  • Behavioral: Emotion Regulation
    Summary: A psychological intervention employing cognitive and behavioral strategies to enhance coping skills, emotional awareness, and management of stress, anxiety, and depression (Web Search).

Key Inclusion

  • Child ages 8-17 exposed to at least one DSM-defined trauma
  • Meets PTSD diagnostic criteria from identified trauma
  • Stable caregiving environment for two months
  • Psychotropic medications stable for two months if applicable
  • Caregiver or child has smartphone for software application

Key Exclusion

  • Suicidal ideation with intent or current psychotic disorder
  • Intelligence quotient (IQ) less than 70
  • Currently receiving behavioral health intervention for PTSD or trauma
  • Caregiver is perpetrator of identified trauma
  • MRI contraindicators such as metal in body

NCT07506239

PNOC042: A Phase 2, Multi-institutional Trial, Evaluating the Efficacy of Laser Interstitial Thermal Therapy (LITT) in Children, Adolescents and Young Adults With Recurrent or Progressive Low-grade Gliomas (LGG)

Organization/Sponsor: University of California, San Francisco


Example patient: A 7-year-old with recurrent thalamic low-grade glioma measuring 4 cm after prior chemotherapy, stable on dexamethasone, with Lansky score of 60 and no midline shift.

Phase 2

Interventions

  • Procedure: Laser Interstitial Thermal Therapy (LITT)
    Summary: Minimally invasive treatment using laser to heat and destroy deep-seated brain tumor tissue, effective for pediatric low-grade gliomas with reduced tumor volume (Summary of Web Search).
  • Diagnostic Test: Magnetic resonance imaging (MRI)
    Summary: Diagnostic imaging using magnetic fields and radio waves to create detailed brain images for detecting, monitoring, and assessing treatment effectiveness in brain cancer (Summary of Web Search, NCI Thesaurus).
  • Other: Questionnaires
    Summary: Patient-reported outcome assessments measuring cognitive and physical function, quality of life, and symptom management in brain cancer patients (Summary of Web Search, NCI Thesaurus).

Key Inclusion

  • Recurrent or progressive pediatric LGG with at least one prior treatment
  • Histologically confirmed LGG determined suitable for LITT by central review
  • Tumor size up to 5 cm in largest dimension excluding cystic component
  • Tumor location accessible and safe for LITT per central review
  • Age 2 to 25 years
  • Karnofsky ≥50 (>16 years) or Lansky ≥50 (≤16 years)
  • Stable or decreasing dexamethasone dose for at least 1 week
  • Surgically eligible per institutional standards

Key Exclusion

  • Optic pathway gliomas
  • Spinal tumors
  • Infiltrative brainstem lesions
  • Uncontrolled leptomeningeal disease or extracranial disease
  • Untreated obstructive hydrocephalus or >10 mm midline shift
  • Symptomatic intratumoral hemorrhage Grade 3 or 4
  • Receiving other investigational agents
  • Ongoing or active uncontrolled infection

NCT07419490

A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)

Organization/Sponsor: University of South Florida


Example patient: A 32-year-old woman with newly diagnosed rectal cancer requiring pelvic radiotherapy, BMI 28, normal ovarian function tests, no metastases, desiring future pregnancy.

Phase 1

Interventions

  • Procedure: Uteroovarian transposition
    Summary: Surgical procedure relocating the uterus and ovaries outside the radiation field to preserve fertility and ovarian function in women undergoing pelvic radiotherapy for cancer treatment (NCI Thesaurus, Web Search).

Key Inclusion

  • Women 18-40 years of age who wish to preserve fertility
  • Diagnosis of pelvic malignancies requiring radiotherapy (colon, rectal, anal, or other pelvic cancers)
  • Normal ovarian function: FSH <10 IU/L, AMH >1 ng/mL, normal LH and estradiol
  • No distant metastasis confirmed by imaging
  • BMI <35
  • Desire to carry future pregnancy

Key Exclusion

  • Advanced cancer stage with locally advanced or metastatic disease
  • Prior pelvic radiotherapy
  • Significant uterine pathology (large fibroids, adenomyosis)
  • Poor ovarian reserve: FSH >10 IU/L or AMH <1 ng/mL
  • Severe cardiovascular, respiratory, or metabolic comorbidities contraindicating surgery
  • Currently pregnant
  • BMI ≥35
  • Absence of one of the gonadal vessels

NCT07346157

PNOC044: Liothyronine (L-T3) in Combination With Bevacizumab, Irinotecan and Temozolomide (BIT) for Progressive or Relapsed Medulloblastoma (Cohort 1) or as Monotherapy for Medulloblastoma With Minimal Residual Disease (Cohort 2) Genomic-based

Organization/Sponsor: University of California, San Francisco


Example patient: A 7-year-old child with relapsed medulloblastoma after craniospinal radiation, with measurable disease on MRI, Lansky score of 70, normal cardiac function, and CSF positive for cell-free DNA.

Phase 1, Phase 2

Interventions

  • Drug: Temozolomide (TMZ)
    Summary: Temozolomide is an alkylating agent that methylates DNA at O6 and N7 positions of guanine, inhibiting DNA replication and causing cell death. It is indicated for glioblastoma and anaplastic astrocytoma, penetrates the CNS well, and is administered orally. Sources: FDA label, NCI Thesaurus.
  • Drug: Irinotecan
    Summary: Irinotecan is a topoisomerase I inhibitor prodrug converted to active metabolite SN-38, which stabilizes the DNA-topoisomerase I complex causing DNA breaks and apoptosis. It is indicated for metastatic colorectal cancer and is S-phase specific. Sources: FDA label, NCI Thesaurus.
  • Biological: Bevacizumab
    Summary: Bevacizumab is a recombinant humanized monoclonal antibody that binds VEGF, blocking angiogenesis by preventing tumor blood vessel formation and maintenance. It is indicated for multiple advanced cancers including glioblastoma, typically combined with chemotherapy. Sources: FDA label, NCI Thesaurus.
  • Drug: Liothyronine (L-T3)
    Summary: Liothyronine sodium is synthetic triiodothyronine (T3) that binds nuclear thyroid receptors to induce gene expression for normal growth and development. It is more potent with faster onset than T4, indicated for myxedema coma and thyroid replacement. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Histologically confirmed medulloblastoma that is relapsed/progressive following standard upfront therapy
  • Age 1-25 years old
  • Karnofsky ≥50 for >16 years or Lansky ≥50 for ≤16 years
  • Phase 2 Cohort 2: CSF with cell-free DNA positive
  • Prior standard upfront therapy (craniospinal radiation or high dose chemotherapy with autologous stem cell rescue)
  • Phase 2 Cohort 1: at least one and at most two relapses prior to enrollment
  • ANC ≥1000/mm3, platelets ≥75,000/uL transfusion independent
  • Normal cardiac function (LVEF >55% or SF >28%) and no clinically significant arrhythmia

Key Exclusion

  • Cohort 1: previously treated with BIT in combination
  • Myelosuppressive chemotherapy within 3 weeks or not recovered from prior agents
  • Strong CYP450 inhibitors or inducers
  • Diagnosis of Graves' Disease or pre-existing hyperthyroid disease
  • Previous or active cardiovascular disease including heart failure, myocardial infarction, or cardiomyopathy
  • Uncontrolled systemic hypertension (>95th percentile if ≤17 years)
  • Uncontrolled diabetes mellitus (HbA1c >8%) or diabetes insipidus
  • Pregnant or breast-feeding women

NCT07417202

Intraoperative Wound Irrigation for Pilonidal Disease: A Randomized Controlled Trial

Organization/Sponsor: Stanford University


Example patient: A 22-year-old male with stage 3 pilonidal disease requiring surgical intervention with intraoperative wound irrigation.

Phase N/A

Interventions

  • Drug: Hypochlorous Acid
    Summary: An over-the-counter antimicrobial oxidizing solution that kills bacteria and creates a wound microenvironment favorable to healing by inhibiting NF-kB inflammatory pathways and inactivating matrix metalloproteases, used for wound cleaning and infection prevention (FDA label, NCI Thesaurus).

Key Inclusion

  • Stage 3 pilonidal disease according to the Stanford Pilonidal Severity Staging System

Key Exclusion

  • Pilonidal disease that is not classified as stage 3
  • Intellectual disability precluding the patient and/or guardian from being able to consent

NCT07382739

A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) "PRIME-EMD-PMD"

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 62-year-old with relapsed multiple myeloma after five prior therapies including lenalidomide, bortezomib, and daratumumab, presenting with extramedullary plasmacytoma in soft tissue and adequate organ function.

Phase 2

Interventions

  • Biological: Elranatamab
    Summary: Elranatamab-bcmm (ELREXFIO) is a bispecific antibody targeting CD3 on T-cells and BCMA on malignant plasma cells, inducing cytotoxic T-cell response against BCMA-expressing myeloma cells. FDA-approved for relapsed/refractory multiple myeloma after four prior therapies under accelerated approval (FDA label, NCI Thesaurus).

Key Inclusion

  • Relapsed or refractory multiple myeloma exposed to IMID, PI, anti-CD38 mAb
  • At least one prior line of therapy with progression on or after last regimen
  • At least one locus of extramedullary or paramedullary disease on imaging
  • EMD/PMD locus not previously radiated and amenable to radiation
  • Hemoglobin ≥7g/dL, platelets ≥50K/uL, ANC ≥0.75K/uL
  • Creatinine clearance ≥30mL/min/1.73m2
  • ECOG performance status ≤2
  • Negative pregnancy test for childbearing age females

Key Exclusion

  • Prior investigational treatment within 14 days or 5 half-lives
  • IMID, PI, anti-CD38 mAb, or cytotoxic myeloma therapy within 7 days
  • Autologous stem-cell transplant within 12 weeks or allogeneic within 6 months
  • Waldenstrom, POEMS, amyloidosis, or ongoing plasma cell leukemia
  • Active uncontrolled hepatitis B infection despite antiviral therapy
  • Uncontrolled infections or autoimmune disease requiring systemic treatment
  • Other active malignancies within 5 years with more than minimal recurrence risk
  • History of allergic reactions to elranatamab or similar compounds

NCT06492954

Phase 1b Trial of Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery in Patients With Pulmonary Recurrence of Osteosarcoma

Organization/Sponsor: Emory University


Example patient: A 14-year-old with second relapse of osteosarcoma presenting with three resectable bilateral lung nodules (largest 8 mm), Lansky score 80, adequate organ function, and no extrapulmonary disease.

Phase 1

Interventions

  • Biological: Atezolizumab
    Summary: Humanized monoclonal antibody blocking PD-L1 to enhance T-cell immune response against tumors; FDA-approved for multiple cancers including lung cancer and melanoma; Fc-optimized to avoid ADCC/CDC (FDA label, NCI Thesaurus).
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
    Summary: High-precision radiation delivering maximum dose to body tumors while sparing healthy tissue; effective for early-stage and metastatic lung cancers (NCI Thesaurus, Web Search).
  • Procedure: Surgical Resection
    Summary: Surgical removal of tumor tissue to achieve complete resection; primary treatment in pediatric cancer often followed by adjuvant therapy (NCI Thesaurus, Web Search).

Key Inclusion

  • Histologically verified osteosarcoma at original diagnosis or relapse
  • First or greater relapse of osteosarcoma
  • Recurrence limited to lung (unilateral or bilateral)
  • All pulmonary nodules resectable without pneumonectomy
  • At least 1 lesion ≥5 mm eligible for SBRT plus additional resectable nodule(s)
  • Karnofsky/Lansky score ≥60 or ECOG ≤2
  • Adequate organ function (bone marrow, renal, hepatic, cardiac, pulmonary)
  • Life expectancy at least 4 months

Key Exclusion

  • Active metastatic disease outside lungs (bone, CNS, extrapulmonary)
  • Prior lung radiation
  • Active autoimmune disorder requiring systemic treatment in past 12 months
  • Significant cardiovascular disease within 3 months
  • Prior allogeneic stem cell or solid organ transplant
  • Current or prior pneumonitis
  • Chronic immunosuppressive therapies
  • Pregnancy or breastfeeding

NCT07302230

The EMPOWER Trial: Evaluating a Home-Based Physical Activity Program (PAP) With the ExerciseRx™ Digital Platform vs. Health Education Group (HEG) in People With Non-Muscle Invasive Bladder Cancer

Organization/Sponsor: University of Washington


Example patient: A 62-year-old English-speaking adult with non-muscle invasive bladder cancer on intravesical maintenance therapy, classified as insufficiently active, ambulatory, owns a smartphone, and receives care at University of Washington.

Phase N/A

Interventions

  • Procedure: Electronic Health Record Review
    Summary: Involves analyzing patient data from electronic health records to assess physical activity and quality of life outcomes (NCI Thesaurus).
  • Procedure: Interview
    Summary: Qualitative method gathering patient-reported outcomes and experiences through structured conversations (NCI Thesaurus).
  • Procedure: Questionnaire Administration
    Summary: Collects self-reported data on quality of life, psychological and physical impacts of treatment (NCI Thesaurus).
  • Behavioral: Educational Intervention
    Summary: Educational activity using lectures, brochures, and multimedia to improve knowledge and address lifestyle changes (NCI Thesaurus).
  • Device: Health Telemonitoring
    Summary: Uses digital tools for remote health monitoring via video, audio, and telecommunication methods (NCI Thesaurus).
  • Behavioral: Exercise Intervention
    Summary: Managed physical activity program to improve health, reduce fatigue, and enhance quality of life (NCI Thesaurus).
  • Other: Best Practice
    Summary: Informed treatment recommendation expected to benefit the greatest number of patients in a group (NCI Thesaurus).
  • Behavioral: Internet-Based Intervention
    Summary: Program using internet platforms to modify behavior, targeting physical activity and mental well-being (NCI Thesaurus).

Key Inclusion

  • Adults age 18 years or older
  • Prior diagnosis of non-muscle invasive bladder cancer
  • Currently on surveillance or receiving maintenance intravesical therapy
  • Classified as insufficiently active on PAVS assessment
  • Has Android or Apple smartphone/tablet
  • Ambulatory
  • English-speaking
  • Willing to participate and sign informed consent

Key Exclusion

  • Severe cognitive or memory impairment/dementia
  • Inability to read or understand English
  • Lack of access to Android or iOS smart device
  • Not receiving treatment at University of Washington
  • Orthopedic, neurologic, or other problems preventing safe ambulation
  • Current diagnosis with muscle-invasive or metastatic bladder cancer
  • Uncontrolled or concurrent illness including active infection or cardiac issues
  • Participation in conflicting clinical trial

NCT07223463

A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer

Organization/Sponsor: Children's Hospital Medical Center, Cincinnati


Example patient: A 19-year-old English-speaking patient with leukemia prescribed oral chemotherapy who demonstrated 85% adherence during run-in and successfully used the electronic monitoring device.

Phase N/A

Interventions

  • Behavioral: Feedback Program (Uniform Standard of Care)
    Summary: Standardized feedback and quality improvement protocol to enhance pediatric cancer care and medication adherence through regular monitoring and feedback mechanisms (Web Search).
  • Behavioral: Tailored Program
    Summary: Individualized communication and behavioral interventions specific to patient needs to improve medication adherence and health outcomes (NCI Thesaurus).

Key Inclusion

  • Age 15.00 to 24.99 years
  • Diagnosed with cancer
  • Prescribed oral anticancer/antitumor agent or prophylaxis

Key Exclusion

  • Not fluent in English
  • Significant cognitive deficits
  • Medical status or treatment precludes participation
  • Enrolled on trial requiring medication storage in trial-provided container
  • Greater than or equal to 95% adherence during run-in period
  • Declines to use or has difficulty using electronic adherence monitoring device during run-in

NCT07457918

COVE-4: A Phase 3, Open-Label, Long-Term Follow-Up Study to Evaluate the Safety and Efficacy of YCANTH (VP-102/TO-208) in Subjects With Common Warts (Verruca Vulgaris)

Organization/Sponsor: Verrica Pharmaceuticals Inc.


Example patient: A 14-year-old male who completed Day 84 of the parent study with three persistent common warts on his hands, not immunosuppressed, willing to avoid swimming until drug removal, and using no other wart treatments.

Phase 3

Interventions

  • Drug: Cantharidin
    Summary: YCANTH is a topical solution containing cantharidin, a naturally-derived lipophilic compound applied directly to skin lesions. FDA-approved for molluscum contagiosum in patients aged 2 years and older, it is being studied for common warts treatment. Source: FDA label.

Key Inclusion

  • Completed Day 84, 105, or 147 visit in parent study
  • Have at least 1 treatable common wart
  • Pediatric and adult subjects with parent/guardian consent or self-consent
  • Agree to refrain from swimming or water immersion until study drug removed
  • Willing to avoid other wart-removing products during study
  • Females of childbearing potential must use responsible birth control methods
  • Negative urine pregnancy test required before each treatment for post-menarchal females
  • Ability to follow study instructions and complete all requirements

Key Exclusion

  • Systemically immunosuppressed or immunomodulatory medication within 30 days
  • Chronic conditions that may interfere with study or place subject at risk
  • Previous common wart treatment within 90 days before enrollment
  • Immunizations within 5 days before or after study drug treatment
  • Active malignancy or undergoing cancer treatment
  • Epidermodysplasia verruciformis
  • Hypersensitivity to cantharidin or drug excipients
  • Pregnant or breastfeeding

NCT07471685

Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors

Organization/Sponsor: Duke University


Example patient: A 25-year-old female lymphoma survivor who completed chemotherapy with alkylating agents at age 22, desires future children, and seeks guidance on family-building options.

Phase N/A

Interventions

  • Behavioral: Survivorship Education
    Summary: A document containing cancer treatment history and guidelines for monitoring health, including future check-ups and potential long-term late effects (NCI Thesaurus).
  • Behavioral: Nurse Navigator-Delivered Family Building Decision Support
    Summary: Provides emotional and informational support to female AYA cancer survivors for family-building decisions, reducing uncertainty and improving decision-making through videoconference sessions (Web Search Summary).

Key Inclusion

  • Female AYA cancer survivor age 15-39 at diagnosis and 18-39 at enrollment
  • Completed cancer treatment with curative intent
  • Prior gonadotoxic treatment exposure (alkylating agents, total body irradiation)
  • Prior treatments increasing obstetric risk (chest radiation, uterine radiation, anthracyclines)
  • Has not completed family building
  • Able to speak and read English
  • Willing to complete videoconference sessions and REDCap surveys

Key Exclusion

  • Visual impairment interfering with participation
  • Hearing impairment interfering with participation
  • Cognitive impairment interfering with participation
  • Severe mental illness interfering with participation

NCT07374315

A Family-based Intervention Approach to Address Weight Gain in Pediatric Leukemia Survivors

Organization/Sponsor: Washington University School of Medicine


Example patient: A 12-year-old English-speaking patient with B-cell ALL currently on maintenance chemotherapy, able to walk briskly for five minutes, with no eating disorder or severe mental illness, participating with their primary caregiver.

Phase N/A

Interventions

  • Behavioral: Modified Guided Self-Help Family Intervention
    Summary: Family-based counseling intervention targeting psychological support and coping strategies for families dealing with leukemia, using structured guidance and self-help techniques to improve emotional well-being (Summary of Web Search).
  • Device: FitBit Ace
    Summary: Wearable activity monitoring device that tracks movement and physical activity levels to encourage exercise and improve outcomes in pediatric cancer patients (Summary of Web Search).
  • Other: WashU Extended Learning Canvas
    Summary: Educational platform providing learning resources and support materials for study participants (Summary of Web Search).
  • Other: NIH Educational Resources
    Summary: Educational materials and interventions from NIH aimed at improving patient outcomes through targeted information and support (Summary of Web Search).

Key Inclusion

  • Diagnosis of ALL (T or B cell)
  • Receiving standard of care maintenance chemotherapy or within 6 months of concluding maintenance
  • Age 6 to 18 years at enrollment
  • Able to speak and understand English
  • Has participating caregiver
  • Able to perform exercise for at least five minutes
  • Patients 10+ must have negative SCOFF screen for disordered eating

Key Exclusion

  • Severe developmental delay or intellectual disabilities
  • Significant mental illness including active suicidal ideation, psychotic symptoms, manic episodes
  • Severe substance use disorder
  • SCOFF score of 2 or more (patients 10+)
  • Unable to perform any level of exercise
  • Unable to speak or understand English

NCT07477457

OstEvo - Osteosarcoma Evolves

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 14-year-old with newly diagnosed osteosarcoma of the femur with lung and bone metastases, Lansky score 70%, normal cardiac and renal function, willing to undergo research biopsies.

Phase N/A

Interventions

  • Procedure: Biopsy
    Summary: Tissue removal procedure for microscopic examination to establish diagnosis and obtain research specimens for understanding mechanisms of response and resistance in osteosarcoma (NCI Thesaurus).
  • Drug: Ifosfamide
    Summary: Alkylating chemotherapy agent that forms DNA crosslinks preventing replication; indicated for germ cell testicular cancer; must be used with mesna to prevent hemorrhagic cystitis (FDA label, NCI Thesaurus).
  • Drug: Sunitinib
    Summary: Multi-targeted tyrosine kinase inhibitor blocking VEGFR2, PDGFRb, and c-kit to inhibit angiogenesis and tumor cell proliferation; indicated for GIST, RCC, and pNET (FDA label, NCI Thesaurus).
  • Drug: Disulfiram
    Summary: Proteasome inhibitor with antineoplastic activity when chelated with copper; generates ROS and inhibits cancer-specific pathways leading to apoptosis; also used in alcoholism treatment (FDA label, NCI Thesaurus).
  • Drug: Trametinib
    Summary: MEK 1/2 inhibitor blocking RAS/RAF/MEK/ERK signaling pathway; indicated for BRAF V600E/K mutation-positive melanoma, NSCLC, thyroid cancer, and pediatric low-grade glioma (FDA label, NCI Thesaurus).
  • Drug: Gefitinib
    Summary: EGFR tyrosine kinase inhibitor competing with ATP binding to inhibit receptor autophosphorylation; indicated for first-line metastatic NSCLC with exon 19 deletions or L858R mutations (FDA label, NCI Thesaurus).
  • Drug: Cisplatin
    Summary: Platinum-based alkylating agent forming DNA crosslinks causing apoptosis; indicated for testicular, ovarian, and bladder cancers; requires monitoring for nephrotoxicity, ototoxicity, and myelosuppression (FDA label, NCI Thesaurus).
  • Drug: Doxorubicin
    Summary: Anthracycline antibiotic intercalating DNA and inhibiting topoisomerase II; indicated for breast cancer, leukemias, lymphomas, and solid tumors; key toxicity is dose-dependent cardiotoxicity (FDA label, NCI Thesaurus).
  • Drug: Methotrexate
    Summary: Dihydrofolate reductase inhibitor blocking DNA synthesis; used in pediatric acute lymphoblastic leukemia and various pediatric cancers (Web Search Summary).

Key Inclusion

  • Newly diagnosed metastatic osteosarcoma with extrapulmonary metastasis or unresectable disease (Cohort 1)
  • Relapsed metastatic osteosarcoma after complete response within 24 months or involving multiple sites (Cohort 2)
  • Age >6 and <50 years (Cohorts 1 and 2)
  • Karnofsky ≥50% (>16 years) or Lansky ≥50 (<16 years)
  • Adequate organ function: ANC >250, platelets >50,000, GFR >70 mL/min/1.73m2, bilirubin <1.5x ULN
  • LVEF >55% and QTcF <480 msec
  • Willing to undergo research biopsies and enrolled on MSK IRB 12-245
  • Adequate contraception during and 12 months after treatment

Key Exclusion

  • Receiving other investigational agents for osteosarcoma
  • Uncontrolled infection or contraindication to OstEvo components
  • Heart disease including uncontrolled hypertension, cardiac dysrhythmias ≥grade 2, unstable angina, CHF, or prior MI
  • Receiving additional medicines for cancer treatment (excluding alternative medications)
  • Medical or surgical conditions interfering with GI absorption of oral agents
  • Prior cardiac irradiation
  • Previously enrolled in OstEvo (Cohort 2 only)