Brain Cancer Clinical Trials Intelligence
Monthly Update Report - October 2025
Powered by Sophic Starlight
Important Notice:
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.
1: Summary data from new trials identified for Brain Cancer.
Overview
Number of Trials: 5
These five trials span diverse approaches to brain and systemic cancers. Two trials focus on melanoma and small cell lung cancer brain metastases using immunotherapy, radiotherapy, and tumor-treating fields. One trial tests cognitive rehabilitation for non-glioblastoma brain tumor survivors. Another evaluates intraoperative fluorescence-guided surgery for high-grade gliomas. The fifth trial investigates sildenafil for preventing chemotherapy-related cognitive impairment in breast cancer patients.
Common Criteria Across Trials
Common Inclusion
- Age 18 years or older
- ECOG performance status 0-2 or Karnofsky ≥80
- Adequate organ and marrow function (normal liver, kidney, blood counts)
- Life expectancy greater than 6 months
- Ability to provide informed consent
- Histologically or radiologically confirmed cancer diagnosis
- Stable on CNS medications for at least one month
- Measurable or evaluable disease on imaging
Common Exclusion
- Pregnant or breastfeeding women
- Active uncontrolled infection
- Untreated or uncontrolled intercurrent illness
- Known HIV, Hepatitis B, or Hepatitis C
- Active autoimmune disease requiring systemic treatment
- Psychiatric or substance abuse disorders
- Prior radiotherapy to target site within specified timeframe
- Hypersensitivity to study drug or device components
- Vulnerable populations (children, prisoners, intellectually disabled)
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT04129515 — BRAF wild-type and mutated melanomas eligible; BRAF mutated patients must have progressed on or not tolerate BRAF/MEK targeted therapy
- NCT06930846 — Includes IDH mutant astrocytoma and oligodendroglioma subtypes
Unique or Unusual Criteria
- NCT04129515 — Requires willingness to comply with NovoTTF-200A device treatment for at least 75% of time; must have caregiver available to assist with transducer array exchange; excludes implanted pacemakers and defibrillators; excludes midline shift >5mm or papilledema
- NCT07139990 — Cohort B requires brain metastasis lesions 2-5 cm (brainstem 1.5-5 cm); allows 1-5 lesions only
- NCT06930846 — Requires subjective cognitive complaints; internet and telephone access for virtual sessions; includes service members, veterans, and civilians; excludes glioblastoma patients; allows caregiver participation
- NCT07111182 — Non-randomized design due to limited eligible patients and evolving surgical techniques
- NCT06800092 — Female-only, ages 30-50, premenopausal with menses in past 12 months; BMI <30; excludes nitrate use, alpha blockers, and PDE5 inhibitors within 2 weeks; blood pressure must be 90-170/50-110
Trials with Emerging Treatments
- NCT04129515 — Phase I and II Study of NovoTTF-200A and Pembrolizumab in Newly Diagnosed Melanoma Brain Metastasis
Items: NovoTTF-200A (Optune)
Note: NovoTTF-200A is a device delivering tumor-treating fields (TTFields) via low-intensity electric fields to disrupt cancer cell division in brain metastases; combined with pembrolizumab immunotherapy - NCT07139990 — Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)
Items: PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)
Note: PULSAR delivers personalized ultrahypofractionated stereotactic ablative radiotherapy in fewer high-dose sessions for brain metastases and extensive-stage small cell lung cancer thoracic tumors - NCT06930846 — HOBSCOTCH-CA
Items: HOBSCOTCH-CA (Home-Based Self-management and Cognitive Training)
Note: Virtual cognitive rehabilitation program using coaching and problem-solving strategies to improve cognitive function and quality of life in non-glioblastoma brain tumor survivors - NCT07111182 — ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring
Items: HIVEN Medical Device, 5-ALA fluorescence-guided surgery
Note: Intraoperative fluorescence-guided aspirate tissue monitoring device used with 5-ALA during high-grade glioma resection to improve tumor visualization and resection completeness
3: Individual Trial Overviews
NCT04129515
Phase I and II Study of NovoTTF-200A and Pembrolizumab in Newly Diagnosed Melanoma Brain Metastasis Genomic-based
Organization/Sponsor: Brown University
Example patient: A 52-year-old with BRAF-mutant melanoma who progressed on dabrafenib/trametinib, now presenting with three newly diagnosed brain metastases (largest 15mm), ECOG 1, no leptomeningeal disease, and adequate organ function.
Phase 1, Phase 2
NCT04129515
Phase I and II Study of NovoTTF-200A and Pembrolizumab in Newly Diagnosed Melanoma Brain Metastasis Genomic-based
Organization/Sponsor: Brown University
Example patient: A 52-year-old with BRAF-mutant melanoma who progressed on dabrafenib/trametinib, now presenting with three newly diagnosed brain metastases (largest 15mm), ECOG 1, no leptomeningeal disease, and adequate organ function.
Phase 1, Phase 2
Interventions
-
Biological: Pembrolizumab
Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor to enhance T-cell-mediated immune responses against tumor cells; FDA-approved for melanoma and other cancers by preventing PD-1/PD-L1 interaction (FDA label, NCI Thesaurus). -
Device: NovoTTF-200A
Summary: Device delivering low-intensity alternating electric tumor-treating fields (TTFields) to disrupt cancer cell division in brain tumors; targets mitotic spindle formation during cell division (Web Search).
Key Inclusion
- Histologically confirmed melanoma metastatic to brain (M1d)
- Measurable brain lesions ≥10 mm by MRI (Phase 2)
- Age 18 or above
- ECOG performance status 0-1 or Karnofsky ≥80
- At least 1 untreated brain metastasis for assessment
- BRAF mutated patients must have progressed on or not tolerate BRAF/MEK therapy
- Willing to comply with NovoTTF-200A device ≥75% of time
- Normal organ and marrow function
Key Exclusion
- Chemotherapy or radiotherapy within 4 weeks prior to treatment
- Known leptomeningeal metastasis
- Systemic steroids ≥4 mg daily dexamethasone equivalent within 7 days
- Active autoimmune disease requiring systemic treatment in past 2 years
- Implanted pacemaker, defibrillator, or deep brain stimulator
- Evidence of increased intracranial pressure (midline shift >5mm, papilledema)
- Pregnant or breastfeeding women
- Active infection requiring systemic therapy
NCT07139990
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types
Organization/Sponsor: University of Texas Southwestern Medical Center
Example patient: A 62-year-old with ECOG 1 performance status and newly diagnosed extensive stage small cell lung cancer receiving second cycle of chemoimmunotherapy, eligible for thoracic radiotherapy without prior chest radiation.
Phase N/A
NCT07139990
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types
Organization/Sponsor: University of Texas Southwestern Medical Center
Example patient: A 62-year-old with ECOG 1 performance status and newly diagnosed extensive stage small cell lung cancer receiving second cycle of chemoimmunotherapy, eligible for thoracic radiotherapy without prior chest radiation.
Phase N/A
Interventions
-
Radiation: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)
Summary: Personalized ultrahypofractionated stereotactic ablative radiotherapy delivers high-dose radiation to brain metastases in fewer sessions using precise targeting for effective local control. Source: Summary of Web Search. -
Radiation: ES-SCLC Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)
Summary: Personalized ultrahypofractionated stereotactic ablative radiotherapy for extensive-stage small cell lung cancer thoracic tumors delivers high doses in fewer sessions to maximize tumor control while minimizing side effects. Source: Summary of Web Search.
Key Inclusion
- 18 years or older
- Cohort A: Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days
- Cohort A: ECOG performance status 0-2
- Cohort A: Planned for or receiving standard chemoimmunotherapy with no more than 3 cycles
- Cohort B: Solid tumor malignancy with 1-5 MRI-defined brain metastasis lesions within 60 days
- Cohort B: Brain metastases 2-5 cm (or 1.5-5 cm for brainstem lesions)
Key Exclusion
- Cohort A: Prior thoracic radiotherapy
- Cohort B: Prior whole brain radiotherapy
- Cohort B: Prior surgical resection or focal radiotherapy of target brain metastasis
- Cohort B: Leptomeningeal disease
NCT06930846
HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer) Genomic-based
Organization/Sponsor: Dartmouth-Hitchcock Medical Center
Example patient: A 45-year-old veteran with IDH mutant astrocytoma who completed radiation six months ago, stable on antiepileptic medication, experiencing memory difficulties and seeking cognitive rehabilitation.
Phase N/A
NCT06930846
HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer) Genomic-based
Organization/Sponsor: Dartmouth-Hitchcock Medical Center
Example patient: A 45-year-old veteran with IDH mutant astrocytoma who completed radiation six months ago, stable on antiepileptic medication, experiencing memory difficulties and seeking cognitive rehabilitation.
Phase N/A
Interventions
-
Behavioral: HOBSCOTCH-CA
Summary: A home-based virtual coaching program using self-management and cognitive training strategies to improve cognitive function and quality of life in brain cancer survivors (Source: Web Search).
Key Inclusion
- 18+ years
- Diagnosis of primary brain tumor excluding glioblastoma with expected survival ≥2 years
- Low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, or meningioma
- Completed surgery and/or radiation therapy at least 3 months prior
- Stable on CNS medications for one month
- Subjective cognitive complaints
- English proficiency and internet/telephone access
Key Exclusion
- Glioblastoma diagnosis
- Neurodegenerative disease (Alzheimer's, Parkinson's)
- Acute psychiatric disorder or substance abuse
NCT07111182
ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
Organization/Sponsor: University of Illinois at Chicago
Example patient: A 52-year-old adult with suspected grade 4 glioblastoma scheduled for surgical resection with 5-ALA fluorescence guidance who provided informed consent.
Phase N/A
NCT07111182
ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
Organization/Sponsor: University of Illinois at Chicago
Example patient: A 52-year-old adult with suspected grade 4 glioblastoma scheduled for surgical resection with 5-ALA fluorescence guidance who provided informed consent.
Phase N/A
Interventions
-
Device: HIVEN Medical Device
Summary: A medical device used for intraoperative fluorescence-guided monitoring during brain tumor surgery to detect 5-ALA fluorescence in aspirated tissue for prevention, diagnosis, monitoring, or treatment purposes (NCI Thesaurus).
Key Inclusion
- Surgical resection of suspected grade 3 or 4 glioma with 5-ALA (cases)
- Surgical resection of primary or secondary brain tumor without 5-ALA (controls)
- Patients aged 18 years or older
- Informed consent obtained
- Admitted to neurosurgery department
Key Exclusion
- Children
- Pregnant patients
- Prisoners
- Intellectually disabled patients
NCT06800092
Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment Genomic-based
Organization/Sponsor: The University of Texas Medical Branch, Galveston
Example patient: A 42-year-old premenopausal woman with newly diagnosed ER-positive, HER2-negative breast cancer, BMI 27, no prior chemotherapy, normal blood pressure, and no cognitive impairment seeking to prevent treatment-related cognitive decline.
Phase N/A
NCT06800092
Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment Genomic-based
Organization/Sponsor: The University of Texas Medical Branch, Galveston
Example patient: A 42-year-old premenopausal woman with newly diagnosed ER-positive, HER2-negative breast cancer, BMI 27, no prior chemotherapy, normal blood pressure, and no cognitive impairment seeking to prevent treatment-related cognitive decline.
Phase N/A
Interventions
-
Drug: Sildenafil
Summary: Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor that selectively blocks cGMP degradation, causing smooth muscle relaxation and vasodilation. FDA-approved for pulmonary arterial hypertension and erectile dysfunction, it may reduce airway inflammation and improve cerebral blood flow. Sources: FDA label, NCI Thesaurus.
Key Inclusion
- Female
- Ages 30-50 years
- Self-reported menses within past 12 months
- Diagnosis of ER+/HER2- breast cancer
- Willing and able to comply with study procedures
- Willing and able to provide consent
Key Exclusion
- Untreated thyroid disorder or diabetes
- BMI >30
- Current metformin treatment
- Prior chemotherapy treatment
- Prior history of cognitive impairment
- Blood pressure <90/50 or >170/110
- Use of nitrates, alpha blockers, or PDE5 inhibitors in past 2 weeks
- MRI incompatible devices or severe claustrophobia