Clinical Trials for Brain Tumor

Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with progressive, measurable CNS metastases from solid tumors and CDK pathway alterations (Cohort 1) receive palbociclib, a selective CDK4/6 inhibitor, while patients with breast cancer brain metastases (Cohort 2) receive palbociclib plus pembrolizumab, an anti–PD-1 immunotherapy. Prior CNS-directed therapy is allowed; key exclusions include prior CDK4/6 inhibitor use, leptomeningeal disease (Cohort 1), and active autoimmune disease (Cohort 2).

ClinicalTrials.gov ID: NCT02896335

An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects with HER2-Negative Metastatic Breast Cancer with Brain Metastases and Abnormally Active HER2 Signaling

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with HER2-negative metastatic breast cancer and brain metastases whose tumors have abnormally active HER2 signaling (per CELsignia test), including both ER-positive and triple-negative subtypes, and treats them with the investigational HER2 pathway inhibitor neratinib plus capecitabine. Eligible patients must have appropriate prior treatment and be able to undergo biopsy and systemic therapy.

ClinicalTrials.gov ID: NCT04965064

An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with ER-positive, HER2-negative breast cancer and active, measurable brain metastases who have progressed on prior endocrine therapy (excluding prior abemaciclib in the metastatic setting), testing oral elacestrant (a selective estrogen receptor degrader) in combination with abemaciclib (a CDK4/6 inhibitor). The study excludes patients with leptomeningeal disease, imminent visceral crisis, or prior metastatic abemaciclib exposure.

ClinicalTrials.gov ID: NCT05386108

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: This trial enrolls adults with advanced HRR-mutated solid tumors—including previously treated breast, ovarian, fallopian tube, primary peritoneal, castration-resistant prostate, or pancreatic cancers—who may have had limited prior PARP inhibitor exposure and CNS metastases if stable. Patients receive EIK1004 (IMP1707), a highly selective CNS-penetrant PARP1 inhibitor, as oral monotherapy.

ClinicalTrials.gov ID: NCT06907043

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Eligible patients have metastatic breast cancer with at least two untreated brain metastases (≥5 mm), are ECOG 0-1, and may continue concurrent hormonal or anti-HER2 treatment; participants receive stereotactic radiosurgery (SRS) to one lesion followed by pembrolizumab, an anti-PD-1 monoclonal antibody immunotherapy, to assess responses in non-irradiated brain lesions and systemically. Prior SRS is permitted if new lesions are targeted, and key exclusions include active autoimmune disease and recent complete CNS resection.

ClinicalTrials.gov ID: NCT03449238

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: This trial enrolls adults with hormone receptor positive, HER2-negative metastatic breast cancer and up to 15 brain metastases (measurable by RANO-BM and eligible for SRS) to receive abemaciclib (a CDK4/6 inhibitor), endocrine therapy, and stereotactic radiosurgery. Patients must not have prior whole brain radiotherapy, leptomeningeal disease, or recent abemaciclib exposure.

ClinicalTrials.gov ID: NCT04923542

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This study enrolls female patients with triple negative, HER2+, or hormone receptor positive breast cancer and asymptomatic, measurable brain metastases, treating them with a personalized anti-HER2/HER3 dendritic cell vaccine (designed to enhance immune targeting of HER2/HER3-expressing cells) combined with the PD-1 inhibitor pembrolizumab. Eligible patients must have ECOG 0-1 and no immediate need for local brain therapy, leptomeningeal disease, or active autoimmune/infectious conditions.

ClinicalTrials.gov ID: NCT04348747

A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with histologically confirmed SCLC and up to 10 brain metastases (KPS 60–100/ECOG 0–2), without prior brain RT or leptomeningeal disease, receive stereotactic radiosurgery to all lesions. Designed to evaluate intracranial control and short-term survival (6-month OS) with focal SRS instead of whole-brain radiotherapy.

ClinicalTrials.gov ID: NCT05419076

A Single Arm Open Label Study to Determine the Safety and Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Recurrence of Glioma in Patients Who Received a Prior Treatment With 186RNL

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with histologically confirmed recurrent malignant glioma (WHO grade III–IV) who previously received 186RNL, eligible for stereotactic biopsy, are retreated with a single intratumoral infusion of rhenium-186 nanoliposomes via convection-enhanced delivery. 186RNL is a beta-emitting radionuclide encapsulated in nanoliposomes to deliver localized radiation to tumor tissue, with safety, dosimetry, and efficacy (ORR/PFS) assessed; key exclusions include multifocal/leptomeningeal disease and most infratentorial tumors.

ClinicalTrials.gov ID: NCT05460507

Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with solid-tumor brain metastases scheduled for WBRT (MMSE ≥24, KPS ≥70) receive intensity-modulated whole-brain radiotherapy delivering 30 Gy in 10 fractions while selectively sparing the genu of the corpus callosum. Intended for patients without genu involvement (prior SRS allowed, no prior WBRT), this approach aims to preserve cognition and neuropsychiatric function compared with standard WBRT.

ClinicalTrials.gov ID: NCT03223922