Physician

Neil Belman, DO

Study Coordinator

Cynthia Evancho
484-658-2534
Cynthia.Evancho@sluhn.org

Close

This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

Close

• Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

• Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

• Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

• Patients must be able to undergo MRI with contrast

• Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

• For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

• For TNBC, patients must have had at least one chemotherpy in the metastatic setting

• For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

• For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

• For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

• No known current diffuse leptomeningeal involvement

• No surgery within 2 weeks prior to or after registration

• No chemotherapy within 14 days prior to registration

Close

Physician

Tamam Habib, MD

Study Coordinator

Angela Rankin, RN
484-658-1792
Angela.Rankin@sluhn.org

Close

Synopsis: The purpose of this Study is to test the safety of the study drug, pembroluzimab (MK-3475), and test how your cancer responds to one of the following: pembroluzimab plus radiation therapy (RT) with or without cisplatin after surgery or RT with or without cisplatin after surgery.

Close

• Is ≥18 years of age, at the time of signing the informed consent
• Histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma - Clinical stage III oropharyngeal p16 positive that is T4 (N0-N2) M0, OR stage III or IVA oropharyngeal p16 negative, OR Stage III or IVA larynx, hypopharynx, oral cavity (independent of p16)
• Patients must be eligible for primary surgery as validated by members of a multidisciplinary team
• PD-L1 testing will be confirmed by a central lab during screening

Close