A Phase Ib Multi-Cohort Study of MK-3475 in Subjects with Advanced Solid Tumors
Johns Hopkins Kimmel Cancer Center in Baltimore
To determine the safety and tolerability of MK-3475, and to see if MK-3475 has anti-tumor activity in subjects with PD-L1 postiive advanced solid tumors
Must have histologically or cytologically-confirmed diagnosis of caner that is recurrent, metastatic, or persistentdiseases under study are:1. triple negative breast cancer2. squamous cell carcinoma of the head and neck3. urothelial tract cancer of the renal pelvis, ureter, blader, or urethra. Both transitional cell and non-transitional cell histologies are allowed.Must have archival or newly obtained core/biopsy.Have a PD-L1 positive tumor.Must have measurable disease based on irRC.Performance status 0 - 1.Adequate organ function.No chronic systemic steroids.No known secondary cancer that is progressing or requires active treatment. Some exceptions may apply.No known active central nervous system metastases and/or carcinomatous meningitis. May have previously treated stable brain mets as demonstrated by imaging at least 4 weeks prior to first dose.No active or documented history of autoimmune disease.no evidence of interstitial lung disease.no active infection requiring systemic therapy.No known psychiatric or substance abuse disorders.No prior therapy with an anti-PD-L1, anti PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA 4) antibodyNo known history of HIV.
All patients will receive MK-3475 as a 30 minute intravenous infusion every 2 weeks until disease progression, unacceptable toxicities, or patient withdraws from the study.Patients who attain a complete response may consider stopping the study treatment if they meet criteria for holding therapy. Patients may re-start treatment if their disease progresses.
07/29/2015 09:39 AM