MG1-MAGEA3 With Ad-MAGEA3 and Pembrolizumab in Patients With Previously Treated Metastatic Melanoma or Cutaneous Squamous Cell Carcinoma

Launched by TURNSTONE BIOLOGICS, CORP. · Dec 11, 2018

Keywords

ClinConnect Summary

This is a Phase 1b open-label dose escalation trial of Ad/MG1-MAGEA3 and Pembrolizumab in patients with Metastatic Melanoma or Cutaneous Squamous Cell Skin Cancer that has failed prior standard of care treatments. This study will consist of two arms where the dose will be increased independently until the maximum tolerated dose (MTD) / maximum feasible dose (MFD) is reached.

Arm 1 - Low-dose cyclophosphamide, followed by an Ad-MAGEA3 intramuscular (IM) prime, followed by intravenous (IV) administration of MG1-MAGEA3 and IV pembrolizumab.

Arm 2 - Ad-MAGEA3 IM injection as a prime, followed...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have histologically or cytologically confirmed diagnosis of locally advanced metastatic melanoma or cutaneous squamous cell carcinoma that has failed standard therapies
• • For patients treated intratumorally, must have a lesion suitable for direct injection of MG1-MAGEA3
• • Have at least one tumor amenable to biopsy
• • Have measurable disease via RECIST 1.1 criteria
• • Adequate organ function and performance status
• • Additional inclusion criteria present
• Exclusion Criteria:
• • Prior treatment with any MAGE-A3 vaccine immunotherapy
• • Prior systemic therapy for cancer within 4 weeks (8 weeks for lung radiation), and has recovered from chemo-related toxicities to Grade 1 or less
• • Intolerant to prior PD1/PD-L1 therapy
• • Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
• • Known active CNS metastases and/or carcinomatous meningitis.
• • Active autoimmune disease that has required systemic therapy in the past 2 years.
• • Conditions likely to have resulted in splenic dysfunction.
• • Known HIV/AIDS, active HBV or HCV infection.
• • Additional Exclusion criteria exist