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

• Status: Withdrawn
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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. Upon determination of a Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) the study will be expanded into up to 24 additional Metastatic Melanoma patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turnstone Biologics, Corp.; Turnstone Biologics, Inc.
• Treatments: Cyclophosphamide; Pembrolizumab

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