Replimune RP-001-16 (Non-melanoma skin)

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

NCT03767348

Non-melanoma skin cancer, basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma,

Stage 4

Metastatic/Palliative

No prior PD-1

RP1, nivolumab

oncolytic virus (HSV), PD-1 inhibitor

Ari VanderWalde, MD

Replimune, Inc.

Phase 2

Open to Enrollment

• Diagnosis of locally advanced or metastatic non-melanoma skin cancer not considered treatable by surgery. Could include;
  • Basal cell carcinoma,
  • Cutaneous squamous cell carcinoma,
  • Merkel cell carcinoma
  • Angiosarcoma of the skin
  • Eccrine carcinoma
  • high grade dermatofibroma protuberans
  • CTCL is NOT allowed
• Must have exhausted or refused currently available therapy
• ECOG PS 0-1
• At least one injectable tumor (visceral or deep nodal lesions may be injectable)
• Measurable disease by RECIST 1.1
• No prior oncolytic virus therapy (no prior T-VEC)
• No active CNS disease
• No history of major autoimmune disease
• No known HBV, HCV, or HIV
• No need for steroids >20mg prednisone daily or equivalent
• No need for chronic use of anti-virals (e.g. acyclovir)
• No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.

Primary- safety

Secondary- Biologic activity, CR rate, DoR, PFS

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Basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, basosquamous carcinoma, high-grade dermatofibroma protuberans, angiosarcoma of the skin, non-HIV-related Kaposi sarcoma, sebaceous gland carcinome, eccrine carcinomas

No