MelanomaOpen to EnrollmentPhase 2

SKIN CANCER: Non-melanoma: PD-1 eligible: PD-1 and oncolytic virus: RP-001-16

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

Study snapshot

Title: Replimune RP-001-16 (Non-melanoma skin)
Malignancy: Non-melanoma skin cancer, basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma,
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: No prior PD-1
Investigational agent: RP1, nivolumab
Drug class: oncolytic virus (HSV), PD-1 inhibitor
Principal investigator: Ari VanderWalde, MD
Sponsor: Replimune, Inc.
Path: 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
Randomized: No
ClinicalTrials.gov ID: NCT03767348

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