West Cancer Center

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

Title

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

Study Title

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

Site Link

NCT03767348

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

Ari VanderWalde, MD

Sponsor

Replimune, Inc.

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

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.

Objective

Primary- safety

Secondary- Biologic activity, CR rate, DoR, PFS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

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

Dosing Frequency

Control Agents

Study Protocol

Randomized