West Cancer Center

MELANOMA: 2nd line: PD-1 + HSV-virus: RPL-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 RPL-001-16 (Melanoma)

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

Melanoma, Skin Cancer, ocular melanoma, mucosal melanoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd

Investigational Agent

RP1 + nivolumab

Drug Class

Oncolytic virus

Ari VanderWalde, MD

Sponsor

Replimune Inc.

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Stage IIIB-IV melanoma, following progression on PD-1 containing regimen
ECOG PS 0-1
At least one injectable tumor (visceral or deep nodal lesions may be injectable)
Measruable 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

Melanoma

Dosing Frequency

Control Agents

Study Protocol

Randomized