MELANOMA: 1st or 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
Malignancy
Melanoma, Skin Cancer, ocular melanoma, mucosal melanoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st or 2nd
Investigational Agent
RP1 + nivolumab
Drug Class
Oncolytic virus
PI
Ari VanderWalde, MD
Sponsor
Replimune Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Stage IIIB-IV melanoma, either PD-1 naive or 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
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Assessment Frequency Link
Path
Melanoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X