Status:
ACTIVE_NOT_RECRUITING
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Lead Sponsor:
Replimune Inc.
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Cutaneous Squamous Cell Carcinoma
Advanced Cutaneous Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) a...
Detailed Description
RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with nivolumab in patien...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
- Patients with locally advanced disease who are not suitable candidates for surgical or radiological treatment of lesions or have refused those treatments
- At least 1 lesion that is measurable and injectable by study criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the CSCC disease under study
- Anticipated life expectancy \>12 weeks
- All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.
- Key
Exclusion
- Prior treatment with an oncolytic therapy
- Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)
- Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years.
- Untreated brain metastasis(es) that may be considered active.
- Acute or chronic active hepatitis B or known history of hepatitis B or hepatitis C or human immunodeficiency virus (HIV) infection
- History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
- Any major or surgical procedure ≤ 28 days before randomization
- Administration of live vaccines ≤ 28 days before randomization
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04050436
Start Date
October 8 2019
End Date
September 1 2025
Last Update
January 27 2025
Active Locations (56)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
University of California Los Angeles
Los Angeles, California, United States, 90024
3
Stanford University
Stanford, California, United States, 94305
4
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045