Trials / Active Not Recruiting
Active Not RecruitingNCT04050436
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 231 (actual)
- Sponsor
- Replimune, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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) and complete response rate (CRR) according to blinded independent review.
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 patients with advanced malignancies, and contains both single agent dose escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2 cohorts in individual tumor types.
Conditions
- Cutaneous Squamous Cell Carcinoma
- Advanced Cutaneous Squamous Cell Carcinoma
- Metastatic Cutaneous Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cemiplimab | Cemiplimab administered intravenously |
| BIOLOGICAL | RP1 | RP1 administered intratumorally |
Timeline
- Start date
- 2019-10-08
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
- First posted
- 2019-08-08
- Last updated
- 2025-01-27
Locations
56 sites across 10 countries: United States, Australia, Bulgaria, Canada, France, Germany, Greece, Italy, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04050436. Inclusion in this directory is not an endorsement.