Description:
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.
Title
- Brief Title: Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
RPL-002-18
- NCT ID:
NCT04050436
Conditions
- Cutaneous Squamous Cell Carcinoma
- Advanced Cutaneous Squamous Cell Carcinoma
- Metastatic Cutaneous Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Cemiplimab | Libtayo | Cemiplimab |
RP1 | Genetically modified herpes simplex type 1 virus | Cemiplimab in combination with RP1 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cemiplimab in combination with RP1 | Experimental | Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks | |
Cemiplimab | Active Comparator | Cemiplimab administered intravenously as a single therapy every 3 weeks | |
Eligibility Criteria
Key Inclusion Criteria:
- 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
- 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 Criteria:
- 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) according to blinded independent review |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression Free Survival (PFS) by blinded independent review. |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Measure: | ORR/CRR by investigator assessment |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Measure: | ORR/CRR for patients with metastatic or locally advanced disease according to investigator review |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Measure: | ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) per investigator review |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Progression-free Survival (PFS) per investigator review |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | up to 5 years |
Safety Issue: | |
Description: | |
Measure: | 3-year survival |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | Change in overall scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
Time Frame: | approximately 30 months |
Safety Issue: | |
Description: | |
Measure: | Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs) |
Time Frame: | approximately 26 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Replimune Inc. |
Trial Keywords
- Oncolytic Virus
- Carcinoma
- Carcinoma, Squamous Cell
- Cemiplimab
- Metastatic Cutaneous Squamous Cell Carcinoma
- Oncolytic Immuno-gene therapy
Last Updated
June 28, 2021