Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer (CERPASS)
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| ClinicalTrials.gov Identifier: NCT04050436 |
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Recruitment Status :
Recruiting
First Posted : August 8, 2019
Last Update Posted : December 23, 2020
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Sponsor:
Replimune Inc.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Replimune Inc.
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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) according to central review.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cutaneous Squamous Cell Carcinoma Advanced Cutaneous Squamous Cell Carcinoma Metastatic Cutaneous Squamous Cell Carcinoma | Drug: Cemiplimab Biological: RP1 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 8, 2019 |
| Estimated Primary Completion Date : | October 2022 |
| Estimated Study Completion Date : | March 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cemiplimab in combination with RP1
Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
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Drug: Cemiplimab
Cemiplimab administered intravenously
Other Name: Libtayo Biological: RP1 RP1 administered intratumorally
Other Name: Genetically modified herpes simplex type 1 virus |
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Active Comparator: Cemiplimab
Cemiplimab administered intravenously as a single therapy every 3 weeks
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Drug: Cemiplimab
Cemiplimab administered intravenously
Other Name: Libtayo |
Primary Outcome Measures :
- Objective Response Rate (ORR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 according to central review [ Time Frame: 36 months ]
Secondary Outcome Measures :
- ORR for patients with metastatic or locally advanced disease [ Time Frame: 36 months ]
- ORR for patients who have and have not previously received systemic CSCC-directed therapy [ Time Frame: 36 months ]
- ORR by investigator assessment [ Time Frame: approximately 36 months ]
- Rate of individual tumor response in injected versus non-injected lesions [ Time Frame: 36 months ]
- Duration of Response (DOR) per central and investigator review [ Time Frame: 36 months ]
- Progression-free Survival (PFS) per central and investigator review [ Time Frame: 36 months ]
- Complete response (CR) rate per central and investigator review [ Time Frame: 36 months ]
- Overall Survival (OS) [ Time Frame: approximately 36 months ]
- Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs) [ Time Frame: 36 months ]Overall adverse event rates and adverse event rates per observation period will be compared for the two treatment groups using a two-sided Fisher Exact test. Results will be analyzed by SOC and for preferred terms with >10% overall incidence.
- 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: 36 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
- Patients for whom surgical or radiological treatment of lesions is contraindicated
- At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
- 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.
- Known infection including active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050436
Contacts
| Contact: Clinical Trials at Replimune | 1-781-222-9570 | Clinicaltrials@replimune.com |
Locations
Show 23 study locations
Sponsors and Collaborators
Replimune Inc.
Regeneron Pharmaceuticals
Investigators
| Study Director: | Selda Samakoglu, MD, PhD | Senior Medical Director |
| Responsible Party: | Replimune Inc. |
| ClinicalTrials.gov Identifier: | NCT04050436 |
| Other Study ID Numbers: |
RPL-002-18 |
| First Posted: | August 8, 2019 Key Record Dates |
| Last Update Posted: | December 23, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Replimune Inc.:
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Oncolytic Virus Carcinoma Carcinoma, Squamous Cell |
Cemiplimab Metastatic Cutaneous Squamous Cell Carcinoma Oncolytic Immuno-gene therapy |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Cemiplimab Antineoplastic Agents, Immunological Antineoplastic Agents |