Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer (CERPASS)

STATUS

Recruiting
End date

Mar 28, 2025
participants needed

180
sponsor

Replimune Inc.

Updated on 4 October 2022

See if I qualify

cancer

skin cancer

cemiplimab

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.

Details

Condition	Cutaneous Squamous Cell Carcinoma, Advanced Cutaneous Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma
Treatment	Cemiplimab, RP1
Clinical Study Identifier	NCT04050436
Sponsor	Replimune Inc.
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
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. 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
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
	Note: Other protocol defined Inclusion/Exclusion criteria apply
	Any major or surgical procedure ≤ 28 days before randomization
	Administration of live vaccines ≤ 28 days before randomization

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Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer (CERPASS)