Ended Therapeutic exploratory (Phase II) Cutaneous Squamous Cell Carcinoma

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

EU CTIS ID: 2024-512652-38-00

What this study is testing

The primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or nodal or distant metastatic cutaneous squamous cell carcinoma (CSCC), as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Voluntary agreement to provide written informed consent and willingness and ability to comply with protocol requirements.
ECOG performance status (PS) ≤1 (Appendix 4). Note: Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the disease under study (ie, CSCC), and they fulfill all other eligibility criteria, and upon consultation with the medical monitor.
Male or female ≥18 years old.
Hepatic function: a. Total bilirubin ≤1.5 × upper limit of normal (ULN); (if liver metastases ≤3 × ULN). Patients with Gilbert’s Disease and total bilirubin up to 3 × ULN may be eligible after communication with and approval from the medical monitor b. Transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) ≤3 × ULN (or ≤5.0 × ULN, if liver metastases) c. Alkaline phosphatase (ALP) ≤2.5 x ULN (or ≤5.0 x ULN, if liver or bone metastases) Note for patients with hepatic metastases who wish to enroll: If transaminase levels (AST and/or ALT) are >3 × but ≤5 × ULN, total bilirubin must be ≤1.5 × ULN. If total bilirubin is >1.5 × but ≤3 × ULN, both transaminases (AST and ALT) must be ≤3 × ULN.
7. Νεφρική λειτουργία: Κρεατινίνη ορού ≤1,5 × ΑΦΤ Ή, εάν η κρεατινίνη ορού > 1,5 × ΑΦΤ, υπολογιζόμενη κάθαρση κρεατινίνης ≥ 30 mL/min (με Cockcroft).
Bone marrow function: a. Hemoglobin ≥9.0 g/dL b. Absolute neutrophil count (ANC) ≥1.5 × 109/L c. Platelet count ≥100 × 109/L

You likely can't join if

Prior treatment with an oncolytic therapy.
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for ImAEs or a diagnosis of immunodeficiency disorders (such as human immunodeficiency virus [HIV] disease or organ transplantation or hematologic malignancies associated with immune suppression). Note: The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, alopecia areata or psoriasis that does not require systemic treatment.
Prior treatment with an agent that blocks the programmed cell death-1 (receptor) (PD-1)/PD-L1 pathway
Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years. Examples of immune modulating agents include therapeutic anticancer vaccines, cytokine treatments (other than granulocyte colony-stimulating factor [G-CSF] or erythropoietin), or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), PI 3-K-delta, or OX-40.
Untreated brain metastasis(es) that are considered active. See exclusion criteria in the protocol for exceptions for brain metastases (Section 4.2.2).
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to randomization/enrollment. See exclusion criteria in protocol for exceptions for corticosteroids (Section 4.2.2).

See the full eligibility criteria

Who can join

Voluntary agreement to provide written informed consent and willingness and ability to comply with protocol requirements.
ECOG performance status (PS) ≤1 (Appendix 4). Note: Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the disease under study (ie, CSCC), and they fulfill all other eligibility criteria, and upon consultation with the medical monitor.
Male or female ≥18 years old.
Hepatic function: a. Total bilirubin ≤1.5 × upper limit of normal (ULN); (if liver metastases ≤3 × ULN). Patients with Gilbert’s Disease and total bilirubin up to 3 × ULN may be eligible after communication with and approval from the medical monitor b. Transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) ≤3 × ULN (or ≤5.0 × ULN, if liver metastases) c. Alkaline phosphatase (ALP) ≤2.5 x ULN (or ≤5.0 x ULN, if liver or bone metastases) Note for patients with hepatic metastases who wish to enroll: If transaminase levels (AST and/or ALT) are >3 × but ≤5 × ULN, total bilirubin must be ≤1.5 × ULN. If total bilirubin is >1.5 × but ≤3 × ULN, both transaminases (AST and ALT) must be ≤3 × ULN.
7. Νεφρική λειτουργία: Κρεατινίνη ορού ≤1,5 × ΑΦΤ Ή, εάν η κρεατινίνη ορού > 1,5 × ΑΦΤ, υπολογιζόμενη κάθαρση κρεατινίνης ≥ 30 mL/min (με Cockcroft).
Bone marrow function: a. Hemoglobin ≥9.0 g/dL b. Absolute neutrophil count (ANC) ≥1.5 × 109/L c. Platelet count ≥100 × 109/L
Prothrombin time (PT) ≤1.5 × ULN (or international normalized ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN. See additional criteria for patients on chronic anticoagulation in the inclusion criteria section of the protocol.
Anticipated life expectancy > 12 weeks.
Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception methods for 6 months after the last dose of cemiplimab or cemiplimab and RP1 combination treatment. In addition, male patients must refrain from donating sperm during this study treatment and for up to 6 months after the last dose of cemiplimab or cemiplimab and RP1 combination treatment. For a definition of highly effective contraceptive methods and instructions of patients and partners, see Section 9.3.4.9
Locally advanced CSCC only (Surgery): Patients must be deemed as not appropriate candidates for curative surgery in the opinion of either a medical oncologist with experience in cutaneous malignancy management, a dermatologist, a head and neck surgeon, or a multidisciplinary disease management team, or documented to have refused surgery. See Section 4.2.1 of the protocol for definitions of acceptable contraindications for surgery.
Locally advanced CSCC only (Radiotherapy): Patients must be deemed as not appropriate candidates for curative radiation therapy as defined in the inclusion section of the protocol, or documented as having refused radiotherapy despite consultation. This must include either a radiation oncologist, a medical oncologist, a head and neck surgeon, a dermatologist with expertise in cutaneous malignancies, or a multidisciplinary team. See Section 4.2.1 of the protocol for definitions of acceptable contraindications for radiation therapy.
All patients must consent to provide archived (within 12 months [6 months preferred] of screening date) or newly obtained tumor material (either formalin-fixed, paraffin-embedded [FFPE] block or unstained slides) for central pathology review for confirmation of diagnosis of CSCC and biomarker analysis.
Tumor biopsies will be taken as specified in the Schedules of Events (Section 9.1).
Histologically confirmed diagnosis of locally advanced or metastatic (nodal or distant) CSCC by local pathology report. Metastatic (nodal or distant) disease is defined as disseminated disease distant to the initial/primary site of diagnosis. The locally recurrent disease is defined as previously treated disease (with either surgery, radiotherapy, or systemic therapy) and is not amenable to either curative surgery, radiotherapy, or concurrent chemoradiotherapy treatment.
At least one measurable lesion and lesion(s) that are injectable, which individually or in aggregate meet the measurable criteria. There is no minimum tumor size for injection, provided there are injectable tumors that are in aggregate ≥1 cm at baseline. Note on measurable lesions: A lesion in an area that has received prior locoregional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression in the lesion since the therapy as defined by RECIST 1.1 (Appendix 1) or clinical assessment criteria (Appendix 2). Note on Metastatic (nodal or distant) CSCC: Measurable lesions are lesions ≥1.0 cm in their longest diameter (≥1.5 cm shortest diameter for lymph nodes) according to RECIST 1.1. Patients with metastatic disease that does not meet target lesion criteria by RECIST 1.1 (eg, bone only lesions, perineural disease) and with externally visible CSCC target lesion(s) may be enrolled if they have at least 1 measurable externally visible lesion ≥1.0 cm in both perpendicular diameters at baseline. Composite response criteria (Appendix 2) should be used to evaluate patients who have both externally visible target lesion(s) that are evaluable by clinical response criteria (Appendix 2) and non-measurable lesions by RECIST 1.1 (Appendix 1) that are being followed radiologically as non-target lesions. Note on locally advanced CSCC: Measurable lesions are lesions ≥1.0 cm in both perpendicular diameters that are being evaluated by clinical response criteria (Appendix 2).

What rules you out

Prior treatment with an oncolytic therapy.
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for ImAEs or a diagnosis of immunodeficiency disorders (such as human immunodeficiency virus [HIV] disease or organ transplantation or hematologic malignancies associated with immune suppression). Note: The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, alopecia areata or psoriasis that does not require systemic treatment.
Prior treatment with an agent that blocks the programmed cell death-1 (receptor) (PD-1)/PD-L1 pathway
Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years. Examples of immune modulating agents include therapeutic anticancer vaccines, cytokine treatments (other than granulocyte colony-stimulating factor [G-CSF] or erythropoietin), or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), PI 3-K-delta, or OX-40.
Untreated brain metastasis(es) that are considered active. See exclusion criteria in the protocol for exceptions for brain metastases (Section 4.2.2).
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to randomization/enrollment. See exclusion criteria in protocol for exceptions for corticosteroids (Section 4.2.2).
Patient who has acute or chronic active hepatitis B or known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C virus (defined as HCV RNA [qualitative] or HIV infection. Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.
History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
Patients with allergy or hypersensitivity to RP1’s or cemiplimab’s excipients must be excluded.
Female who has a positive serum β-hCG pregnancy (at screening within 72 hours before dosing) and urine pregnancy test (Cycle 1 Day1) or is breast feeding or planning to become pregnant.
Concurrent malignancy other than CSCC and/or history of malignancy other than CSCC within 3 years of date of first planned dose of cemiplimab, except for tumors with negligible risk of metastasis or death. Examples are provided in Section 4.2.2.
Active infection requiring systemic therapy within 14 days prior to randomization/enrollment.
Any acute or chronic psychiatric problems or substance abuse disorders that, in the opinion of the investigator, would interfere with the patient cooperating with the requirements of the study.
Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the investigator, renders the patient unsuitable for participation in a clinical trial due to high safety risks and/or potential to affect interpretation of results of the study.
Inability to undergo any contrast-enhanced radiologic response assessment (except as outlined in the protocol eligibility exclusion section [Section 4.2.2]).
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization/enrollment. See exclusion criteria in the protocol for exceptions (Section 4.2.2).
History of interstitial lung disease (ILD)/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
History of myocarditis or congestive heart failure (as defined by the New York Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection or myocardial infarction within 6 months of randomization.
Grade ≥3 hypercalcemia at time of enrollme
Any systemic anticancer treatment (chemotherapy, targeted systemic therapy, or photodynamic therapy), investigational or standard of care, within 28 days of randomization/enrollment or planned to occur during the study period (patients receiving bisphosphonates or denosumab are not excluded). Radiation therapy within 14 days of randomization/enrollment or planned to occur during the study period. Any major surgical procedure ≤28 days before randomization. Patients must have recovered adequately from the toxicity and/or complications from prior interventions prior to randomization/enrollment.
Was administered a live vaccine ≤28 days before randomization. Note: Seasonal vaccines for influenza or SARS-CoV-2 are generally inactivated vaccines and are allowed (Please see Section 8.1 for additional guidance). Vaccines that are live/attenuated vaccines (such as the intranasal influenza vaccine) are not allowed
Patients with active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis, encephalitis, or disseminated herpes infection). Note: patients with sporadic cold sores l may be enrolled as long as no active cold sores are present at the time of randomization/enrollment. See Section 5.5 for further guidance
Patients who require intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).

The study team makes the final eligibility decision.

Where it's taking place

Australia
Canada
United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Australia; Canada; United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.