Clinical trial of V940 and pembrolizumab in people with resectable locally advanced cutaneous squamous cell carcinoma
- Conditions
- Therapeutic area: Diseases [C] - Neoplasms [C04]The participants must have a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).MedDRA version: 24.1Level: LLTClassification code: 10085908Term: Cutaneous squamous cell carcinoma Class: 100000004848
- Registration Number
- CTIS2023-505712-37-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 607
Has a histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) (cSCC that is amenable to achieve complete oncologic resection (R0 or R1) and is not expected to result in permanent significant functional loss or severe disfigurement) as the primary site of malignancy., Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization., Has adequate organ function., Hepatitis B surface antigen (HBsAg) positive participants are considered eligible if received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization., Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening., Human Immunodeficiency Virus (HIV)-infected participants has well controlled HIV on antiretroviral therapy (ART)., Has locally advanced (LA) Stage II-IV (M0) cSCC without distant metastases., cSCC is amenable to surgery (resectable) with curative intent., Has a formalin-fixed, paraffin-embedded (FFPE) tumor sample available that is suitable for the Next-generation Sequencing (NGS) required for this study. The sample should meet the protocol defined criteria., Is an individual of any sex/gender and at least 18 years of age., For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving adjuvant radiation therapy (RT), and for =3 months after the last dose of study intervention., Is female and not pregnant/breastfeeding and at least one of the following applies during the study : is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) at least during use of V940: 15 days, Pembrolizumab: 120 days, Adjuvant RT, if performed: 90 days after last exposure or is a WOCBP who is abstinent from heterosexual intercourse., Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology., Has a life expectancy of >3 months per investigator assessment.
Has any other histologic type of skin cancer other than invasive cSCC as well as mixed histology., Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration., Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy any other form of immunosuppressive therapy within 7 days prior the first dose of study medication., Has known additional malignancy that is progressing or has required active treatment within the past 2 years., Has history of chronic lymphocytic leukemia (CLL)., Has history of central nervous system (CNS) metastases and/or carcinomatous meningitis., Has active autoimmune disease that has required systemic treatment in the past 2 years., Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Has active infection requiring systemic therapy., HIV-infected participant has history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Has concurrent active Hepatitis B and Hepatitis C virus infection., Has distant metastatic disease (M1), visceral and/or distant nodal., Has myocardial infarction within 6 months of randomization., Has history of allogeneic tissue/solid organ transplant., Participants who have not adequately recovered from major surgery or have ongoing surgical complications., Has received prior therapy with an anti-programmed cell death receptor 1 (anti-PD-1), anti-programmed cell death receptor ligand 1 (anti-PD-L1), or anti-programmed cell death receptor ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte associated protein 4 (CTLA-4), OX-40, CD137)., Has received prior systemic anticancer therapy including investigational agents for cSCC before randomization., Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids., Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed., Has received transfusion of blood products., Has received prior treatment with another cancer vaccine., Has received prior radiotherapy to the index lesion (in-field lesion).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method