A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)
- Conditions
- Carcinoma, Squamous CellSkin Neoplasms
- Registration Number
- NCT06295809
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1012
Inclusion Criteria:<br><br> - Has a histologically confirmed diagnosis of resectable cSCC as the primary site of<br> malignancy (metastatic skin involvement from another primary cancer or from an<br> unknown primary cancer is not permitted)<br><br> - Has LA Stage II-IV (M0) cSCC without distant metastases<br><br> - cSCC must be amenable to surgery (resectable) with curative intent<br><br> - Has a formalin-fixed, paraffin-embedded (FFPE) tumor sample available or is able to<br> provide one that is suitable for the Next-generation Sequencing (NGS) required for<br> this study<br><br> - For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a<br> highly effective contraceptive method while receiving adjuvant radiation therapy<br> (RT), and for =3 months after the last dose of study intervention<br><br> - Is female and not pregnant/breastfeeding and at least one of the following applies<br> during the study : is not a woman of childbearing potential (WOCBP), is a WOCBP and<br> uses highly effective contraception (low user dependency method OR a user dependent<br> hormonal method in combination with a barrier method) at least during use of V940:<br> 15 days, Pembrolizumab: 120 days, Adjuvant RT, if performed: 90 days after last<br> exposure or is a WOCBP who is abstinent from heterosexual intercourse<br><br> - Has measurable disease per RECIST 1.1 as assessed by the local site<br> investigator/radiology<br><br> - Has a life expectancy of >3 months per investigator assessment<br><br> - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1<br> assessed within 14 days before randomization<br><br> - Has adequate organ function<br><br> - If hepatitis B surface antigen (HBsAg) positive must have received hepatitis B virus<br> (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load<br> prior to randomization<br><br> - If there is a history of hepatitis C virus (HCV) infection, HCV viral load must be<br> undetectable at screening<br><br> - If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on<br> antiretroviral therapy (ART)<br><br>Exclusion Criteria:<br><br> - Has any other histologic type of skin cancer other than invasive cSCC as well as<br> mixed histology, eg, basal cell carcinoma that has not been definitively treated<br> with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), or melanoma<br><br> - Has distant metastatic disease (M1), visceral and/or distant nodal<br><br> - Has received prior therapy with an anti-programmed cell death receptor 1<br> (anti-PD-1), anti-programmed cell death receptor ligand 1 (anti-PD-L1), or<br> anti-programmed cell death receptor ligand 2 (anti-PD-L2) agent, or with an agent<br> directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic<br> T-lymphocyte associated protein 4 (CTLA-4), OX-40, CD137)<br><br> - Has received prior systemic anticancer therapy including investigational agents for<br> cSCC before randomization<br><br> - Has received prior radiotherapy within 2 weeks of start of study intervention, or<br> has radiation-related toxicities, requiring corticosteroids<br><br> - Has received a live or live-attenuated vaccine within 30 days before the first dose<br> of study intervention<br><br> - Has received transfusion of blood products (including platelets or red blood cells)<br> or administration of colony stimulating factors (including granulocyte<br> colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or<br> recombinant erythropoietin) within 2 weeks of the screening blood sample (including<br> the NGS blood sample)<br><br> - Has received prior treatment with another cancer vaccine<br><br> - Has received prior radiotherapy to the index lesion (in-field lesion). Must have<br> recovered from all radiation-related toxicities prior to randomization and not have<br> had radiation pneumonitis<br><br> - Has received an investigational agent or has used an investigational device within 4<br> weeks prior to study intervention administration<br><br> - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy<br> (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of<br> immunosuppressive therapy within 7 days prior the first dose of study medication<br><br> - Has a known additional malignancy that is progressing or has required active<br> treatment within the past 2 years<br><br> - History of chronic lymphocytic leukemia (CLL)<br><br> - History of central nervous system (CNS) metastases and/or carcinomatous meningitis<br><br> - Has severe hypersensitivity (=Grade 3) to either V940 or pembrolizumab and/or any of<br> its excipients<br><br> - Has an active autoimmune disease that has required systemic treatment in the past 2<br> years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)<br> is allowed<br><br> - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required<br> steroids or has current pneumonitis/interstitial lung disease<br><br> - Has an active infection requiring systemic therapy<br><br> - Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease<br><br> - Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV<br> DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA)<br> infection<br><br> - Has had a myocardial infarction within 6 months of randomization<br><br> - Has a history of allogeneic tissue/solid organ transplant<br><br> - Has not adequately recovered from major surgery or have ongoing surgical<br> complications
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event Free Survival (EFS)
- Secondary Outcome Measures
Name Time Method Overall response rate (ORR);Freedom from surgery (FFS) rate;Pathological complete response (pCR) rate;Major pathological response (mPR) rate;Disease-free survival (DFS);Disease-specific survival (DSS);Overall Survival (OS);Percentage of participants who experience and adverse event (AE);Percentage of participants who discontinue study intervention due to AEs;Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30);Change from baseline in physical functioning score of QLQ (C30 Items 1-5);Change from baseline in Role functioning score of QLQ-C30 Items 6-7