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Clinical trial of V940 and pembrolizumab in people with resectable locally advanced cutaneous squamous cell carcinoma
EU CTIS ID: 2023-505712-37-00
What this study is testing
To evaluate V940 plus pembrolizumab, SOC and pembrolizumab monotherapy with respect to EFS as assessed by investigator.
- Phase II and Phase III (Integrated)
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
- Has a histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization.
- Has adequate organ function.
- If hepatitis B surface antigen (HBsAg) positive must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- If there is a history of hepatitis C virus (HCV) infection HCV viral load must be undetectable at screening.
- If human Immunodeficiency Virus (HIV)-infected must have well controlled HIV on antiretroviral therapy (ART).
You likely can't join if
- Has any other histologic type of skin cancer other than invasive cSCC as well as mixed histology, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), or melanoma.
- 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 (in dosing exceeding 10 mg daily of prednisone equivalent) or 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.
- History of chronic lymphocytic leukemia (CLL).
- History of central nervous system (CNS) metastases and/or carcinomatous meningitis.
See the full eligibility criteria
Who can join
- Has a histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization.
- Has adequate organ function.
- If hepatitis B surface antigen (HBsAg) positive must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- If there is a history of hepatitis C virus (HCV) infection HCV viral load must be undetectable at screening.
- If human Immunodeficiency Virus (HIV)-infected must have 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 or is able to provide one that is suitable for the Next-generation Sequencing (NGS) required for this study.
- 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 intismeran autogene: 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.
What rules you out
- Has any other histologic type of skin cancer other than invasive cSCC as well as mixed histology, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), or melanoma.
- 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 (in dosing exceeding 10 mg daily of prednisone equivalent) or 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.
- History of chronic lymphocytic leukemia (CLL).
- History of central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (≥Grade 3) to either intismeran autogene or pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has active infection requiring systemic therapy.
- Has HIV with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Has distant metastatic disease (M1), visceral and/or distant nodal.
- Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection
- Has had a myocardial infarction within 6 months of randomization.
- History of allogeneic tissue/solid organ transplant.
- Has 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.
- Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the screening blood sample (including the NGS blood sample).
- Has received prior treatment with another cancer vaccine.
- Has received prior radiotherapy to the index lesion (in-field lesion). Must have recovered from all radiation-related toxicities prior to randomization and not have had radiation pneumonitis.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Chile
- New Zealand
- Israel
- Canada
- United States
- Turkey
- Brazil
- Colombia
- Argentina
- Australia
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 United Kingdom; Chile; New Zealand; Israel; Canada; United States and 5 more location(s). 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.