Recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: UV-1
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Not available
CAS Number: 1331848-79-3
Other descriptive name: P719-20
Concentration unit: mg milligram(s
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males and Females at least 18 years of age - Histologically confirmed diagnosis of a non-resectable recurrent or metastatic head and neck squamous cell carcinoma - At least one measurable tumor lesion as per RECIST v1.1, (Scan not older than 4 weeks before randomization) - Eligible for pembrolizumab monotherapy (PD-L1 CPS >/= 1%) and adequate laboratory parameters for pembrolizumab monotherapy as assessed by the investigator - ECOG-performance score 0-2 - Written informed consent obtained according to international guidelines and local laws - Ability to understand and give informed consent. - Safe contraception measures for males and females. Procedures with a pearl index of less than 1% apply as safe pregnancy prevention measures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Patients for whom a combination therapy of a checkpoint inhibitor and a chemotherapy is deemed necessary in the opinion of the investigator - Participation in another interventional study simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed) - Concurrent malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome - Active, known, or suspected autoimmune disease requiring systemic treatment - Concomitant therapy with systemic immune suppression (use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed; patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible) - History of severe autoimmune disorder or history of organ transplant - Any serious or uncontrolled medical disorder or active infection that may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug. - Significant acute or chronic infections including, among others (test not older tan 4 weeks prior to randomization): Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. - Intake of drug products which potentially cause adverse interactions with the medicinal product under investigation - Diseases/medical findings which may have a significant effect on the target variables and thus mask or inhibit the therapeutic effect under investigation - Pregnancy or lactation - (Bacterial) infections requiring systemic antibiotic treatment within 2 weeks prior to first dose of study treatment (depending on group assignment: either prior to first UV1 or prior to first pembrolizumab administration) - History of allergy or hypersensitivity to study drug or any constituent of the products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the clinical performance of the UV1 vaccine as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1%) head and neck squamous cell carcinoma in terms of progression free survival according to iRECIST (PFSR@6 months).;Secondary Objective: Secondary objectives are to determine the efficacy in terms of overall survival and objective response rate according to iRECIST. Further secondary objectives are the assessment of the rate of immune responses against hTERT peptides (as measured by 3H-Thymidine proliferation and IFNgamma ELISPOT assays) and the rate of clearance of ctDNA from blood on treatment. Another secondary objective is to investigate the Safety and tolerability of the UV1 vaccine in combination with pembrolizumab (acc. to NCI CTC AE v4.03 and to the obtained data on vital signs, clinical parameters and feasibility of the regimen). Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC.;Primary end point(s): Progression free survival rate at 6 months (PFSR@6) according to iRECIST;Timepoint(s) of evaluation of this end point: 6 months from study entry | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - progression free survival (PFS) - overall survival - objective response rate (ORR) according to iRECIST - duration of response - rate of immune responses against hTERT peptides (as measured by 3H-Thymidine proliferation and IFNgamma ELISPOT assays) - rate of clearance of ctDNA from blood on treatment - Safety and tolerability;Timepoint(s) of evaluation of this end point: - time point of tumor progression (PFS) - death of the patient (OS) - 6 months from study entry (ORR) - day 1, week 5, 8, 14, 30 days after last dose of study drug (ALD), 3 months ALD, 6 months ALD, at disease progression (rate of immune responses against hTERT peptides, rate of clearance of ctDNA from blood on treatment) - Until 30 days after last administration of study therapy (toxicity) | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Universitätsklinikum Halle
Outcome results
None listed