Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab

NCT05075122 | Unknown Phase 2 DMC

• 2 other identifiers: KKSH1762020-005910-17
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS \>=1) head and neck squamous cell carcinoma. Secondary objectives are to determine the efficacy in terms of overall survival ,objective response rate and duration of response. 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate

  according to iRECIST

  6 months after first administration of study medication

Secondary Outcomes (7)

• Progression free survival

  every three months, until progression of disease, maximum 12 months from the date of LPI (last patient in)

• Overall survival

  every three months, until death, maximum 12 months from the date of LPI (last patient in)

• Objective Response Rate

  every three months, until death, maximum 12 months from the date of LPI (last patient in)

• Duration of Response

  every three months, until death, maximum 12 months from the date of LPI (last patient in)

• Rate of immune responses against hTERT peptides

  Baseline, up to 8 weeks, time of progression (max. 12 months after LPI)

Study Arms (2)

Vaccination arm

EXPERIMENTAL

Pembrolizumab flat dose iv every 3 weeks + UV1 vaccination (UV1 plus GM-CSF/Sargramostim as adjuvant per vaccination)

Biological: UV1; Drug: Sargramostim for Injection; Drug: Pembrolizumab injection

Calibration arm

OTHER

Pembrolizumab flat dose iv every 3 weeks

Drug: Pembrolizumab injection

Interventions

UV1 BIOLOGICAL

UV1 vaccination (300 μg) UV1 vaccination will be applied in a dense schedule with three vaccinations during one week before initiation of pembrolizumab, followed by 5 additional vaccinations every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14)

Vaccination arm

Sargramostim for Injection DRUG

75 μg GM-CSF as adjuvant per vaccination. Applied in a dense schedule with three injections during one week before initiation of pembrolizumab, followed by 5 additional injections every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14).

Vaccination arm

Pembrolizumab injection DRUG

200mg flat dose iv every 3 weeks. Pembrolizumab will be administered beyond the EOT visit at physician discretion until disease progression and up to a maximum of two years (standard of care)

Calibration arm; Vaccination arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of a non-resectable recurrent or metastatic head and neck squamous cell carcinoma (not necessarily reconfirmed at time of enrolment)
• 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.

You may not qualify if:

• Patients for whom a combination therapy of a checkpoint inhibitor and a chemotherapy is deemed necessary in the opinion of the investigator
• Active, known, or suspected autoimmune disease requiring systemic treatment.
• A 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, in the opinion of the investigator, 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 than 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.
• 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 human granulocyte-macrophage colony stimulating factor, yeast-derived products or any constituent of the products
• Receipt of a live vaccine within 30 days prior to start of therapy
• Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
• Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical study and therefore cannot form a rational intention in the light of the facts.

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead
• Ultimovacs ASA: collaborator
• Apotheke der Universitätsmedizin der Johannes Gutenberg-Universität Mainz (Germany): collaborator
• Axel Hinke. CCRC Cancer Clinical Research Consulting (Düsseldorf, Germany: collaborator

Study Sites (10)

Universitätsklinikum Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie

Aachen, Germany

NOT YET RECRUITING

Charité Universitätsmedizin, Comprehensive Cancer Center, Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie

Berlin, Germany

NOT YET RECRUITING

Universitätsklinikum Greifswald, Klinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie

Greifswald, Germany

NOT YET RECRUITING

Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin IV

Halle, Germany

RECRUITING

Universitätsklinikum Hamburg, Universitäres Cancer Center Hamburg UCCH, Hubertus Wald Tumorzentrum

Hamburg, Germany

NOT YET RECRUITING

Klinikum St. Georg gGmbH

Leipzig, Germany

NOT YET RECRUITING

Universitätsklinikum Leipzig, Klinik und Poliklinik für HNO Heilkunde

Leipzig, Germany

RECRUITING

Universitätsklinikum Mainz, III. Medizinische Klinik und Poliklinik

Mainz, Germany

RECRUITING

Klinikum Stuttgart, Klinik für Hämatologie, Onkologie und Palliativmedizin

Stuttgart, Germany

RECRUITING

Universitätsklinikum Würzburg, Comprehensive Cancer Center Mainfranken

Würzburg, Germany

NOT YET RECRUITING

Related Publications (3)

• Paschold L, Schultheiss C, Schmidt-Barbo P, Klinghammer K, Hahn D, Tometten M, Schafhausen P, Blaurock M, Brandt A, Westgaard I, Kowoll S, Stein A, Hinke A, Binder M. Inflammation and limited adaptive immunity predict worse outcomes on immunotherapy in head and neck cancer. NPJ Precis Oncol. 2025 Aug 5;9(1):272. doi: 10.1038/s41698-025-01020-6.

  PMID: 40764401 DERIVED

• Brandt A, Klinghammer K, Schultheiss C, Paschold L, Wickenhauser C, Bauer M, Bergqvist A, Hahn D, Schafhausen P, Tometten M, Blaurock M, Zech HB, Busch CJ, Dietz A, Muller-Richter U, Alt J, Boehm A, Kowoll S, Steighardt J, Lasch A, Westgaard IH, Westhrin M, Stein A, Hinke A, Binder M. UV1 vaccination in pembrolizumab-treated patients with recurrent or metastatic head and neck cancer: A randomized multicenter phase 2 trial. Med. 2025 Jul 11;6(7):100647. doi: 10.1016/j.medj.2025.100647. Epub 2025 Apr 11.

  PMID: 40220758 DERIVED

• Brandt A, Schultheiss C, Klinghammer K, Schafhausen P, Busch CJ, Blaurock M, Hinke A, Tometten M, Dietz A, Muller-Richter U, Hahn D, Alt J, Stein A, Binder M. Tolerability and efficacy of the cancer vaccine UV1 in patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab - the randomized phase 2 FOCUS trial. Front Oncol. 2024 Feb 7;14:1283266. doi: 10.3389/fonc.2024.1283266. eCollection 2024.

  PMID: 38384801 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

sargramostim; Injections; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mascha Binder, MD

  University Medical Center Halle, Department of Hematology and Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mascha Binder, MD

CONTACT

0049 345 557; mascha.binder@uk-halle.de

Christine Dierks, MD

CONTACT

0049 345 557; christine.dierks@uk-halle.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: October 12, 2021
• Study Start: August 2, 2021
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

DE (10)