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 (FOCUS)
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ClinicalTrials.gov Identifier: NCT05075122 |
Recruitment Status :
Recruiting
First Posted : October 12, 2021
Last Update Posted : March 9, 2022
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Condition or disease | Intervention/treatment | Phase |
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Head and Neck Squamous Cell Carcinoma | Biological: UV1 Drug: Sargramostim for Injection Drug: Pembrolizumab injection | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Multicenter Study Investigating the Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic PD-L1 Positive (CPS≥1) Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab |
Actual Study Start Date : | August 2, 2021 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Vaccination arm
Pembrolizumab flat dose iv every 3 weeks + UV1 vaccination (UV1 plus GM-CSF/Sargramostim as adjuvant per vaccination)
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Biological: UV1
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) Drug: Sargramostim for Injection 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). Drug: Pembrolizumab injection 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
Pembrolizumab flat dose iv every 3 weeks
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Drug: Pembrolizumab injection
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) |
- Progression free survival rate [ Time Frame: 6 months after first administration of study medication ]according to iRECIST
- Progression free survival [ Time Frame: every three months, until progression of disease, maximum 12 months from the date of LPI (last patient in) ]according to iRECIST
- Overall survival [ Time Frame: every three months, until death, maximum 12 months from the date of LPI (last patient in) ]
- Objective Response Rate [ Time Frame: every three months, until death, maximum 12 months from the date of LPI (last patient in) ]Complete Remission (CR) + Partial Remission (PR) according to iRECIST
- Duration of Response [ Time Frame: every three months, until death, maximum 12 months from the date of LPI (last patient in) ]according to iRECIST
- Rate of immune responses against hTERT peptides [ Time Frame: Baseline, up to 8 weeks, time of progression (max. 12 months after LPI) ]measured by 3H-Thymidine proliferation and IFNgamma ELISPOT assays
- Rate of clearance of ctDNA from blood on treatment [ Time Frame: Baseline, week 5, week 8 and 1, 3, 6 months after EOT (max. 14 weeks), time of progression (max. 12 months after LPI) ]
- Adverse Events [ Time Frame: 3 months after EOT (maximum 25 weeks after start of treatment) ]according to NCI CTC AE v5.0
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075122
Contact: Mascha Binder, MD | 0049 345 557 ext 2054 | mascha.binder@uk-halle.de | |
Contact: Christine Dierks, MD | 0049 345 557 ext 2590 | christine.dierks@uk-halle.de |
Germany | |
Universitätsklinikum Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie | Not yet recruiting |
Aachen, Germany | |
Charité Universitätsmedizin, Comprehensive Cancer Center, Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie | Not yet recruiting |
Berlin, Germany | |
Universitätsklinikum Greifswald, Klinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie | Not yet recruiting |
Greifswald, Germany | |
Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Innere Medizin IV | Recruiting |
Halle (Saale), Germany | |
Universitätsklinikum Hamburg, Universitäres Cancer Center Hamburg UCCH, Hubertus Wald Tumorzentrum | Not yet recruiting |
Hamburg, Germany | |
Klinikum St. Georg gGmbH | Not yet recruiting |
Leipzig, Germany | |
Universitätsklinikum Leipzig, Klinik und Poliklinik für HNO Heilkunde | Recruiting |
Leipzig, Germany | |
Universitätsklinikum Mainz, III. Medizinische Klinik und Poliklinik | Recruiting |
Mainz, Germany | |
Klinikum Stuttgart, Klinik für Hämatologie, Onkologie und Palliativmedizin | Recruiting |
Stuttgart, Germany | |
Universitätsklinikum Würzburg, Comprehensive Cancer Center Mainfranken | Not yet recruiting |
Würzburg, Germany |
Principal Investigator: | Mascha Binder, MD | University Medical Center Halle, Department of Hematology and Oncology |
Responsible Party: | Mascha Binder, MD, Prof. Dr. med., Martin-Luther-Universität Halle-Wittenberg |
ClinicalTrials.gov Identifier: | NCT05075122 |
Other Study ID Numbers: |
KKSH176 2020-005910-17 ( EudraCT Number ) |
First Posted: | October 12, 2021 Key Record Dates |
Last Update Posted: | March 9, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site |
Pembrolizumab Sargramostim Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |