Clinical trial • Phase II • Oncology

Lenvatinib for Locally advanced head and neck squamous cell carcinoma

Phase II trial of Lenvatinib for Locally advanced head and neck squamous cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced head and neck squamous cell carcinoma
Trial Stage
Phase II
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
06-09-2024
First CTIS Authorization Date
18-09-2024

Trial design

Pembrolizumab alone (KEYTRUDA 25 mg/mL concentrate for solution for infusion) as comparator arm; experimental arm is pembrolizumab plus lenvatinib (LENVIMA 10 mg hard capsules). Specific doses and schedules are not specified in the CTIS record.-controlled Phase II trial across 10 sites in Germany.

Comparator
Pembrolizumab alone (KEYTRUDA 25 mg/mL concentrate for solution for infusion) as comparator arm; experimental arm is pembrolizumab plus lenvatinib (LENVIMA 10 mg hard capsules). Specific doses and schedules are not specified in the CTIS record.
Target Sample Size
50

Eligibility

Recruits 50 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is required via the subject information and informed consent form document (L1_PeLeRad_SIS_ICF_redacted) for adult participants. No explicit assent/parental consent procedures or vulnerable-population consent details are provided in the available CTIS data..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is required via the subject information and informed consent form document (L1_PeLeRad_SIS_ICF_redacted) for adult participants. No explicit assent/parental consent procedures or vulnerable-population consent details are provided in the available CTIS data.

Inclusion criteria

  • {"criterion_text":"- Locally advanced HNSCC stage III-IVB (TNM version 8)\n- histological confirmation\n- Baseline PD-L1 CPS≥1 (before radiochemotherapy)\n- Completed definitive radiochemotherapy (radiation dose ≥68Gy, with at least 200mg/m² BSA Cisplatin)\n- No progression during radiochemotherapy\n- ECOG PS 0 or 1"}

Exclusion criteria

  • {"criterion_text":"- prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)\n- uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication\n- distant metastases\n- tumor infiltration/perforation of the skin or cervical fistula (either at timepoint of study inclusion or prior to RCT)\n- known additional malignancy that is progressing or have required active treatment within the past 3 years"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event-free survival (EFS) rate at 2 years: The disease progression will be evaluated radiologically (according to RECIST 1.1 criteria, investigator assessed). Death due to any case is an event. In addition, this endpoint will count salvage surgery at any time point for persistent or residual tumor as event if cancer is present in the pathological assessment. Further, neck dissection >20 weeks from the end of RCT will be an event if cancer is present in the pathological assessment","definition_or_measurement_approach":"Disease progression evaluated radiologically according to RECIST 1.1 (investigator assessed). Death considered an event. Salvage surgery counted as an event if pathology shows cancer. Neck dissection >20 weeks from end of radiochemotherapy counted as event if pathology shows cancer."}

Recruitment

Planned Sample Size
50
Recruitment Window Months
13
Consent Approach
Informed consent to be obtained using the subject information and informed consent form (document: L1_PeLeRad_SIS_ICF_redacted). Consent expected to be provided by adult participants; no age-specific consent/assent procedures or languages are specified in the CTIS data.

Geography

Total Number Of Sites
10
Total Number Of Participants
50

Germany

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
18-09-2024
Processing Time Days
16
Number Of Sites
10
Number Of Participants
50

Sites

Site Name
Universitaetsklinikum Augsburg
Department Name
Klinik für Strahlentherapie
Contact Person Name
Klaus-Henning Kahl
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Hals-Nasen-Ohrenheilkunde und Kopfhalschirurgie
Contact Person Name
Simon Laban
Contact Person Email
Simon.Laban@uniklinik-ulm.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Strahlenklinik
Contact Person Name
Marlen Haderlein
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Klinik für Strahlentherapie und Onkologie
Contact Person Name
Maximilian Fleischmann
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Klinik für Hals-Nasen-Ohrenheilkunde
Contact Person Name
Christine Langer
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Strahlentherapie und Radioonkologie
Contact Person Name
Bálint Tamaskovics
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Strahlentherapie
Contact Person Name
Christoph Suess
Contact Person Email
c.suess@ukr.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Radioonkologie
Contact Person Name
Gunther Klautke
Contact Person Email
G.Klautke@skc.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
Gemeinschaftspraxis Hämatologie – Onkologie, Freiberg-Richter, Jacobasch, Illmer, Wolf
Contact Person Name
Thomas Illmer
Contact Person Email
buero@onkologie-dresden.net
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Strahlentherapie und Radioonkologie
Principal Investigator Name
Markus Hecht
Principal Investigator Email
Markus.Hecht.Clinicaltrials@uks.eu
Contact Person Name
Markus Hecht

Sponsor

Primary sponsor

Full Name
Universitaet Des Saarlandes
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Third parties

  • {"country":"Germany","full_name":"Interdisziplinaeres Zentrum Klinische Studien (IZKS)","duties_or_roles":"Unspecified (sponsorDuties code 8)","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
LENVIMA 10 mg hard capsules
Active Substance
Lenvatinib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (EU marketing authorisation EU/1/15/1002/002)
Maximum Dose
20 mg (max daily dose amount: 20 mg)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (EU marketing authorisation EU/1/15/1024/002)
Maximum Dose
200 mg (max daily dose amount: 200 mg)
Combination Treatment
Yes

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