Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
50
Countries
1
Sites
10
Locally advanced head and neck squamous cell carcinoma
To study efficacy of pembrolizumab/lenvatinib maintenance therapy versus pembrolizumab alone after definitive radiochemotherapy of locally advanced HNSCC to prolong the event-free survival (EFS) rate at 2 years.
Key facts
- Sponsor
- Universitaet Des Saarlandes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 May 2023 → ongoing
- Decision date (initial)
- 2024-09-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516536-10-00
- EudraCT number
- 2021-004388-28
- ClinicalTrials.gov
- NCT05433116
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To study efficacy of pembrolizumab/lenvatinib maintenance therapy versus pembrolizumab alone after definitive radiochemotherapy of locally advanced HNSCC to prolong the event-free survival (EFS) rate at 2 years.
Conditions and MedDRA coding
Locally advanced head and neck squamous cell carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10041857 | Squamous cell carcinoma of the oral cavity | 100000004864 |
| 21.1 | PT | 10031112 | Oropharyngeal squamous cell carcinoma | 100000004864 |
| 27.0 | PT | 10041849 | Squamous cell carcinoma of the hypopharynx | 100000004864 |
| 26.1 | PT | 10023856 | Laryngeal squamous cell carcinoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Locally advanced HNSCC stage III-IVB (TNM version 8)
- histological confirmation
- Baseline PD-L1 CPS≥1 (before radiochemotherapy)
- Completed definitive radiochemotherapy (radiation dose ≥68Gy, with at least 200mg/m² BSA Cisplatin)
- No progression during radiochemotherapy
- ECOG PS 0 or 1
Exclusion criteria 5
- 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)
- uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication
- distant metastases
- tumor infiltration/perforation of the skin or cervical fistula (either at timepoint of study inclusion or prior to RCT)
- known additional malignancy that is progressing or have required active treatment within the past 3 years
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 3400 mg milligram(s)
- Max treatment duration
- 47 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2958374 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 6720 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EX08 — -
- Marketing authorisation
- EU/1/15/1002/002
- MA holder
- EISAI GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaet Des Saarlandes
- Sponsor organisation
- Universitaet Des Saarlandes
- Address
- Kirrberger Strasse 100
- City
- Homburg
- Postcode
- 66421
- Country
- Germany
Scientific contact point
- Organisation
- Universitaet Des Saarlandes
- Contact name
- Prof. Dr. Markus Hecht
Public contact point
- Organisation
- Universitaet Des Saarlandes
- Contact name
- Prof. Dr. Markus Hecht
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Interdisziplinaeres Zentrum Klinische Studien (IZKS) ORG-100029409
|
Mainz, Germany | Code 8 |
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 50 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaet Des Saarlandes
Klinik für Strahlentherapie und Radioonkologie, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Ulm AöR
Klinik für Hals-Nasen-Ohrenheilkunde und Kopfhalschirurgie, Frauensteige 12, Mitte, Ulm
Gemeinschaftspraxis Haematologie Onkologie
Gemeinschaftspraxis Hämatologie – Onkologie, Freiberg-Richter, Jacobasch, Illmer, Wolf, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Universitaetsklinikum Erlangen AöR
Strahlenklinik, Universitaetsstrasse 27, Innenstadt, Erlangen
Universitaetsklinikum Duesseldorf AöR
Klinik für Strahlentherapie und Radioonkologie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Frankfurt AöR
Klinik für Strahlentherapie und Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Klinikum Chemnitz gGmbH
Klinik für Radioonkologie, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Augsburg
Klinik für Strahlentherapie, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Strahlentherapie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Giessen und Marburg GmbH
Klinik für Hals-Nasen-Ohrenheilkunde, Klinikstrasse 33, 35392, Giessen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-05-25 | 2023-06-01 | 2025-04-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PeLeRad_Protocol_2024-516536-10-00_redacted | 1.4 |
| Recruitment arrangements (for publication) | PeLeRad_CTIS_placeholder_doc_for_transitional_trials | 1 |
| Subject information and informed consent form (for publication) | L1_PeLeRad_SIS_ICF_redacted | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_KEYTRUDA 25 mg_ml Konz_Dec-2023 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lenvima_Nov-2023 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Germany | Acceptable 2024-09-16
|
2024-09-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-06 | Germany | Acceptable 2024-09-16
|
2025-10-06 |