Actively Recruiting
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
Led by University of Leipzig · Updated on 2024-09-20
140
Participants Needed
9
Research Sites
345 weeks
Total Duration
On this page
Sponsors
U
University of Leipzig
Lead Sponsor
U
University of Göttingen
Collaborating Sponsor
AI-Summary
What this Trial Is About
ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \< 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.
CONDITIONS
Official Title
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with confirmed squamous cell carcinoma of the larynx or hypopharynx suitable for total laryngectomy
- Stage III, IVA or IVB disease with potential for clear resection margins and no extranodal extension of neck nodes
- Newly obtained excisional tumor biopsy with PD-L1 expression CPS 1 or higher
- Male participants agree to use contraception during treatment and for 120 days after last dose
- Female participants are not pregnant, not breastfeeding, and agree to contraception if of childbearing potential
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as defined by study protocol
You will not qualify if you...
- Positive pregnancy test within 72 hours before first dose in women of childbearing potential
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint agents
- Prior systemic anti-cancer therapy including investigational agents
- Prior radiotherapy
- Receipt of live or live-attenuated vaccine within 30 days before first dose
- Participation in another investigational study within 4 weeks before first dose
- Diagnosis of immunodeficiency or recent use of immunosuppressive therapy
- History of second malignancy unless treated and disease-free for 2 years
- Known distant metastases including active CNS metastases
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active Hepatitis B or C infection
- Known active tuberculosis
- Conditions or treatments interfering with study participation or safety
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnancy, breastfeeding, or planning to conceive/father children during study and 120 days after last dose
- History of allogenic tissue or organ transplant
- Known intolerance to substances used during treatment including antibiotics or antiemetics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Universitätsklinikum Mannheim, Klinik für Hals-Nasen-Ohrenheilkunde Theodor-Kutzer-Ufer 1-3
Mannheim, Baden-Würtemberg, Germany, 68167
Actively Recruiting
2
Universitätsklinikum Ulm / Ulm University Medical Center, Klinik für Hals- Nasen-Ohrenheilkunde und Kopf-Halschirurgie, Frauensteige 12
Ulm, Baden-Würtemberg, Germany, 89075
Actively Recruiting
3
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Ismaninger Straße 22
München, Bavaria, Germany, 81675
Not Yet Recruiting
4
Universität Regensburg, Klinik und Poliklinik für Strahlentherapie Franz-Josef-Strauss-Allee 11
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
5
Universitätsklinikum Würzburg, Klinik für Hals-, Nasen-, Ohrenheilkunde, Josef-Schneider-Straße 8
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
6
Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin, Charlottenstr. 72
Potsdam, Brandenburg, Germany, 14467
Not Yet Recruiting
7
Universitätsklinikum Köln, Klinik für Hals-, Nasen-, Ohrenheilkunde, Kerpener Str. 62
Cologne, North Rhine-Westphalia, Germany, 50937
Not Yet Recruiting
8
University of Leipzig, Department für Kopf- und Zahnmedizin, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Liebigstrasse 12
Leipzig, Saxon, Germany, 04103
Actively Recruiting
9
Universitätsklinikum Jena Klinik für Hals-, Nasen- und Ohrenheilkunde, Am Klinikum 1
Jena, Thuringia, Germany
Not Yet Recruiting
Research Team
A
Andreas Dietz, MD PhD
CONTACT
S
Susanne Wiegand, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here