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Treatment for advanced laryngeal and hypopharyngeal cancer using chemotherapy and immunotherapy

ELOS - Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiation Compared to Additional PD-1 Inhibition in CPS ≥1 Advanced Laryngeal/Hypopharyngeal Cancer Suitable for Laryngectomy Selected After Early Response Evaluation

Phase 2 Interventional University of Leipzig · NCT06137378

This study is testing if adding an immune therapy to chemotherapy can help people with advanced throat cancer keep their voice box while improving their chances of survival.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorUniversity of Leipzig Academic / other
Drugs / interventionspembrolizumab, prednisone, chemotherapy, radiation
Locations9 sites (Mannheim, Baden-Würtemberg and 8 other locations)
Trial IDNCT06137378 on ClinicalTrials.gov

What this trial studies

The ELOS trial is a phase II multicenter clinical trial designed to evaluate the effectiveness of induction chemotherapy combined with the immune checkpoint inhibitor pembrolizumab in patients with advanced squamous cell carcinoma of the larynx or hypopharynx. Participants will receive initial chemotherapy followed by an assessment of their tumor response, with those showing significant shrinkage continuing on pembrolizumab for additional treatment. The primary goal is to compare laryngectomy-free survival between patients receiving standard treatment and those receiving the additional immunotherapy. This study aims to preserve the larynx in patients who respond well to the initial treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage III or IV squamous cell carcinoma of the larynx or hypopharynx who have PD-L1 expression in their tumor tissue.

Not a fit: Patients with non-squamous cell carcinoma or those who do not express PD-L1 in their tumor tissue may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve larynx preservation and survival rates for patients with advanced head and neck cancers.

How similar studies have performed: Previous studies have shown promising results with similar combinations of chemotherapy and immunotherapy in head and neck cancers, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of the larynx or hypopharynx according to the decision of the multidisciplinary tumor board suitable for total laryngectomy can be enrolled in this study.
2. Stage III, IVA or IVB, whenever clear resection margins R0 \>5 mm can be achieved and no radiologic signs of extranodal extension of neck nodes are present.
3. Have provided newly obtained excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
4. PD-L1-expression\* within the tumor biopsy, CPS ≥1
5. Male participants:

   A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
6. Female participants:

   A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
   1. Not a woman of childbearing potential (WOCBP) OR
   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
8. Have adequate organ function as defined in the (Table 4) of the protocol. Specimens must be collected within 10 days prior to the start of study treatment.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
2. Has received 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 receptor on T or NK cells (e.g., CTLA-4, OX 40, CD137).
3. Has received prior systemic anti-cancer therapy including investigational agents.
4. Has received prior radiotherapy.
5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
9. Has known distant metastases including active CNS metastases and/or carcinomatous meningitis.
10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
12. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
13. Has an active infection requiring systemic therapy.
14. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.
15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
16. Has a known history of active TB (Bacillus Tuberculosis).
17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
20. Has had an allogenic tissue/solid organ transplant.
21. Has a known intolerance to one of the substances administered during treatment including e.g. antibiotics, antiemetics, etc. or any other component of concurrent auxiliary medication.

Where this trial is running

Mannheim, Baden-Würtemberg and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Squamous Cell Carcinoma of Head and NeckHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell Carcinoma Stage IIILaryngeal Squamous Cell Carcinoma Stage IVSquamous Cell Carcinoma of LarynxSquamous Cell Carcinoma of the LarynxSquamous Cell Carcinoma of the Larynx Stage IIISquamous Cell Carcinoma of the Larynx Stage IV
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.