Clinical trial · Interventional
Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx
NCT05551767CI-TRIAL-00061024unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neck Cancer | Malignant Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.
- interventionNames
- Drug: Pembrolizumab
Primary outcomes (2)
- measure
- complete response rate
- timeFrame
- through study completion, an average of 3 years
- description
- rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy
- measure
- progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification; * Tumor is morphlogically confirmed; * CPS\>1 (22C3 clone); * ECOG 0-2; * Age above 18 years; * Signed Informed consent form. Exclusion Criteria: * Cancer of nasopharynx; * Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer; * Stages I or II; * ECOG\>=3.
References
Publications (0)
Data not yet available
No reference posted for this study.