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Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC

NCT07026474 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-03-02

No results posted yet for this study

Summary

Prospective, open-label, randomized controlled phase III trail that aims to investigate whether Re-Radiochemotherapy (Re-RCT) and sequential immunotherapy with pembrolizumab improves overall survival compared to the standard treatment with pembrolizumab alone (± chemotherapy) in locoregionally recurrent PD-L1 positive (CPS≥1) HNSCC.

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

cisplatin + 5-fluorouracil (5FU)

Cisplatin: 100mg/m² BSA d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w

OTHER

radiotherapy

single doses of 1.8Gy up to a total dose of 55.8Gy to 63.0Gy

DRUG

Cisplatin

40mg/m² BSA weekly concomitant to re-irradiation

DRUG

Pembrolizumab

i.v., 200mg absolute, q3w

DRUG

Alternative medications: carboplatin + 5-fluorouracil (5FU)

Carboplatin: AUC5 d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w

DRUG

Alternative medications: carboplatin

AUC2 weekly

DRUG

Pembrolizumab

i.v., 200mg absolute, q3w, starting within 8-14 days after completion of RCT

Sponsors & Collaborators

  • Universität des Saarlandes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2032-12-31
Completion
2032-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026474 on ClinicalTrials.gov