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

ConditionRecurrent Head and Neck Squamous Cell Carcinoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversität des Saarlandes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained from the subject prior to performing any protocol-related procedures.

Age ≥ 18 years at time of study entry.

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Locoregionally recurrent or second primary HNSCC.

Disqualifiers

Prior radio(chemo)therapy of the neck less than 6 months ago.

Distant metastases (cM1).

Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 4 weeks of the first dose of treatment.

Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)

Trial design

Design model

Parallel

Treatments tested in this trial

radiotherapy
Other intervention
single doses of 1.8Gy up to a total dose of 55.8Gy to 63.0Gy
Cisplatin
Drug
40mg/m² BSA weekly concomitant to re-irradiation
Pembrolizumab
Drug
i.v., 200mg absolute, q3w
cisplatin + 5-fluorouracil (5FU)
Drug
Cisplatin: 100mg/m² BSA d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w
Alternative medications: carboplatin + 5-fluorouracil (5FU)
Drug
Carboplatin: AUC5 d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w
Alternative medications: carboplatin
Drug
AUC2 weekly
Pembrolizumab
Drug
i.v., 200mg absolute, q3w, starting within 8-14 days after completion of RCT

Treatment groups

214 Participants

are divided into 2 treatment groups

Group A: Investigational armExperimental treatment 4 interventions

Group B: Control armActive comparator 3 interventions

Trial outcomes

Primary outcomes

Overall survival (OS)

To evaluate the efficacy of a sequential treatment of Re-RCT followed by pembrolizumab compared to standard therapy with pembrolizumab ± chemotherapy, the primary endpoint of the trial is overall survival rate at 2 years.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universität des Saarlandes

Lead sponsor

Source ClinicalTrials.gov

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