Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC
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
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
Treatments tested in this trial
- radiotherapy
- Cisplatin
- Pembrolizumab
- cisplatin + 5-fluorouracil (5FU)
- Alternative medications: carboplatin + 5-fluorouracil (5FU)
- Alternative medications: carboplatin
- Pembrolizumab
Treatment groups
214 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov