Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent ormetastatic PD-L1+ head and neck squamous cell carcinoma.
Description for laymen
A phase 3 randomized, open-label study to evaluate the efficacy and
safety of petosemtamab plus pembrolizumab vs pembrolizumab in
first-line treatment of recurrent or metastatic PD-L1+ head and neck
squamous cell carcinoma.
JSON Data
{
"short_title": "MCLA-158-CL03 ",
"data_mode": "900",
"data_mode_number": "000002443",
"official_title": "A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT06525220",
"eudract_number": null,
"general_contact_email": "oncostudy@ukdd.de",
"general_contact_phone": "+49 351-4587666",
"hauptpruefer_dd_name": "Dr. med. Ulrike Ubbelohde",
"description_laie_de": "Eine randomisierte, offene Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Petosemtamab plus Pembrolizumab im Vergleich zu Pembrolizumab in der Erstlinienbehandlung von rezidiviertem oder metastasiertem PD-L1+ Plattenepithelkarzinom im Kopf-Hals-Bereich.",
"description_laie_en": "A phase 3 randomized, open-label study to evaluate the efficacy and \r\nsafety of petosemtamab plus pembrolizumab vs pembrolizumab in \r\nfirst-line treatment of recurrent or metastatic PD-L1+ head and neck \r\nsquamous cell carcinoma.",
"description_expert_de": "Eine randomisierte, offene Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Petosemtamab plus Pembrolizumab im Vergleich zu Pembrolizumab in der Erstlinienbehandlung von rezidiviertem oder metastasiertem PD-L1+ Plattenepithelkarzinom im Kopf-Hals-Bereich.",
"description_expert_en": "This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent ormetastatic PD-L1+ head and neck squamous cell carcinoma.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "III",
"main_cat_id": 6,
"sub_cat_id": 37
}
