NCT03088059

Biomarker-based Study in R/M SCCHN

A Pilot Study of Personalized Biomarker-based Treatment Strategy or Immunotherapy in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.

Conditions

• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
DRUG	Afatinib	Afatinib 40 mg given orally, once daily, 1 cycle is 28 days
DRUG	Palbociclib	Palbociclib 125 mg given orally, once daily, 1 cycle is 28 days (21 days on treatment, then 7 days off)
DRUG	standard of care	Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care
DRUG	IPH2201	protocol v2.0 and 2.1 : Monalizumab 10mg/kg given intravenously over 60 minutes, once every 14 days, 1 cycle is 14 days protocol v4.0 : Monalizumab 750mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days
DRUG	Durvalumab	Durvalumab 1500mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days
DRUG	Niraparib	Niraparib 300 mg given orally, once daily, 1 cycle is 28 days
DRUG	INCAGN01876	INCAGN01876 300 mg given intravenously over 30 minutes, once every 14 days, 1 cycle is 28 days

Timeline

• Start date: 2017-11-16
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2017-03-23
• Last updated: 2023-11-03

Locations

36 sites across 5 countries: Belgium, France, Italy, Spain, United Kingdom