Pembrolizumab and Induction Chemotherapy in Head and Neck Squamous Cell Carcinoma (PICH Study)
NCT03114280 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2019-04-08
Summary
Non-randomized phase I/II, open-labeled clinical study, 1-arm, multicenter, of docetaxel (T), cisplatin (P), 5-fluorouracil (F) and pembrolizumab every 21 days for 3 cycles followed by radiotherapy (RT) combined with carboplatin in untreated unresectable locally-advanced Head and Neck Squamous Cell Carcinoma (HNSCC).
The TPF and pembrolizumab combination will be called TP²F.
Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions
- DRUG
-
TPF2
Combination drugs : docetaxel (T), cisplatin (P), 5 Fluorouracil (F) and pembrolizumab every 21 days
- OTHER
-
Radiotherapy with carboplatin
Radiotherapy (RT) combined with carboplatin
Sponsors & Collaborators
-
GORTEC
collaborator OTHER -
GERCOR - Multidisciplinary Oncology Cooperative Group
collaborator OTHER -
Centre Antoine Lacassagne
lead OTHER
Principal Investigators
-
Chrisine LOVERA · Centre Antoine Lacassagne
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-12
- Primary Completion
- 2019-03-12
- Completion
- 2019-03-12
Countries
- France
Study Locations
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