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NCT03114280 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114280 on ClinicalTrials.gov