Clinical Trials Logo
  1. Home
  2. Neoplasms, Head and Neck
  3. NCT04428333

Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma — INDUCE-4  

Neoplasms, Head and Neck Clinical Trial

Official title:
A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Clinical Trial Summary

The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04428333
Study type Interventional
Source GlaxoSmithKline
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date August 13, 2020
Completion date September 19, 2023
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01370876 - Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT03178110 - Manual Therapy and Use of the Dynasplint for Trismus in Patients With Head and Neck Cancer N/A
Terminated NCT04128696 - Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 2/Phase 3
Completed NCT00798655 - Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer Phase 2
Completed NCT00387127 - Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer Phase 2
Recruiting NCT06062420 - Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Phase 2
Active, not recruiting NCT04260126 - Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC Phase 2
Active, not recruiting NCT02296684 - Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma Phase 2
Recruiting NCT06256588 - A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma Phase 3
Completed NCT01116336 - Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck Phase 1
Completed NCT01110980 - Normalcy of Food Intake in Head and Neck Cancer Patients N/A
Recruiting NCT02557048 - Head and Neck Cancer in Children: A Retrospective Study
Completed NCT03356093 - Change in Symptom Clusters in HNC Patients N/A
Terminated NCT02376699 - Safety Study of SEA-CD40 in Cancer Patients Phase 1
Completed NCT00424255 - Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery Phase 3
Completed NCT00725764 - Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck Phase 2
Active, not recruiting NCT02573493 - Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC) Phase 2