Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well cisplatin, docetaxel, and pembrolizumab work in treating patients with stage II-III laryngeal cancer. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin, docetaxel, and pembrolizumab may help to control the disease.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the clinical benefit rate (CBR) of patients with stage II or III larynx squamous cell carcinoma (SCC) after 2 cycles of pembrolizumab, cisplatin and docetaxel (PCD), and the pathologic complete response (pCR) rate after 4 cycles of PCD. SECONDARY OBJECTIVES: I. To determine safety and tolerability of PCD in patients with larynx SCC. II. To determine the laryngeal preservation rate (LPR) at 2 years in the overall population and in the subgroup who achieves a pCR. III. To determine the 2 year relapse-free survival (RFS) and overall survival (OS) in the overall population and in the subgroup who achieves a pCR. IV. To determine patient-reported outcomes (PROs) using M. D. Anderson Symptom Inventory-Head and Neck (MDASI-HN) and swallow function using Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). EXPLORATORY OBJECTIVES: I. To assess predictive tissue and blood-based biomarkers of benefit from PCD in larynx SCC. OUTLINE: Patients receive cisplatin intravenously (IV) over 1 hour, docetaxel IV over 1 hour (patients who develop significant adverse events to cisplatin treatment may receive carboplatin IV over 1 hour instead), and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who completely respond to the study drugs (the disease appears to go away) then receive pembrolizumab IV over 30 minutes on day 1 for 4 additional cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 weeks, then every 6-12 weeks for up to 2 years. ;


Study Design


Related Conditions & MeSH terms

  • Laryngeal Neoplasms
  • Laryngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Stage II Laryngeal Cancer AJCC v8
  • Stage III Laryngeal Cancer AJCC v8

NCT number NCT04030455
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 7, 2019
Completion date March 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05172245 - Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer Phase 1
Completed NCT04870840 - Image-guided Proton Therapy for the Treatment of Locally Advanced Unresectable Head and Neck Cancer Phase 1
Completed NCT04541355 - Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin Phase 2
Suspended NCT04162873 - Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer Phase 2
Recruiting NCT02734537 - Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery Phase 2
Completed NCT04788264 - Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment N/A
Active, not recruiting NCT04576091 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer Phase 1
Recruiting NCT05136196 - BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study Phase 2
Recruiting NCT03010150 - Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
Recruiting NCT04533750 - Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin Phase 1
Withdrawn NCT05512767 - A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation N/A
Active, not recruiting NCT03258554 - Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin Phase 2/Phase 3
Not yet recruiting NCT06084845 - Testing the Addition of an Investigational Drug, Xevinapant, to Usual Radiation Therapy Plus Cisplatin/Carboplatin for Patients With Head and Neck Cancer Phase 2