Study on Cisplatin, Docetaxel, and Pembrolizumab for Treating Stage II-III Laryngeal Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04030455

Provider View

This clinical trial is testing a combination of chemotherapy drugs, cisplatin and docetaxel, with an immunotherapy drug, pembrolizumab, to see how well they work together in treating patients with stage II-III laryngeal cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the combination of chemotherapy drugs cisplatin and docetaxel, along with the immunotherapy drug pembrolizumab, can treat stage II-III laryngeal cancer. Chemotherapy drugs work by stopping cancer cells from growing and spreading, while immunotherapy helps the body's immune system attack the cancer. This study aims to see if this combination can effectively control the disease.

Description

The main goals of this study are to determine how effective the treatment is in controlling cancer and to assess the safety and side effects of the treatment. Patients will receive cisplatin, docetaxel, and pembrolizumab through an IV on the first day of each treatment cycle, which lasts 21 days. This will be repeated for up to 4 cycles unless the cancer progresses or side effects become too severe. If the cancer responds well, patients may continue to receive pembrolizumab for 4 more cycles. After completing the treatment, patients will have follow-up visits to monitor their health and the cancer's status every 6-12 weeks for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with stage II-III laryngeal cancer that has not been treated before.
  • Male participants must agree to use contraception during treatment and for 150 days after the last dose.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
  • Must provide written consent to participate in the study.
  • Must have measurable cancer based on specific medical criteria.
  • Must provide a tumor tissue sample for analysis.
  • Must be in good overall health with a performance status score of 0 or 1.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received prior treatment with similar immunotherapy drugs.
  • Have received other cancer treatments or participated in another clinical trial within 4 weeks before starting this study.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a diagnosis of immunodeficiency or are taking high doses of steroids or other immunosuppressive drugs.
  • Have another active cancer that requires treatment.
  • Have an active autoimmune disease that required treatment in the past 2 years.
  • Have a history of lung inflammation or current lung issues.
  • Have an active infection requiring IV antibiotics.
  • Have a history of HIV, hepatitis B, hepatitis C, or tuberculosis.
  • Have any condition that might interfere with the study results or participation.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Have had a solid organ or bone marrow transplant.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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