Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer (NCT04030455) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer
United States28 participantsStarted 2019-08-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Newly diagnosed, previously untreated, histologically confirmed stage II to III larynx squamous cell carcinoma will be enrolled in this study
* A male participant must agree to use a contraception during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
* Not a woman of childbearing potential (WOCBP) OR
* A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 150 days after the last dose of study treatment
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Have provided archival tumor tissue sample (minimum of 20 unstained slides) or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation
* Absolute neutrophil count (ANC) \>= 1500/ul (within 10 days prior to the start of study treatment)…
What they're measuring
1
CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD)
Timeframe: CBR after 2 cycles (6 weeks), pCR after 4 cycles (12 weeks), end of study (up to 3 years)