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Platinum-based Chemotherapy
Chemotherapy + Immunotherapy for Laryngeal Cancer
Phase 2
Waitlist Available
Led By Renata Ferrarotto
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed, previously untreated, histologically confirmed stage II to III larynx squamous cell carcinoma will be enrolled in this study
Creatinine OR measured or calculated (creatinine clearance [CrCl] should be calculated per institutional standard) creatinine clearance (glomerular filtration rate [GFR]: can also be used in place of creatinine or CrCl): =< 1.5 x ULN OR >= 30 mL/min for participant with creatinine levels > 1.5 x institutional upper limit of normal (ULN) (within 10 days prior to the start of study treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study Summary
This trial is studying a combination of cisplatin, docetaxel, and pembrolizumab to see how well it works compared to cisplatin and docetaxel in treating patients with stage II-III laryngeal cancer.
Who is the study for?
This trial is for adults with newly diagnosed, untreated stage II-III laryngeal squamous cell carcinoma. Participants must be able to use contraception and not be pregnant or breastfeeding. They should have a good performance status (able to carry out daily activities), adequate organ function, and no recent history of other cancer treatments or certain infections like hepatitis B/C or HIV.Check my eligibility
What is being tested?
The study tests the effectiveness of combining chemotherapy drugs cisplatin and docetaxel with an immunotherapy drug called pembrolizumab in treating laryngeal cancer. The goal is to see if this combination helps control the disease by killing tumor cells and boosting the immune system's response.See study design
What are the potential side effects?
Possible side effects include reactions related to chemotherapy such as nausea, hair loss, fatigue, increased risk of infection due to low blood counts, kidney issues from cisplatin; plus potential immune-related side effects from pembrolizumab like inflammation in various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with stage II to III larynx cancer and have not received any treatment.
Select...
My kidney function, measured by creatinine clearance or GFR, is within the required range.
Select...
My hemoglobin level is above 9.0 g/DL without needing transfusions or erythropoietin in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate
Pathological complete response rate
Secondary outcome measures
Incidence of adverse events
Laryngeal preservation rate
Overall survival
+2 moreOther outcome measures
Predictive tissue and blood-biomarkers of benefit
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cisplatin, docetaxel, pembrolizumab)Experimental Treatment4 Interventions
Patients receive cisplatin 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,640 Total Patients Enrolled
3 Trials studying Laryngeal Cancer
1,184 Patients Enrolled for Laryngeal Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,775 Total Patients Enrolled
1 Trials studying Laryngeal Cancer
155 Patients Enrolled for Laryngeal Cancer
Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on IV antibiotics for an infection.I have not received a live vaccine in the last 30 days.My liver function tests are within the required range.I have provided a recent or archived sample of my tumor for testing.I have been newly diagnosed with stage II to III larynx cancer and have not received any treatment.I am fully active or restricted in physically strenuous activity but can do light work.I have another cancer besides skin, early-stage breast, cervical, or monitored prostate cancer that needed treatment in the last 2 years.I have had pneumonitis treated with steroids or have it now.I haven't had cancer treatment or major surgery in the last 4 weeks and have recovered from side effects.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.Your platelet count is at least 100,000 per microliter within the 10 days before starting the study treatment.My kidney function, measured by creatinine clearance or GFR, is within the required range.I have had a solid organ or bone marrow transplant.Your white blood cell count is within a certain range.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have a history of hepatitis B or active hepatitis C.I am not on high-dose steroids or other drugs that weaken my immune system, except for short-term dexamethasone.I agree to use birth control and not donate sperm for 150 days after my last treatment.I have been treated with specific immune therapy for cancer.My hemoglobin level is above 9.0 g/DL without needing transfusions or erythropoietin in the last 2 weeks.My blood clotting tests are normal or within treatment range if I'm on blood thinners.Your bilirubin levels must be within a certain range, and if they are too high, you may not be eligible for the study.You have a known history of HIV.I have an active tuberculosis infection.You have mental health or drug problems that would make it hard for you to follow the trial rules.You have a tumor that can be measured using specific guidelines for evaluating tumors.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cisplatin, docetaxel, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently involved in this experiment?
"Correct. According to the data posted on clinicaltrials.gov, this particular investigation is currently seeking participants and was initially uploaded on August 7th 2019 with a recent update recorded for August 10th 2022. 25 individuals are required from one facility."
Answered by AI
What conditions can Pembrolizumab be utilized to treat?
"The immunotherapy drug pembrolizumab is a viable treatment option for head and neck cancer, melanoma, and metastatic urothelial carcinoma."
Answered by AI
Is enrollment still open in this research project?
"Affirmative, the clinicaltrial.gov website indicates that this medical trial is actively seeking participants and has been since its posting on August 7th 2019. The study needs 25 individuals to join from one site in order to continue."
Answered by AI
Has Pembrolizumab gained authorization from the Food and Drug Administration?
"The safety of Pembrolizumab was judged to be a 2 on our scale due to the fact that, although there is evidence demonstrating its security, it has yet to demonstrate efficacy in any clinical studies."
Answered by AI
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