- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04858269
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
March 5, 2024 updated by: Wake Forest University Health Sciences
Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Primary Objective: To determine if six (6) cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients increases the radiographic response rate as compared to the historical rate for pembrolizumab alone.
Secondary Objective(s):
- To determine if six (6) cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients increases median overall survival (OS) as compared to the historical rate reported for pembrolizumab alone.
- To determine if six (6) cycles of pembrolizumab with weekly carboplatin and paclitaxel followed by pembrolizumab alone for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients increases the median progression-free survival (PFS) as compared to the historical rate reported for pembrolizumab alone.
- To determine the toxicity profile of six (6) cycles of pembrolizumab with weekly carboplatin/paclitaxel/pembrolizumab alone for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients, measured as the proportion of patients with discontinuation of any study drug due to any adverse event of any cause, as compared to the historical proportion reported for platinum/5FU/ pembrolizumab (33%).
Study Type
Interventional
Enrollment (Estimated)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Nurse
- Phone Number: 336-713-5440
- Email: saverill@wakehealth.edu
Study Contact Backup
- Name: Jeffrey Kettler
- Phone Number: 336-713-5440
- Email: jkettler@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Baptist Health Sciences
-
Principal Investigator:
- Thomas Lycan, Jr., DO
-
Contact:
- Study Nurse
- Email: saverill@wakehealth.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or neck node with occult primary but suspected to be non-cutaneous head/neck that is incurable by local therapies (i.e. radiation or surgery) and either locoregionally advanced or with at least one distant metastasis.
- Histologic or cytologic confirmation of malignancy by pathology report.
- Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other).
- 18 years old or greater.
- ECOG performance status of 0-2.
- Life expectancy of greater than 3 months.
- Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion Criteria:
- No prior systemic cancer-directed therapy administered in the recurrent or metastatic setting. Prior treatments are allowed if they were administered with curative intent prior to incurable progression of disease. Prior treatments for other cancers are also allowed.
- Untreated, symptomatic central nervous system (CNS) metastases.
- Active autoimmune disease requiring systemic immunosuppression.
- History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for >1 week).
- History of greater than or equal to Grade 3 hypersensitivity reaction to carboplatin or paclitaxel.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because paclitaxel and carboplatin are Class D agents with significant potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combination of Chemotherapy and Immunotherapy
The intervention will be administered on an outpatient basis.
The treatment regimen will consist of combination chemotherapy and immunotherapy administered as: Pembrolizumab PLUS Carboplatin PLUS Paclitaxel.
|
Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle
Carboplatin dosed for area under the curve (AUC) 1.5 IV on days 1, 8, 15 of each 3-week cycle
Paclitaxel 45 mg/m2 on days 1, 8, 15 of 3-week cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: At 18 weeks on study
|
Using RECIST 1.1 will be defined as the percentage of analyzed participants with a complete response - defined as disappearance of all target lesions; or partial response - defined as decrease by ≥ 30% in sum of longest diameter of target lesions when compared to the historical objective response rate (19%) reported for pembrolizumab alone; stable disease (SD): Not meeting criteria for CR, PR, or PD; progressive disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions.
|
At 18 weeks on study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Discontinuation of Study Drug due to Adverse Effects of Any Cause
Time Frame: Up to 18 weeks
|
Participants with discontinuation of any study drug due to adverse events of any cause before 18 weeks as compared to the historical value reported for platinum/5FU/pembrolizumab.
|
Up to 18 weeks
|
Overall Survival
Time Frame: Up to 2 years
|
Median survival rate will be defined as the time from study registration to death due to any cause and as compared to the historical median reported for pembrolizumab alone.
The Kaplan-Meier method will be used to generate survival curves with the intention-to-treat population.
Data for patients who are alive or lost to follow-up will be censored for overall survival at the date they were last known to be alive
|
Up to 2 years
|
Progression-Free Survival
Time Frame: Up to 2 years
|
Median progression-free survival (PFS) defined as the time from study registration to the first documented progressive disease (PD) per RECIST v1.1 criteria (defined as increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions) based on non-blinded central imaging or else death due to any cause, whichever occurred first; and as compared to the historical value reported for pembrolizumab alone.
The Kaplan-Meier method will be used to generate survival curves with the intention-to-treat population.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Thomas Lycan, DO, Wake Forest Baptist Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2021
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
April 21, 2021
First Submitted That Met QC Criteria
April 21, 2021
First Posted (Actual)
April 26, 2021
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Carboplatin
- Paclitaxel
- Pembrolizumab
Other Study ID Numbers
- IRB00072117
- P30CA012197 (U.S. NIH Grant/Contract)
- WFBCCC 60121 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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