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First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT04858269
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : August 9, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Head Neck Cancer Metastatic Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma Hypopharynx Squamous Cell Carcinoma Larynx Squamous Cell Carcinoma Drug: Pembrolizumab Drug: Carboplatin Drug: Paclitaxel Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: Pembrolizumab
Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle

Drug: Carboplatin
Carboplatin dosed for area under the curve (AUC) 1.5 IV on days 1, 8, 15 of each 3-week cycle

Drug: Paclitaxel
Paclitaxel 45 mg/m2 on days 1, 8, 15 of 3-week cycle.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 3 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

  2. Progression-Free Survival [ Time Frame: Up to 3 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858269


Contacts
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Contact: Study Nurse 336-713-5440 saverill@wakehealth.edu
Contact: Jeffrey Kettler 336-713-5440 jkettler@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Study Nurse       saverill@wakehealth.edu   
Principal Investigator: Thomas Lycan, Jr., DO         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Thomas Lycan, DO Wake Forest Baptist Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04858269    
Other Study ID Numbers: IRB00072117
WFBCCC 60121 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Paclitaxel
 Carboplatin
Pembrolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological