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

NCT04858269 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00072117WFBCCC 60121P30CA012197
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Head Neck Cancer; Metastatic Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma; Oropharynx Squamous Cell Carcinoma; Hypopharynx Squamous Cell Carcinoma; Larynx Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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) as compared to the historical objective response rate (19%) reported for pembrolizumab alone.

  At 18 weeks on study

Secondary Outcomes (3)

• Overall Survival

  Up to 2 years

• Progression-Free Survival

  Up to 2 years

• Number of Participants with Discontinuation of Study Drug Due to Adverse Effects of Any Cause

  Up to 18 weeks

Study Arms (1)

Combination of Chemotherapy and Immunotherapy

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle

Combination of Chemotherapy and Immunotherapy

Carboplatin DRUG

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

Combination of Chemotherapy and Immunotherapy

Paclitaxel DRUG

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

Combination of Chemotherapy and Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Thomas Lycan, DO

  Wake Forest Baptist Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: May 27, 2021
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)