Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase II Trial of the Efficacy and Safety of the Combination of Cemiplimab and Low-Dose Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
2 other identifiers
interventional
46
1 country
1
Brief Summary
This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedStudy Start
First participant enrolled
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedFebruary 10, 2026
February 1, 2026
4.5 years
March 26, 2021
February 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
ORR defined as the proportion of patients with a documented complete response (CR) + partial response (PR) at week 12 of treatment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. An ORR of 40% (percent) or higher will be consider a positive result. Simon two-stage optimal design will be used.
12 weeks
Secondary Outcomes (3)
Progression-free survival (PFS)
From the date of enrollment until documented disease progression, assessed up to 2 years
Overall survival (OS)
From the date of patient enrollment into the trial until death, assessed up to 2 years
Incidence of adverse events
Up to 24 weeks
Other Outcomes (5)
Ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin
Up to 24 weeks
PFS of patients with combined positive score (CPS) < 1%, > 1%, and > 20%
Up to 2 years
OS of patients with CPS < 1%, > 1%, and > 20%
Up to 2 years
- +2 more other outcomes
Study Arms (1)
Treatment (cemiplimab, paclitaxel, carboplatin)
EXPERIMENTALPatients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.
Interventions
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Recurrent/metastatic (R/M) SCCHN of the oral cavity, oropharynx, larynx and hypopharynx
- No prior systemic therapy for treatment of R/M disease
- Patients with squamous cell carcinoma of an unknown primary are eligible provided their tumor tested positive for p-16 and they have previously received treatment for locoregional head and neck cancer
- Must be at least four weeks since prior radiation and/or surgery
- Must be at least four weeks from curative intent systemic therapy. Of note: patients who have received up to two courses of chemoradiotherapy (CRT) for locoregionally advanced disease are eligible. Induction chemotherapy will not be considered a separate line of therapy
- At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
- years of age and older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- White blood cell (WBC) count \> 2,500 cells/uL
- Absolute neutrophil count (ANC) \>1,500 cells/uL
- Platelet count \>= 100,000 cells/uL
- Hemoglobin \>= 9 g/dL
- Creatinine =\< 1.6 mg/dL
- Total bilirubin =\< 1.6 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase \[AST\]), serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x upper limit of normal (ULN)
- +4 more criteria
You may not qualify if:
- Disease amenable to curative local therapy
- Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma
- Disease that requires corticosteroids or other ongoing immunosuppressive treatment
- Previous treatment with mAb-based immunotherapy for treatment of prior oncologic treatment
- Previous treatment with PI3K inhibitors
- Known brain metastases, unless stable for at least 21 days prior to registration
- Known infection human immunodeficiency virus (HIV), hepatitis B or C
- Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months
- History of pneumonitis within the past five years
- Recipient of live vaccines (including attenuated) within 30 days of planned study treatment
- Female patients who are pregnant or breast-feeding
- Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements or otherwise compromise the study's objectives in the opinion of the Principal Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marcelo Bonomilead
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo R Bonomi, MD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2021
First Posted
April 28, 2021
Study Start
November 30, 2021
Primary Completion
May 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share