Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 1:53 PM
Study NCT ID:
NCT04862650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2021-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Marcelo Bonomi
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin.
SECONDARY OBJECTIVES:
I. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be performed initially).
II. To assess progression-free survival (PFS) and overall survival (OS) at one and two years.
EXPLORATORY OBJECTIVES:
I. Prospectively test the ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck (SCCHN) patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin.
II. To assess the PFS and OS of patients with combined positive score (CPS) \<1%, \>1%, and \> 20%.
III. Compare the predictive power of our nomogram to that of CPS in the prospective cohort, as well as evaluate the combined correlation of nomogram and CPS to median OS.
IV. Perform comprehensive immune analysis including phenotypic analysis of immune cell subsets using high dimensional spectral flow cytometry. T cell functionality and ability to produce cytokines after ex vivo stimulation for all T cells and E6/E7-reactive T cells (P16+ subset patients) and TCR sequencing to determine if clonal T cell populations emerge from the tumor of responding patients in comparison with non-responders.
OUTLINE:
Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 104 weeks, and paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes once weekly (QW) for up to 24 weeks. Treatment continuous in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 14 days and then every 12 weeks.
I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin.
SECONDARY OBJECTIVES:
I. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be performed initially).
II. To assess progression-free survival (PFS) and overall survival (OS) at one and two years.
EXPLORATORY OBJECTIVES:
I. Prospectively test the ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck (SCCHN) patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin.
II. To assess the PFS and OS of patients with combined positive score (CPS) \<1%, \>1%, and \> 20%.
III. Compare the predictive power of our nomogram to that of CPS in the prospective cohort, as well as evaluate the combined correlation of nomogram and CPS to median OS.
IV. Perform comprehensive immune analysis including phenotypic analysis of immune cell subsets using high dimensional spectral flow cytometry. T cell functionality and ability to produce cytokines after ex vivo stimulation for all T cells and E6/E7-reactive T cells (P16+ subset patients) and TCR sequencing to determine if clonal T cell populations emerge from the tumor of responding patients in comparison with non-responders.
OUTLINE:
Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 104 weeks, and paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes once weekly (QW) for up to 24 weeks. Treatment continuous in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 14 days and then every 12 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-02081 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |