Combination chemo treatment for recurrent / metastatic head and neck cancer
A Phase 4, single-arm, open-label clinical study of pembrolizumab (MK- 3475) to evaluate the efficacy and safety of MK-3475 plus carboplatin and paclitael as firstline treatment of recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE10).
This study looks at the safety and efficacy of the combination of Pembrolizumab, Carboplatin, & Paciltaxel for patients with incurable head and neck cancer that has returned after being treated or has spread to other body parts. The study will take place at ECMC and can last 2-3 years.
This is a nonrandomized, single-arm, multisite, open-label study of intravenous
pembrolizumab (also known as MK-3475) combined with carboplatin and paclitaxel in
participants with R/M HNSCC who have not previously received systemic therapy in the
R/M setting (1L intervention). This Phase 4 study will be conducted in participants who have
measurable disease per RECIST 1.1 as assessed by BICR, an ECOG performance status of 0
or 1, and have a tumor that is considered incurable by local therapies. Participants will receive combined treatment with pembrolizumab, carboplatin, and the investigators choice of paclitaxel dose (paclitaxel 100 mg/m2 Q1W or paclitaxel 175 mg/m2
Q3W) for 6 cycles or until a discontinuation criterion is met. Treatment with pembrolizumab
will continue for up to 35 cycles, or until a discontinuation criterion (Section 7.1) is met. If the safety profile is acceptable and this combination improves ORR, this study could support the combination of pembrolizumab with carboplatin and paclitaxel and provide
additional treatment options for participants with 1L recurrent/metatstatic H&N Squamous Cell Carcinoma.
-Has histologically or cytologically-confirmed diagnosis of recurrent / metastatic head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
-Has not had prior systemic therapy administered in the recurrent or metastatic setting.
Systemic therapy, which was completed more than 6 months prior to signing consent,
if given as part of multimodal treatment for locally advanced disease, is allowed.
-Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.
-Does not have a primary tumor site of nasopharynx (any histology)
-Does not have an unknown primary tumor.
-Does have M1/Stage IV disease if newly-diagnosed with HNSCC.
-Has an ECOG performance status of 0 or 1.
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the
contact information above or email email@example.com and someone will assist you.
Your information will be shared only with the research study team for recruitment purposes and designated CTSI personnel for project quality
assurance and will remain confidential. Your information will be stored indefinitely. Should you no longer want this information to be provided
in the aforementioned ways, please contact firstname.lastname@example.org.