Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)

Who is this study for? Patients with Squamous Cell Carcinoma in the Nasal Cavity
What treatments are being studied? Pembrolizumab+Docetaxel+Cisplatin+Carboplatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single arm phase II study that will evaluate the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as single treatment modality in patients with stage II-IVb (T2-4, any N, M0) squamous cell carcinoma of the nasal cavity/paranasal sinuses (PNS SCC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Male/female participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and/or cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.

⁃ Male participants:

⁃ A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period.

• Female participants:

⁃ A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:

‣ Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR

‣ A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.

• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.

∙ Have measurable disease based on RECIST 1.1.

∙ Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.

∙ Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Renata Ferrarotto
rferrarotto@mdanderson.org
(713) 745-6774
Time Frame
Start Date: 2021-11-02
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 35
Treatments
Other: pembrolizumab, docetaxel, and cisplatin or carboplatin
IV
Authors
Bonnie Glission
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov