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

Launched by M.D. ANDERSON CANCER CENTER · Aug 24, 2021

Keywords

ClinConnect Summary

The I-NAPA clinical trial is studying a new treatment approach for patients with advanced squamous cell carcinoma of the nasal cavity and paranasal sinuses. This trial combines three treatments: pembrolizumab (an immunotherapy), docetaxel, and either cisplatin or carboplatin (both chemotherapy drugs). The goal is to see how effective this combination is for patients who have not received any treatment before and have been diagnosed with stage II to IVb cancer.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of stage II to IVb squamous cell carcinoma of the nasal cavity or paranasal sinuses. They should not have received any previous treatments for this specific cancer. Both men and women can participate, but women must not be pregnant or breastfeeding and should follow specific contraceptive guidelines during the study and for a period after treatment. Participants can expect to receive the study treatments, regular check-ups, and monitoring throughout the trial to assess how well the treatment works and any side effects that may occur.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
• • 2. 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.
• Exclusion Criteria:
• • A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
• • Patients must not have received prior systemic anti-cancer therapy including investigational agents or radiation therapy for PNS SCC but could have received treatment for prior cancers if greater than 2 years (refer to Item 8 for further details).