Combination of immunotherapy and chemotherapy for advanced nasal cavity cancer
Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
This study is testing a new treatment that combines immunotherapy with chemotherapy to see if it can help people with advanced nasal cavity cancer respond better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation, pembrolizumab, chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05027633 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the effectiveness of pembrolizumab combined with chemotherapy (docetaxel and cisplatin or carboplatin) in treating patients with stage II-IVb squamous cell carcinoma of the nasal cavity and paranasal sinuses. The primary goal is to increase the overall response rate from 60% to 80% compared to historical data. Secondary objectives include improving progression-free survival, overall survival, and organ preservation rates, while also assessing the safety and tolerability of the treatment. The study will also explore the correlation between immune characteristics in tumors and blood with treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, untreated stage II-IVb squamous cell carcinoma of the nasal cavity or paranasal sinuses.
Not a fit: Patients with early-stage disease or those who have received prior treatment for their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve response rates and survival outcomes for patients with advanced nasal cavity cancer.
How similar studies have performed: Other studies combining immunotherapy with chemotherapy have shown promising results, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Renata Ferrarotto — M.D. Anderson Cancer Center
- Study coordinator: Renata Ferrarotto
- Email: rferrarotto@mdanderson.org
- Phone: (713) 745-6774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.