Combination of immunotherapy and chemotherapy for advanced nasal cavity cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia

  This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.

  Recruiting at 2 sites Phase 1 Rockefeller University · Minneapolis, Minnesota and 1 other locations · NCT07901959

• Two-photon microscopy on skin biopsies to help diagnose skin lesions

  This study tests whether images from two-photon fluorescence microscopy of dermatology biopsies can match the diagnosis determined by standard histology.

  Recruiting University of Rochester · Victor, New York · NCT07773688

• Targeted dual-imaging helper for head and neck cancer surgery

  This study tests whether using two imaging agents during surgery can help doctors see tumors and cancerous lymph nodes in adults with head and neck squamous cell carcinoma.

  Recruiting Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07741643

• Methionine-Reduced Diet in Solid Tumors (early-phase)

  A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.

  Recruiting Early Phase 1 University of California, Irvine · Orange, California · NCT07628634

• IDP-001 in advanced or metastatic solid tumors (including head and neck and skin cancers)

  A first- and second-phase study will test IDP-001 in people with advanced or metastatic solid tumors to see if it is safe and tolerable and to look for signs of activity.

  Recruiting at 6 sites Phase 1/2 InduPro, Inc. · Los Angeles, California and 5 other locations · NCT07602842

• Omitting postoperative radiation after HPV-related oropharyngeal cancer guided by ctHPVDNA monitoring

  This study tests whether some patients with HPV-related OPSCC can skip postoperative radiation after surgery if their tumors are low risk and ctHPVDNA looks negative.

  Recruiting Phase 2 Medical University of South Carolina · Charleston, South Carolina · NCT07513389

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.