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

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).

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma; the Nasal Cavity; Paranasal Sinuses
• Intervention / Treatment: Drug: Pembrolizumab; Drug: Docetaxel; Drug: Cisplatin; Drug: Carboplatin

Detailed Description

Primary Objective

-Increase overall response rate (ORR), following pembrolizumab combined with induction chemotherapy prior to radiation, from historical 60% with induction chemotherapy alone to 80%.

Secondary Objective

• Improve the following efficacy endpoints relative to historical results with chemotherapy alone: progression free survival (PFS), overall survival (OS), organ [orbital, maxillary, cranial] preservation rate (OPR), and locoregional failure (LRF).
• To determine safety and tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC.
• Correlate immune phenotype in tumors and blood, including T cell infiltration and PD-L1 status, with treatment outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Renata Ferrarotto; Phone Number: (713) 745-6774; Email: rferrarotto@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Renata Ferrarotto; Phone Number: 713-745-6774; Email: rferrarotto@mdanderson.org
      • Principal Investigator: Renata Ferrarotto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: pembrolizumab, docetaxel, and cisplatin or carboplatin; IV	Drug: Pembrolizumab; given by IV; Drug: Docetaxel; given by IV; Drug: Cisplatin; given by IV; Drug: Carboplatin; given by IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To increase overall response rate (ORR)	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To improve the following efficacy endpoints relative to historical results with chemotherapy alone	through study completion, an average of 1 year
To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC	through study completion, an average of 1 year
To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Renata Ferrarotto, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Docetaxel; Carboplatin; Cisplatin; pembrolizumab
• Other Study ID Numbers: 2020-1109; NCI-2021-09409 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No