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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05027633
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    given by IV
  • Docetaxel — DRUG
    given by IV
  • Cisplatin — DRUG
    given by IV
  • Carboplatin — DRUG
    given by IV

Study Details

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).

Key Dates

Start date
Nov 2, 2021
Status verified
Mar 2026
Primary completion
Mar 30, 2028
Completion
Mar 30, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: pembrolizumab, docetaxel, and cisplatin or carboplatin
    IV

Primary Outcome Measure

To increase overall response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Renata Ferrarotto
[email protected]
713-745-6774
Renata Ferrarotto (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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