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Chemotherapy

Immunotherapy + Chemotherapy for Nasal and Sinus Cancer

Phase 2

Recruiting

Led By Bonnie Glission

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test if pembrolizumab, docetaxel, and cisplatin or carboplatin can effectively treat stage II-IVb squamous cell carcinoma of the PNS.

Who is the study for?

Adults with newly diagnosed, untreated Stage II-IVb squamous cell carcinoma of the nasal cavity/paranasal sinuses. Participants must have measurable disease, provide a tissue sample, not be pregnant or breastfeeding, agree to use contraception and have good organ function. Excludes those who've had prior cancer treatments for PNS SCC or immunotherapy.Check my eligibility

What is being tested?

The trial is testing a combination therapy (PDC) involving pembrolizumab (an immunotherapy drug) and chemotherapy drugs docetaxel and either cisplatin or carboplatin in patients with advanced squamous cancer of the nasal cavity/paranasal sinuses.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, nausea, hair loss from chemotherapy drugs docetaxel and platinum-based cisplatin/carboplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to follow the specified contraception guidelines and not donate sperm for 150 days after my last treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am mostly active and have good organ function.

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I am 18 or older with a new diagnosis of Stage II-IVb PNS SCC and have not started treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To increase overall response rate (ORR)

Secondary outcome measures

To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC

To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC

To improve the following efficacy endpoints relative to historical results with chemotherapy alone

Trial Design

1Treatment groups

Experimental Treatment

Group I: pembrolizumab, docetaxel, and cisplatin or carboplatinExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,281 Total Patients Enrolled

Bonnie GlissionPrincipal InvestigatorM.D. Anderson Cancer Center

Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

134 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05027633 — Phase 2

Squamous Cell Carcinoma Research Study Groups: pembrolizumab, docetaxel, and cisplatin or carboplatin

Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05027633 — Phase 2

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027633 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what circumstances is this treatment typically administered?

"This innovative treatment is capable of treating head, melanoma and metastatic ureter urothelial carcinomas."

Answered by AI

Are there vacancies available for participants of this research study?

"Affirmative. Clinicaltrials.gov data suggest that recruitment for this clinical trial, which was launched on November 2nd 2021, is currently ongoing. 35 patients are required to join from a single medical site."

Answered by AI

What is the sample size of subjects taking part in this research?

"Affirmative. According to the information present on clinicaltrials.gov, this experiment is recruiting participants currently. It was initially advertised on November 2nd 2021 and was last modified July 10th 2022. 35 patients are needed across a single medical centre for successful completion of the study."

Answered by AI

Has this treatment gained approval from the Federal Drug Administration?

"After assessing the risks associated with this Phase 2 trial, our team at Power assigned a score of 2 to indicate that there is evidence supporting safety but none backing efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05027633.