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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.
Must not have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I agree to follow the specified contraception guidelines and not donate sperm for 150 days after my last treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am mostly active and have good organ function.
Select...
I am 18 or older with a new diagnosis of Stage II-IVb PNS SCC and have not started treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with specific immune therapy drugs before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: pembrolizumab, docetaxel, and cisplatin or carboplatinExperimental Treatment4 Interventions
IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,594 Total Patients Enrolled
Bonnie GlissionPrincipal InvestigatorM.D. Anderson Cancer Center
Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the specified contraception guidelines and not donate sperm for 150 days after my last treatment.I am fully active or restricted in physically strenuous activity but can do light work.My recent blood tests show my organs are functioning well.I have provided a recent or past biopsy of my tumor that was not treated with radiation.I am not pregnant, not breastfeeding, and either cannot become pregnant or agree to follow birth control guidelines.I am mostly active and have good organ function.I have been treated with specific immune therapy drugs before.I haven't had cancer treatment or radiation for PNS SCC, but may have for other cancers over 2 years ago.I am 18 or older with a new diagnosis of Stage II-IVb PNS SCC and have not started treatment.I am not pregnant, not breastfeeding, and either cannot become pregnant or agree to follow birth control guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: pembrolizumab, docetaxel, and cisplatin or carboplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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