A Phase 2 interventional study of Pembrolizumab and Docetaxel in Squamous Cell Carcinoma, the Nasal Cavity and Paranasal Sinuses, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
Among 17 studies testing pembrolizumab in Carcinoma, Squamous Cell — 3 open to participants now, 7 under way, none of them phase 3. pembrolizumab · Carcinoma, Squamous Cell.
Among the 17 studies testing pembrolizumab in Carcinoma, Squamous Cell, this one is the 11th largest by planned enrollment, is one of 3 that started in 2021, is one of 13 in phase 2, and was the 13th registered.
627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.
This study's planned enrollment of 35 is below the median of 45 across 476 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →3 of the 17 studies testing pembrolizumab in Carcinoma, Squamous Cell are open now, in 1 country. Each count lists the studies.
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 100 Carcinoma, Squamous Cell studies recruiting now, 84 (84%) set no upper age limit and 8 (8%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
17 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2021.
Median enrollment 48 across the 17 interventional studies. Of the 10 that completed or were terminated, 7 (70%) have results posted.
4 of 17 have an industry lead sponsor. The 10 most frequent:
M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
18 studies in Carcinoma, Squamous Cell by M.D. Anderson Cancer Center: 2 open now, 4 under way, none of them phase 3. Of 10 finished, 6 (60%) have results posted.
Among the 18 studies in Carcinoma, Squamous Cell by M.D. Anderson Cancer Center, this one is the 7th largest by planned enrollment of the 16 interventional ones, is the only one that started in 2021, is one of 10 in phase 2, and was the 14th registered.
M.D. Anderson Cancer Center’s Carcinoma, Squamous Cell studies by the year they started, since 1994.
1 of the studies testing pembrolizumab in Carcinoma, Squamous Cell that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05366166UNC Lineberger Comprehensive Cancer CenterPembrolizumab Plus Olaparib in LA-HNSCC | 2027-01-21 |
Among the 17 studies testing pembrolizumab in Carcinoma, Squamous Cell, from their registry updates:
Among M.D. Anderson Cancer Center’s 18 in Carcinoma, Squamous Cell:
Nothing recorded among them since 2026-09-25.
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).
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A male participant must agree to use a 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:
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IV
Drug: Pembrolizumab · Drug: Docetaxel · Drug: Cisplatin · Drug: Carboplatin
given by IV
given by IV
given by IV
given by IV
To increase overall response rate (ORR)
Time frame: through study completion, an average of 1 year
To improve the following efficacy endpoints relative to historical results with chemotherapy alone
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
Plan to share: No
Started Nov 2021 (actual). Primary completion is estimated for Mar 2028, 76 months after the start.
Of 86 non-industry phase 2 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 82. This study's planned 76 months is above that.
Counting every sponsor, half of 97 studies reached it within 61 months; a quarter within 37 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Pembrolizumab · Docetaxel · Cisplatin · Carboplatin