Effect of DrugPhase 2NCT05252429
Docetaxel/Pembrolizumab in Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Docetaxel and Pembrolizumab in people with Effect of Drug, run by Hokkaido University Hospital at 1 site in Japan.
Trial summary
Pembrolizumab monotherapy and platinum-based chemotherapy in the combination with pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have been widely used in daily clinical practice based on the KEYNOTE-048 study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Docetaxel and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteJapan
- Study dates
- 6 Jul 2022to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies.
- Subjects should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
- The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Subjects may not have a primary tumor site of nasopharynx (any histology).
- Be willing and able to provide written informed consent for the trial.
- Have results from testing of PD-L1 status.
- Be ≥ 20 years of age on day of signing informed consent.
Show all 13Show fewer
- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have a performance status of 0 or 1 on the ECO G Performance Scale.
- Have adequate organ function.
- Have results from testing of HPV status for oropharyngeal cancer.
- Female subjects of childbearing potential should have a negative blood pregnancy test within 72 hours prior to receiving the first dose of study medication.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose of study medication.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy.
Who cannot join
- Has disease that is suitable for local therapy administered with curative intent.
- Has a life expectancy of less than 3 months and/ or has rapidly progressing disease in the opinion of the treating investigator.
- Has received prior systemic anti-cancer therapy including radiation therapy, other non-systemic therapy or investigational agents within 4 weeks prior to the first dose of trial treatment.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy, or used an investigational device, any of which occurred within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (using prednisolone ≥ 10mg per day) or any other form of immunosuppressive therapy within 7 days prior to the first dos e of trial treatment.
- Has a diagnosed and/or treated additional malignancy within 2 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected esophageal cancer, curatively resected in situ cervical cancer, and curatively resected in situ cancer.
Show all 12Show fewer
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. Pneumonitis include active radiation pneumonitis.
- Has an active infection requiring systemic therapy.
- Has received prior therapy with an anti-PD-1, a nti-PD-L1, or anti-CTLA-4 agent.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA is detected).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase ll Trial of Docetaxel/Pembrolizumab Combination Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Pembrolizumab monotherapy and platinum-based chemotherapy in the combination with pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have been widely used in daily clinical practice based on the KEYNOTE-048 study. On the other hand, docetaxel is a commonly used antimitotic agent in cancer therapy and might have potent antitumor effect by the immune response. A combination therapy of docetaxel and pembrolizumab might be a promising treatment for R/M HNSCC. The KEYNOTE-048 study showed that pembrolizumab plus platinum and 5-fluorouracil is a tolerable treatment for R/M HNSCC. The main grade 3/4 adverse event of platinum and 5-fluorouracil was myelosuppression such as neutropenia similar to docetaxel in some studies for R/M HNSCC. The safety profile of platinum and 5-fluorouracil is not much different from docetaxel. Therefore, docetaxel/pembrolizumab combination treatment might also be tolerable. The hypothesis of this study is that a combination therapy of docetaxel and pembrolizumab will provide benefit for patients with R/M HNSCC.
- Conditions
- Effect of Drug
- Being tested
- Docetaxel, Pembrolizumab
- Keywords
- head and neck cancer, docetaxel, pembrolizumab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Docetaxel 75mg/m2; q21
PembrolizumabDrug
Also called Keytruda
Pembrolizumab 200mg, q21
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel plus pembrolizumab | Experimental | Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression or up to 35 cycles. Receives: Drug: Docetaxel; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate is estimated per RECIST 1.1 by blinded independent central review (BICR).
Measured: 1 year
Secondary outcomes (4)
Overall survival (OS)
For overall survival, the survival curve is estimated by the Kaplan-Meier method.
Measured: 1 year
Progression-free survival (PFS)
For progression-free survival, the survival curve is estimated by the Kaplan-Meier method.
Measured: 1 year
Duration of response (DoR)
For duration of response, the survival curve is estimated by the Kaplan-Meier method.
Measured: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Drug induced toxicities are assessed and graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: From treatment start date to 30 days after the final administration of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start6 Jul 2022
- Primary completion31 May 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hokkaido University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Yasushi Shimizu, Hokkaido University Hospital
- Investigators
- Yasushi Shimizu, Principal investigator, Hokkaido University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252429
- Sponsor's protocol ID
- 020-011
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase ll Trial of Docetaxel/Pembrolizumab Combination Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05252429
- Acronym / sponsor ID
- 020-011
- Conditions
- Effect of Drug
- Keywords
- head and neck cancer, docetaxel, pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Hokkaido University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pembrolizumab monotherapy and platinum-based chemotherapy in the combination with pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have been widely used in daily clinical practice based on the KEYNOTE-048 study. On the other hand, docetaxel is a commonly used antimitotic agent in cancer therapy and might have potent antitumor effect by the immune response. A combination therapy of docetaxel and pembrolizumab might be a promising treatment for R/M HNSCC. The KEYNOTE-048 study showed that pembrolizumab plus platinum and 5-fluorouracil is a tolerable treatment for R/M HNSCC. The main grade 3/4 adverse event of platinum and 5-fluorouracil was myelosuppression such as neutropenia similar to docetaxel in some studies for R/M HNSCC. The safety profile of platinum and 5-fluorouracil is not much different from docetaxel. Therefore, docetaxel/pembrolizumab combination treatment might also be tolerable. The hypothesis of this study is that a combination therapy of docetaxel and pembrolizumab will provide benefit for patients with R/M HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel plus pembrolizumab | Experimental | Drug: Docetaxel, Drug: PembrolizumabDocetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression or up to 35 cycles. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies.
- Subjects should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
- The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Subjects may not have a primary tumor site of nasopharynx (any histology).
- Be willing and able to provide written informed consent for the trial.
- Have results from testing of PD-L1 status.
Key exclusion criteria (12 listed)
- Has disease that is suitable for local therapy administered with curative intent.
- Has a life expectancy of less than 3 months and/ or has rapidly progressing disease in the opinion of the treating investigator.
- Has received prior systemic anti-cancer therapy including radiation therapy, other non-systemic therapy or investigational agents within 4 weeks prior to the first dose of trial treatment.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy, or used an investigational device, any of which occurred within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (using prednisolone ≥ 10mg per day) or any other form of immunosuppressive therapy within 7 days prior to the first dos e of trial treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel 75mg/m2; q21 | Drug | Docetaxel plus pembrolizumab |
| PembrolizumabAlso: KeytrudaPembrolizumab 200mg, q21 | Drug | Docetaxel plus pembrolizumab |
Primary outcome
Overall response rate (ORR)
Time frame: 1 year
Overall response rate is estimated per RECIST 1.1 by blinded independent central review (BICR).
4 secondary outcomes
Overall survival (OS)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Duration of response (DoR)
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From treatment start date to 30 days after the final administration of the study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Effect of Drug
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasushi Shimizu principal investigator
Hokkaido University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Pembrolizumab in people with Effect of Drug, run by Hokkaido University Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.