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Head and Neck Squamous Cell CarcinomaPhase 2NCT06694350

Pembrolizumab in Combination with Flutamide Treatment for Recurrence / Metastasis HNSCC

A Phase 2 study testing Pembrolizumab+Flutamide in people with Head and Neck Squamous Cell Carcinoma, run by Zhejiang Provincial People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a single center, single arm clinical trial for newly diagnosed patients with locally advanced head and neck squamous cell carcinoma. The main purpose is to evaluate the efficacy and safety of flutamide combined with standard immunotherapy for advanced / recurrent head and neck squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Pembrolizumab+Flutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
Dec 2024to Dec 2027
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 18 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old, ≤ 85 years old
  • Histologically or cytologically proven squamous cell carcinoma of the head and neck; Patients diagnosed with head and neck squamous cell carcinoma with stage III and IV A without distant metastasis according to AJCC staging (8th editon), including squamous cell carcinoma of oropharyngeal (P16-), oral cavity, hypopharyngeal and larynx
  • Measurable primary lesions per RECIST 1.1 criteria
  • Treatment-naive patients without any previous disease-related therapy (except for diagnostic biopsies on primary lesions)
  • ECOG performance status of 0 or 1
  • Unresectable primary, recurrent, and / or metastatic HNSCC
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  • No active autoimmune disease
  • No concurrent malignancy
  • Life expectancy is estimated to be over 3 months
  • Have sufficient tumour tissue samples available for CPS PD-L1 immunohistochemical examination (22C3 DAKO)
  • No abvious signs of hematological disorders, ANC≥1.5×109 /L, platelets ≥100×109 /L, Hb≥ 90 g/L,WBC ≥3.0×109 /L before enrollment, no blood transfusion and bleeding tendency within 7 days
  • ALT,AST and ALP ≤ 2.5 × upper limit of normal (ULN); Serum bilirubin ≤ 1.5 × ULN, for patients with known Gilbert disease, serum bilirubin ≤ 3 x ULN
  • Serum creatinine ≤1.5 or creatinine clearance>50 mL/min
  • HPV status determined by p16 IHC, in situ hybridization, or by polymerase chain reaction-based assays
  • Able to understand this study, patient and (or) legal representative voluntarily agree to participate in this trial and sign informed consent

Who cannot join

  • Patients who are suitable for local treatment and have the intention of local treatment
  • Received systemic treatment with Chinese patent drugs with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within 2 weeks before the first administration
  • Patients with tumor progression after previous treatment with flutamide analogues (antiandrogens)
  • Other malignant tumors occurred within 5 years or suffered from at the same time in the current period, except for cured non melanoma skin cancer or other tumors / cancers that have undergone radical treatment and have no signs of disease for at least 5 years;
  • According to the criteria of common adverse event terminology (NCI ctcaev5.0), there was peripheral neuropathy ≥ grade 2
  • With known active central nervous system metastasis (CNS) and / or cancerous meningitis
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  • Subjects who did not recover from any acute effects of previous surgery, chemotherapy or radiotherapy, i.e. did not fall to grade ≤ 1 (NCI ctcaev5.0) (excluding hair loss). Chronic late toxicity from previous radiotherapy and / or surgery is allowed if nutritional status is stable
  • Any component of the study drug or preparation has led to severe allergic reactions, including known severe allergic reactions to flutamide and (NCI ctcaev5.0 ≥ grade 3)
  • Have received anti-tumor drug treatment (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) within 4 weeks or 4 weeks before the first administration, except for palliative radiotherapy for bone to reduce pain
  • Major surgery within 4 weeks before the first dose or expected during this study
  • Immunosuppressive drugs were required 2 weeks or within 2 weeks before the first dose or during the study
  • Subjects who are known to have active, or have a history of autoimmune disease that may recur
  • Subjects with known history of interstitial lung disease, non infectious pneumonia, or high suspicion of interstitial lung disease
  • Hepatitis B or C virological examination meets any of the following requirements at the time of screening:
  • HBsAg is positive, and the titer of hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood is ≥ 104 copies /ml or ≥ 2000 iu/ml;
  • HCV antibody was positive, and HCV-RNA was higher than the detection limit of the analytical method;
  • Within 2 weeks or 2 weeks before the first administration, the subject had active infection or uncontrollable infection requiring systemic treatment (except simple urinary tract infection or upper respiratory tract infection)
  • Serous cavity effusion with clinical symptoms requiring clinical intervention or stabilization time less than 4 weeks
  • Diabetes mellitus (fasting blood glucose ≥ 10mmol/l) or hypertension (systolic blood pressure ≥ 160mmhg and / or diastolic blood pressure ≥ 100mmhg) with severe medical diseases, such as grade III or above cardiac dysfunction (New York Heart Association [nyha]), ischemic heart disease (such as myocardial infarction or angina pectoris) and other cardiovascular diseases, or a history of myocardial infarction within 3 months before the first administration, and still poorly controlled after drug treatment (fasting blood glucose ≥ 10mmol/l) or poorly controlled hypertension (systolic blood pressure ≥ 160mmhg and / or diastolic blood pressure ≥ 100mmhg)
  • Medical or psychiatric history or history of laboratory abnormalities that may interfere with the interpretation of the results
  • Subjects are currently enrolled in the study of other investigational devices or investigational drugs, or are less than or equal to 4 weeks away from the discontinuation of other investigational drugs or investigational devices
  • Subjects were known to have alcohol or drug addiction
  • Subjects have other conditions that may affect their compliance with the protocol and evaluation of research indicators, and are not suitable to participate in the study

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ge Minghua, Doctor contact

+86 13605813782

gemingh@163.com

About this study

Official title: Safety and Efficacy of Pembrolizumab in Combination with Flutamide Treatment for Advanced/Recurrence / Metastasis Head and Neck Squamous Cell Carcinoma: a Single-arm Clinical Study Trial

This study is a single center, single arm clinical trial for newly diagnosed patients with locally advanced head and neck squamous cell carcinoma. The main purpose is to evaluate the efficacy and safety of flutamide combined with standard immunotherapy for advanced / recurrent head and neck squamous cell carcinoma.

In our previous study, we found that AR can affect the occurrence and development of tumors by regulating the differentiation of cd8+t cells. We used three different castration drugs (flutamide, goserelin and abiraterone) in animal models to treat primary and tumor bearing head and neck squamous cell carcinoma mice respectively, and found that castration treatment could significantly inhibit the tumor growth of head and neck squamous cell carcinoma. In addition, in animal models, we compared the efficacy of the combination of castration therapy and low-dose cisplatin with that of the existing first-line chemotherapy drug cisplatin, and found that the combination of castration therapy and low-dose cisplatin can significantly improve the treatment effect of head and neck squamous cell carcinoma and reduce the adverse reactions brought by the drug. Therefore, we infer that flutamide combined with standard immunotherapy can fully inhibit the growth of HNSCC and improve the prognosis of HNSCC patients.

Being tested
Pembrolizumab+Flutamide
Keywords
HNSCC
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab+FlutamideDrug

    Pembrolizumab 200mg ivgtt once +Flutamide 250mg，Q8h

Study groups in NCT06694350
Study groupRoleWhat they receive
Pembrolizumab+FlutamideExperimentalPembrolizumab 200mg ivgtt once +Flutamide 250mg，Q8h
Receives: Drug: Pembrolizumab+Flutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    The Progression-Free-Survival of Interventions group

    Measured: Up to 4 years

Secondary outcomes (3)

  1. ORR

    The Objective Response Rate of Intervention group

    Measured: Up to 4 years

  2. DOR

    The Disease Control Rate of intervention group

    Measured: Up to 4 years

  3. OS

    The overall survival of paticipated patients

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study startDec 2024 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06694350
Sponsor's protocol ID
KF20240822
Status last verified
Nov 2024
First submitted
31 Oct 2024
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab+Flutamide in people with Head and Neck Squamous Cell Carcinoma, run by Zhejiang Provincial People's Hospital.

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 15 inclusion and 23 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: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Ge Minghua, Doctor (+86 13605813782, gemingh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06694350.

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 19 Nov 2024.

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