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New treatment option for Squamous Cell Carcinoma of Head and Neck
Official title Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas
ClinicalTrials.gov ID: NCT06557889
What this study is testing
What is Pembrolizumab + Cisplatin/Carboplatin + 5-FU?
Pembrolizumab + Cisplatin/Carboplatin + 5-FU is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for squamous cell carcinoma of head and neck.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. A total of 86 patients will have to be enrolled in this study.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old on the day of signing the informed consent.
- Diagnosis of histologically proven recurrent or metastatic squamous cell carcinoma of the head and neck not accessible to treatment with curative...
- Patients must not have received previous systemic therapy administered in the context of recurrent or metastatic disease.
- If the patient received chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease, it must have ended at least 6...
- Eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx and larynx. people cannot have a primary tumor site (any histology) in...
You likely can't join if
- Has a disease accessible to local treatment with curative intent.
- Has a progressive disease within six months following the end of primary treatment with curative intent, if this treatment included systemic...
- Has a complete DPD enzyme deficiency, suggested by an uracilemia \> or equal to 150 ng/mL.
- Has a contraindication to full dose use of a platinum salt, 5-Fluorouracil, or pembrolizumab, in the opinion of the investigator (dose reductions in...
- The patient must not have received antibiotics within 14 days before inclusion in the trial.
- Received radiotherapy (or other non-systemic therapy) within 2 weeks prior to inclusion.
See the full eligibility criteria
Who can join
- Age ≥ 18 years old on the day of signing the informed consent.
- Diagnosis of histologically proven recurrent or metastatic squamous cell carcinoma of the head and neck not accessible to treatment with curative intent.
- Patients must not have received previous systemic therapy administered in the context of recurrent or metastatic disease.
- If the patient received chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease, it must have ended at least 6 months before signing the consent.
- Eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx and larynx. people cannot have a primary tumor site (any histology) in the nasopharynx, sinuses, nasal cavity, salivary glands, or skin.
- Documented Combined Positive Score (CPS) PD-L1 ≥ 1 (determined according to local practices in each center) Note: the CPS score can be performed on a new biopsy or on an archived tumor specimen, without date limitation.
- Have measurable disease on CT-scan (or on MRI of the neck if it provides a better measurement of the primary tumor according to standard practice and the investigator judgement) according to RECIST 1.1 as determined by...
- Have a performance status of 0 or 1 on the ECOG performance scale.
- Demonstrate adequate organ function as defined in the protocol.
- Have HPV status test results for oropharyngeal cancers defined as a p16 immunohistochemical (IHC) test (determined according to local practices in each center). Note: Cancers of the oral cavity, hypopharynx, and larynx...
- Female people of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.
- Female people of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 4 months for...
- Male people must agree to use at least one method of contraception for the duration of the study and until 180 days after the last dose of study treatment. Note: Abstinence is acceptable if it is the subject's usual...
- Signed written informed consent
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France
What rules you out
- Has a disease accessible to local treatment with curative intent.
- Has a progressive disease within six months following the end of primary treatment with curative intent, if this treatment included systemic treatment with platinum salt.
- Has a complete DPD enzyme deficiency, suggested by an uracilemia \> or equal to 150 ng/mL.
- Has a contraindication to full dose use of a platinum salt, 5-Fluorouracil, or pembrolizumab, in the opinion of the investigator (dose reductions in cycle 1 are not authorized, except in the case of adaptation of the...
- The patient must not have received antibiotics within 14 days before inclusion in the trial.
- Received radiotherapy (or other non-systemic therapy) within 2 weeks prior to inclusion.
- Subject has not fully recovered (i.e. ≤ Grade 1) from adverse events due to previously administered treatment. Note: people with neuropathy ≤ Grade 2, alopecia ≤ Grade 2, or laboratory values not exceeding the limits in...
- Currently participating in and receiving study treatment, or has participated in a study of an investigational agent, or used an investigational device, within 4 weeks prior to the first dose of treatment. Note...
- Has a life expectancy of less than 3 months and/or has a rapidly progressing illness (eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator.
- Has a diagnosis of immunodeficiency or is receiving systemic corticosteroid therapy \> 10 mg/day of prednisone equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of trial...
- Has a diagnosis of a second cancer diagnosed and/or treated within 5 years preceding inclusion, with the exception of: curatively resected basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of...
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: people with previously treated brain metastases may participate provided they have been stable (without evidence of...
- Active autoimmune disease that has required systemic treatment within the past 2 years (i.e. with the use of corticosteroids or immunosuppressive drugs). Replacement therapy (for example: thyroxine, insulin or...
- Has undergone solid tissue/organ allograft or hematopoietic allograft.
- Has a history of or has non-infectious pneumonia requiring corticosteroids.
- Has an active infection requiring systemic anti-infectious treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that could interfere with the results of the trial or with the subject's participation throughout the duration of the trial, or is...
- Is pregnant or breastfeeding, or expects to conceive or father children during the planned duration of the trial, beginning the screening visit through and until 4 months for pembrolizumab, 6 months for carboplatin and...
- Has previously received treatment with an anti-PD-1 or anti-PD-L1 agent for the treatment of the cancer for which the patient is included in the trial, whether as part of the primary treatment or as part of the relapse.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has known active hepatitis B or C.
- Received a live vaccine within 30 days before the planned start of study treatment.
- Has a known history of hypersensitivity to fluorouracil, carboplatin, cisplatin or pembrolizumab or to any of their excipients, according to the SmPCs of these products.
- For patient receiving the treatment with 5-fluorouracil: has clinically significant active heart disease or myocardial infarction within 6 months; has received a recent or has a concomitant treatment with brivudine (4...
- For patient receiving the treatment with cisplatin: has a neuropathy caused by cisplatin, has a hearing problem, has a treatment with phenytoin with prophylactic aim.
- For patient receiving the treatment with pembrolizumab: has a history of uncontrolled or symptomatic cardiac disease.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Avignon, France
- Bordeaux, France
- Clermont-Ferrand, France
- Lille, France
- Limoges, France
- Marseille, France
- Nantes, France
- Nice, France
- Nîmes, France
- Poitiers, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Avignon, France; Bordeaux, France; Clermont-Ferrand, France; Lille, France; Limoges, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.