Squamous Cell Carcinoma of Head and NeckPhase 2REDUCENCT06557889
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
A Phase 2 study testing Pembrolizumab + Cisplatin/Carboplatin + 5-FU in people with Squamous Cell Carcinoma of Head and Neck, run by Institut Claudius Regaud at 13 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Pembrolizumab + Cisplatin/Carboplatin + 5-FU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 13 sitesFrance
- Study dates
- 21 Oct 2024to Apr 2033
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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. Subjects 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.
Show all 19Show fewer
- 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 the investigator. Tumor lesions located in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Note : In case of neck MRI assessment, the chest, abdominal, and pelvic CT scan must be performed in addition to assess potential metastases.
- 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 are not required to perform HPV testing by p16 IHC because, by convention, these tumor locations are assumed to be HPV negative.
- Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.
- Female subjects 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 pembrolizumab, 6 months for carboplatin and 5-fluorouracil, and 7,5 months for cisplatin after the last dose of study treatment respectively for each molecule. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months.
- Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.
- Male subjects 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 lifestyle and preferred method of contraception.
- 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
Who cannot join
- 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 5-FU due to partial DPD deficiency); the investigator must refer to the SmPC of the products used in this trial (carboplatin, cisplatin, 5-fluorouracil, and pembrolizumab).
- 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.
Show all 32Show fewer
- Subject has not fully recovered (i.e. ≤ Grade 1) from adverse events due to previously administered treatment.
- Note: Subjects with neuropathy ≤ Grade 2, alopecia ≤ Grade 2, or laboratory values not exceeding the limits in Table 1 (See the protocol) are an exception to this criterion and may be eligible for the study Note: If the subject has undergone major surgery, they must have adequately recovered from the toxicity and/or complications of the procedure before starting treatment.
- 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: Participation in the follow-up phase of a previous study is permitted (if the patient is no longer receiving treatment in that study).
- 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 treatment. The use of corticosteroids as premedication for allergic reactions (e.g., IV contrast) or as prophylactic management of adverse events related to protocol-specified chemotherapies is permitted.
- 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 the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer.
- Note: The 5 year period does not apply to the cancer for which the subject is enrolled in the trial.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Note: Subjects with previously treated brain metastases may participate provided they have been stable (without evidence of progression by imaging using the same imaging modality for each assessment, either MRI or CT) for at least 4 weeks prior to the first dose of trial treatment, and without neurological symptoms, have no signs of new or progressing brain metastases, and are not using steroids > 10mg/day of prednisone equivalent for at least 7 days before study inclusion. This exception does not include carcinomatous meningitis which is excluded regardless of the clinical situation.
- 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 physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- 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 not in the best interest of the subject to participate, in the opinion of the investigator.
- 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 5-fluorouracil, and 7,5 months for cisplatin after the last dose of study treatment respectively for each molecule.
- 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 weeks before or after 5-FU).
- 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)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Amiens
Amiens
Institut Sainte Catherine
Avignon
Chu Bordeaux - Hopital Saint André
Bordeaux
Centre Jean Perrin
Clermont-Ferrand
Chu Limoges
Limoges
Centre Hospitalier Regional de Marseille
Marseille
CHU de Nantes
Nantes
Centre Antoine Lacassagne
Nice
Chu de Nimes
Nîmes
CHU Poitiers
Poitiers
Centre Eugène Marquis
Rennes
Clinique Pasteur
Toulouse
IUCT-O
Toulouse
About this study
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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Pembrolizumab + Cisplatin/Carboplatin + 5-FU
- Keywords
- Squamous Cell Carcinoma of Head and Neck, Pembrolizumab, Cisplatin, Carboplatin, 5-fluorouracil
- 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 + Cisplatin/Carboplatin + 5-FUDrug
- 4 cycles of combination treatment: 4 cycles of pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) in combination with chemotherapy with platinum salts (cisplatin (100 mg/m2 IV on Day 1 of each 3-week cycle) or carboplatin (AUC 5 IV on Day 1 of each 3-week cycle), at the investigator's choice) and 5-FU (1000 mg/m2/day IV continuous from Day 1-4 of each 3-week cycle).
- Maintenance phase: pembrolizumab is continued as monotherapy for up to 24 months of treatment in total (from the first injection of cycle 1).
| Study group | Role | What they receive |
|---|---|---|
| Patient with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck | Experimental | Not described Receives: Drug: Pembrolizumab + Cisplatin/Carboplatin + 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endpoint for the activity is defined by the objective response (i.e. complete or partial response) according to the RECIST v1.1 criteria, assessed by the investigator.
The objective response rate is defined as the ratio of the number of patients with an objective response to the total number of patients.
Measured: 48 months for each patient
The endpoint for the safety is defined as the rate of patients with AE leading to all treatment discontinuation.
This rate is defined as the ratio of the number of patients with AE leading to all treatment discontinuation to the total number of patients.
Measured: 24 months for each patient
Secondary outcomes (5)
The objective response rate at 6 months is defined by the presence of an objective response (i.e. complete or partial response) at 6 months according to the RECIST v1.1 criteria, assessed by the investigator.
It is defined by the ratio of the number of patients presenting an objective response at 6 months to the total number of patients.
Measured: 6 months for each patient
Progression-free survival is defined by the time between the date of inclusion and the date on which a first tumor confirmed progression is documented (according to RECIST v1.1 criteria, (Eisenhauer, 2009)) or death from any causes.
Patients alive and progression free on the date of last news will be censored on the date of last tumor assessment.
Measured: 48 months for each patient
Overall survival is defined by the time between the date of inclusion and the date of death from any cause or the date of the last news (Censored Data).
Measured: 48 months for each patient
Duration of response is defined in the population of patients with an objective response.
It is defined by the time between the date of confirmed objective response and the date on which a first confirmed tumor progression is documented (according to RECIST v1.1 criteria, Eisenhauer, 2009) or death from all causes. Patients alive and progression free at last news will be censored on the date of last tumor assessment.
Measured: 48 months for each patient
Safety will be assessed according to the toxicity grading of NCI CTCAE v 5.0.
Measured: 48 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start21 Oct 2024
- Primary completionApr 2033 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557889
- Sponsor's protocol ID
- 24VADS04
- Acronym
- REDUCE
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- REDUCE / 24VADS04
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Squamous Cell Carcinoma of Head and Neck, Pembrolizumab, Cisplatin, Carboplatin, 5-fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Apr 2033 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 16 Aug 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck | Experimental | Drug: Pembrolizumab + Cisplatin/Carboplatin + 5-FU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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. Subjects cannot have a primary tumor site (any histology) in the nasopharynx, sinuses, nasal cavity, salivary glands, or skin.
Key exclusion criteria (32 listed)
- 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 5-FU due to partial DPD deficiency); the investigator must refer to the SmPC of the products used in this trial (carboplatin, cisplatin, 5-fluorouracil, and pembrolizumab).
- The patient must not have received antibiotics within 14 days before inclusion in the trial.
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 |
|---|---|---|
| Pembrolizumab + Cisplatin/Carboplatin + 5-FU* 4 cycles of combination treatment: 4 cycles of pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) in combination with chemotherapy with platinum salts (cisplatin (100 mg/m2 IV on Day 1 of each 3-week cycle) or carboplatin (AUC 5 IV on Day 1 of each 3-week cycle), at the investigator's choice) and 5-FU (1000 mg/m2/day IV continuous from Day 1-4 of each 3-week cycle). * Maintenance phase: pembrolizumab is continued as monotherapy for up to 24 months of treatment in total (from the first injection of cycle 1). | Drug | Patient with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck |
Primary outcome
The endpoint for the activity is defined by the objective response (i.e. complete or partial response) according to the RECIST v1.1 criteria, assessed by the investigator.
Time frame: 48 months for each patient
The objective response rate is defined as the ratio of the number of patients with an objective response to the total number of patients.
The endpoint for the safety is defined as the rate of patients with AE leading to all treatment discontinuation.
Time frame: 24 months for each patient
This rate is defined as the ratio of the number of patients with AE leading to all treatment discontinuation to the total number of patients.
5 secondary outcomes
The objective response rate at 6 months is defined by the presence of an objective response (i.e. complete or partial response) at 6 months according to the RECIST v1.1 criteria, assessed by the investigator.
Time frame: 6 months for each patient
Progression-free survival is defined by the time between the date of inclusion and the date on which a first tumor confirmed progression is documented (according to RECIST v1.1 criteria, (Eisenhauer, 2009)) or death from any causes.
Time frame: 48 months for each patient
Overall survival is defined by the time between the date of inclusion and the date of death from any cause or the date of the last news (Censored Data).
Time frame: 48 months for each patient
Duration of response is defined in the population of patients with an objective response.
Time frame: 48 months for each patient
Safety will be assessed according to the toxicity grading of NCI CTCAE v 5.0.
Time frame: 48 months for each patient
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 11 Sep 2026.
Related trials for Squamous Cell Carcinoma of Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab + Cisplatin/Carboplatin + 5-FU in people with Squamous Cell Carcinoma of Head and Neck, run by Institut Claudius Regaud at 13 sites in France.
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 19 inclusion and 32 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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?
The endpoint for the activity is defined by the objective response (i.e. complete or partial response) according to the RECIST v1.1 criteria, assessed by the investigator. (time frame: 48 months for each patient). The study lists 2 primary outcomes in all. 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 11 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.