Actively Recruiting
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
Led by Institut Claudius Regaud · Updated on 2026-02-11
86
Participants Needed
14
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on the day of signing informed consent
- Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck not suitable for curative treatment
- No prior systemic therapy for recurrent or metastatic disease
- If prior platinum-based chemotherapy was given for locally advanced disease, it ended at least 6 months before consent
- Primary tumor located in oropharynx, oral cavity, hypopharynx, or larynx (nasopharynx, sinuses, nasal cavity, salivary glands, or skin tumors excluded)
- Documented Combined Positive Score (CPS) PD-L1 of 1 or greater
- Measurable disease by CT or MRI according to RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate organ function per protocol
- HPV test results available for oropharyngeal cancers
- Negative pregnancy test for females of childbearing potential within 72 hours before treatment
- Agreement to use contraception or abstain from heterosexual activity during study and specified periods after treatment
- Signed informed consent
- Ability and willingness to comply with study procedures
- Affiliated with French social health insurance
You will not qualify if you...
- Disease that can be treated with curative intent by local therapy
- Disease progression within 6 months after curative platinum-based treatment
- Complete DPD enzyme deficiency
- Contraindication to full doses of platinum, 5-FU, or pembrolizumab
- Antibiotic use within 14 days before study entry
- Radiotherapy or non-systemic therapy within 2 weeks before inclusion
- Not fully recovered from prior treatment adverse events (exceptions apply)
- Participation in other investigational studies within 4 weeks before first dose
- Life expectancy less than 3 months or rapidly progressing illness
- Immunodeficiency or systemic corticosteroid/immunosuppressive therapy within 7 days before treatment
- Second cancer treated or diagnosed within 5 years (exceptions apply)
- Active CNS metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of organ or hematopoietic allograft
- History of non-infectious pneumonia requiring corticosteroids
- Active infection needing systemic treatment
- Any condition interfering with study participation or results
- Pregnancy, breastfeeding, or planning to conceive during study and specified follow-up periods
- Previous treatment with anti-PD-1 or anti-PD-L1 agents for this cancer
- Known HIV infection
- Known active hepatitis B or C
- Live vaccine within 30 days before study
- Known hypersensitivity to study drugs or excipients
- Specific cardiac, neurological, or drug interaction contraindications according to treatment received
- Psychological, social, or legal conditions preventing informed consent or protocol compliance
- Legal protection status restricting consent or freedom of the patient
AI-Screening
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Trial Site Locations
Total: 14 locations
1
CHU Amiens
Amiens, France
Actively Recruiting
2
Institut Sainte Catherine
Avignon, France
Not Yet Recruiting
3
Chu Bordeaux - Hopital Saint André
Bordeaux, France
Actively Recruiting
4
Centre Jean Perrin
Clermont-Ferrand, France
Not Yet Recruiting
5
Centre Oscar Lambret
Lille, France
Not Yet Recruiting
6
Chu Limoges
Limoges, France
Actively Recruiting
7
Centre Hospitalier Regional de Marseille
Marseille, France
Actively Recruiting
8
CHU de Nantes
Nantes, France
Not Yet Recruiting
9
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
10
Chu de Nimes
Nîmes, France
Actively Recruiting
11
CHU Poitiers
Poitiers, France
Actively Recruiting
12
Centre Eugène Marquis
Rennes, France
Not Yet Recruiting
13
Clinique Pasteur
Toulouse, France
Actively Recruiting
14
IUCT-O
Toulouse, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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