RecruitingPhase 2NCT06557889

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


Sponsor

Institut Claudius Regaud

Enrollment

86 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

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 recurrent or metastatic head and neck squamous cell carcinoma. A total of 86 patients will have to be enrolled in this study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether reducing the number of chemotherapy cycles given alongside pembrolizumab (an immunotherapy) is just as effective as the standard number of cycles for treating head and neck squamous cell carcinoma (cancer of the mouth, throat, or voice box) that has returned or spread. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the oropharynx, oral cavity, hypopharynx, or larynx - You have not received prior chemotherapy for metastatic or recurrent disease - Your tumor tests positive for PD-L1 (a marker that makes immunotherapy more likely to work) - You have measurable disease on CT or MRI scan **You may NOT be eligible if...** - You have cancer originating in the nasopharynx, sinuses, salivary glands, or skin - You previously received chemotherapy for metastatic disease - Your prior platinum chemotherapy for locally advanced disease ended less than 6 months ago - You have active autoimmune disease or are taking systemic steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab + 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).


Locations(14)

CHU Amiens

Amiens, France

Institut Sainte Catherine

Avignon, France

Chu Bordeaux - Hopital Saint André

Bordeaux, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Oscar Lambret

Lille, France

Chu Limoges

Limoges, France

Centre Hospitalier Regional de Marseille

Marseille, France

CHU de Nantes

Nantes, France

Centre Antoine Lacassagne

Nice, France

Chu de Nimes

Nîmes, France

CHU Poitiers

Poitiers, France

Centre Eugène Marquis

Rennes, France

Clinique Pasteur

Toulouse, France

IUCT-O

Toulouse, France

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NCT06557889


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