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Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.

NCT07633613 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-06-08

No results posted yet for this study

Summary

This is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative local treatment.

Conditions

  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Blood sampling

Patients will be followed according to standard clinical care. Biological samples collected include: (1) pharmacokinetic and extracellular vesicle analyses: 10 mL blood samples in EDTA tubes at 21±3, 35±3, 49±3, and 63±3 days after the last pembrolizumab administration (P1-P4); (2) pharmacogenetic analysis: one baseline 5 mL EDTA blood sample; (3) cytokine and immune cell analyses: at P1 and P4, collection of 2×4 mL lithium heparin tubes, 1×10 mL EDTA tube, and 1×5 mL dry tube.

PROCEDURE

Tumor biopsies for biobank establishment (optional)

Depending on feasibility of the procedure, and at the discretion of the investigator, two biopsies will be performed in 20 consenting patients: * Biopsy B1: between the last administration of pembrolizumab (Day 0) and before initiation of standard salvage chemotherapy, * Biopsy B2: after initiation of salvage chemotherapy, at Day 63 ± 7 days after the last administration of pembrolizumab. If chemotherapy is discontinued prematurely, Biopsy B2 may only be performed if the patient has received at least 3 weeks of chemotherapy exposure. Due to logistical constraints, these biopsies will be proposed to patients followed at CAL. They will be performed primarily in the interventional radiology department of CAL.

Sponsors & Collaborators

  • Centre Antoine Lacassagne

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633613 on ClinicalTrials.gov