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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Antoine Lacassagne

About this trial

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.

Eligibility criteria

Qualifiers

Non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma.

Head and neck squamous cell carcinoma, p16-negative for oropharyngeal tumors.

Recurrent and/or metastatic tumor not amenable to curative locoregional treatment.

For pulmonary squamous cell carcinomas: Gemcitabine monotherapy.

Disqualifiers

History of cancer, except for cancers in complete remission for more than 3 years, fully resected cutaneous basal cell carcinomas, or treated carcinoma in situ or cervical intraepithelial neoplasia (in situ cervical epithelioma),

Patients participating in another clinical trial for which an exclusion period is specified,

Minor patients,

Or Bivalirudin without the possibility of discontinuation 2-3 hours before the procedure if CrCL > 50 mL/min, or 3-5 hours if CrCL < 50 mL/min,

Trial design

Treatments tested in this trial

  • Blood sampling
  • Tumor biopsies for biobank establishment (optional)

Treatment groups

110 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators