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)