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This combination therapy, often referred to as the GCP + nivolumab protocol, is an investigational treatment regimen developed by the Centre Hospitalier Universitaire, Amiens. It involves the 24-hour intratumoral infusion of a chemotherapy triplet—gemcitabine, carboplatin, and paclitaxel—delivered via catheter, followed by systemic intravenous administration of the PD-1 inhibitor nivolumab. The protocol is specifically being evaluated in Phase 2 clinical trials for patients with locally recurrent squamous cell carcinoma of the head and neck (SCCHN) who have failed or had an insufficient response to prior immunotherapy. The therapeutic strategy aims to utilize the cytotoxic effects of the intratumoral chemotherapy to induce immunogenic cell death and release tumor antigens, thereby "priming" the tumor microenvironment and potentially resensitizing the cancer to the immune-checkpoint blockade provided by nivolumab. Gemcitabine acts as a nucleoside analog, carboplatin as a DNA alkylating agent, and paclitaxel as a microtubule stabilizer, while nivolumab blocks the PD-1/PD-L1 pathway to restore T-cell activity.
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