Clinical trials

This is a randomized, open-label, active-comparator-controlled, multi-regional, three-arm, phase 3 study comparing the efficacy and safety of ivonescimab in combination with ligufalimab to pembrolizumab and of ivonescimab alone to pembrolizumab as first-line treatment in patients with recurrent or metastatic (R/M) PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). The objective of this study is to improve first-line survival in patients with recurrent or metastatic PD-L1-positive HNSCC (CPS ≥ 1). Overall survival (OS) was chosen as the primary endpoint. Patients will receive the following treatment regimens in accordance with the study treatment plan until disease progression, death, intolerable toxicity, or the occurrence of another protocol-specified treatment discontinuation criterion, whichever occurs first. * ARM A: Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W) * ARM B: Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W), and ligufalimab (45 mg/kg iv, 120 min ± 15 min infusion, Q3W). * ARM C (control arm): Pembrolizumab (200 mg iv, 60 min ± 10 min infusion, Q3W). The total duration of treatment is up to 24 months

This is a multicenter study comprising two phases: a run-in phase, including only patients receiving ficerafusp alfa and nivolumab, and a randomized phase, which corresponds to a randomized, open-label, phase II comparative study. The primary objective is to compare the objective response rate (ORR) of patients with platinum refractory HNSCC with progressive disease within the 6 months after multimodal curative treatment treated with ficerafusp alfa (BCA 101) and nivolumab versus nivolumab alone. There is a strong medical justification for combining ficerafusp alfa with nivolumab (anti-PD-1) to provide additional clinical benefit to patients with platinum-refractory HNSCC who are progressing within 6 months of multimodal treatment for locally advanced disease. In the Run-in phase, patients will receive the following treatment regimens according to the study intervention plan: Combination of Ficerafusp alfa + Nivolumab * Ficerafusp alfa 1500 mg every week * Nivolumab 240 mg every 2 weeks In the randomized trial: * ARM A Combination of Ficerafusp alfa + Nivolumab Ficerafusp alfa 1500 mg every week Nivolumab 240 mg every 2 weeks * ARM B Nivolumab monotherapy Nivolumab 240 mg every 2 weeks

The primary objective of this study is to compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti PD-1 Pucotenlimab versus EGFR-ADC MRG003 alone before chemoradiotherapy. People eligible to participate in this study must be between the ages of 18 and 75 and have locally advanced squamous cell carcinoma of the head and neck requiring treatment with chemoradiotherapy (cisplatin combined with radiotherapy). Half of the research participants will receive MRG003 alone as induction before radiochemotherapy and the other half will receive MRG003 combined with pucotenlimab as induction before radiochemotherapy, then pucotenlimab as adjuvant\* after radiochemotherapy.

The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment. All participants in this research will receive the same treatment which will take place in two phases: * 1st phase chemotherapy + immunotherapy: standard reference treatment (Docetaxel + cisplatin or carboplatin + cetuximab) * 2nd phase immunotherapy: cetuximab combined with avelumab which is the treatment under study.