Imfinzi (durvalumab)

P2, N=100, Recruiting, Jeeyun Lee | N=50 --> 100

Given the refractory nature of his disease course, he was subsequently treated with a repeat dose of IVIG and prednisone, then transferred to an outside facility for plasma exchange. This case highlights the rare but potentially fatal concurrent occurrence of immune-related myasthenia gravis and myocarditis as irAEs in a patient receiving durvalumab for cholangiocarcinoma. While checkpoint inhibitors have revolutionized outcomes across many solid tumor malignancies, this case underscores the diagnostic and management challenges posed by severe, refractory irAEs, and the importance of early recognition and aggressive treatment in this patient population.

P2, N=30, Completed, National Taiwan University Hospital | Active, not recruiting --> Completed

P2, N=22, Not yet recruiting, University of Washington

Chemoimmunotherapy is the reference first-line regimen for biomarker-unselected advanced cholangiocarcinoma. Early comprehensive genomic profiling is essential to enable timely, matched targeted therapy and maximize population-level benefit.

Pretreatment intratumoral CD8+ TIL density was associated with an improved response and a longer PFS in STRIDE-treated HCC. Baseline tumor immune contexture may serve as a practical predictive biomarker for STRIDE. These findings are exploratory and hypothesis-generating, and require validation in larger prospective studies.

Durvalumab plus etoposide-platinum demonstrated a modest treatment response in neuroendocrine-transformed EGFR-mutated NSCLC. AEs were concordant with the known safety profiles of the combination, and no new safety signals were observed.

P3, N=570, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.

P3, N=214, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Sep 2026 | Trial primary completion date: Mar 2025 --> Sep 2026

Immunotherapy-related pneumonitis ≥grade 1 was documented in 15.7% patients. In real-world practice, durvalumab improves OS and PFS in PD-L1-positive unresectable stage III NSCLC and its omission appears particularly unfavourable.

These findings suggest that iSBRT + anti-PD-L1 may convert immune-cold ER+HER2- BC into more inflamed tumors and improve response, particularly in PD-L1-negative disease. ClinicalTrials.gov registration: NCT03875573 .

Sequential systemic chemotherapy including durvalumab is suggested as a useful future treatment option and may contribute to conversion surgery for unresectable ampulla of Vater carcinoma.