Randomized phase III trial of radiation therapy with or without pembrolizumab for women with high intermediate risk mismatch repair deficient endometrioid endometrial cancer (NRG-GY020)

Rákkutatás · Endometrial cancer

Randomized phase III trial of radiation therapy with or without pembrolizumab for women with high intermediate risk mismatch repair deficient (dMMR) endometrioid endometrial cancer (NRG-GY020)

This multicenter, randomized phase‑III trial evaluates the addition of pembrolizumab to adjuvant radiation therapy in women with newly diagnosed early‑stage high‑intermediate risk mismatch‑repair deficient (dMMR) endometrioid endometrial cancer. The primary objective is to determine whether pembrolizumab improves 3‑year recurrence‑free survival (RFS). NRG‑GY020 is the first molecularly selected adjuvant therapy trial in endometrial cancer.

The study addresses the unmet need for targeted adjuvant therapy in dMMR endometrial cancer, a subset that constitutes ~25 % of endometrial cancers and historically lacks clear benefit from conventional chemoradiotherapy. Demonstrating improved RFS with the addition of a PD‑L1 inhibitor could establish a new standard of care for this high‑risk molecular subtype.

Bizonyítékszint: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.

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