PRIMMO Study Protocol: A Phase II Study Combining PD-1 Blockade, Radiation and Immunomodulation to Tackle Cervical and Uterine Cancer
Immunotherapeutic approaches have revolutionised oncological practice but in gynaecological malignancies PD-1/PD-L1 blockade monotherapy shows low objective responses (13-17% of patients).
Gynaecological tumours contain an immunosuppressive microenvironment and an altered tumour vasculature. In this study, named PRIMMO, a combination of PD-1 blockade, radiation and immune/environmental-modulating compounds (vitamin D, lansoprazole, aspirin, cyclophosphamide and curcumin) is tested, aiming to tackle the tumour microenvironment and induce anti-tumour immunity. Translational research is performed to discover biomarkers related to the mode of action of the combination.
The publication describes the protocol of this multi-center, open-label, non-randomised, 3-cohort phase 2 study with safety run-in in patients with recurrent/refractory cervical carcinoma, endometrial carcinoma or uterine sarcoma.
Read more about the PRIMMO trial here.