PRIMMO Study Protocol: A Phase II Study Combining PD-1 Blockade, Radiation and Immunomodulation to Tackle Cervical and Uterine Cancer
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PRIMMO Study Protocol: A Phase II Study Combining PD-1 Blockade, Radiation and Immunomodulation to Tackle Cervical and Uterine Cancer

Publication
Sandra Tuyaerts, An M T Van Nuffel, Eline Naert, Peter A Van Dam, Peter Vuylsteke, Alex De Caluwé, Sandrine Aspeslagh, Piet Dirix, Lien Lippens, Emiel De Jaeghere, Frédéric Amant, Katrien Vandecasteele, Hannelore Denys (2019) PRIMMO Study Protocol: A Phase II Study Combining PD-1 Blockade, Radiation and Immunomodulation to Tackle Cervical and Uterine Cancer BMC Cancer 28;19(1):506. doi: 10.1186/s12885-019-5676-3.

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.

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