CRO Pivotal inks investigator-sponsored trial deal for genitourinary cancers

The Spain-headquartered contract research organisation (CRO) Pivotal has teamed with APRO (Associació Per la Recerca Oncológica) to assess investigational cancer treatments in combination with chemotherapy in three investigator-sponsored trials (ISTs).

The medium-sized CRO and APRO – a non-profit association that aims to advance cancer research – will study two novel drugs in two separate bladder cancer trials and one prostate cancer study.

According to Pivotal, “Both drugs, a checkpoint inhibitor and a targeted therapy blocking mTOR pathway, will be combined with chemotherapy, aiming to confirm the hypothesis of a synergistic mechanism of action and, specifically for the immunotherapy drug, an induced treatment-related auto-vaccination.” ​

The partnership is a boon for ‘ethical’ independent research studies, said APRO principal investigator Joaquim Bellmunt in a statement​: “Investigator sponsored trials expand product knowledge and search for new ways to use existing treatments, thus improving the health of many patients​.”

“We truly believe in the need for ethical independent clinical research conducted by qualified cooperative groups and investigators in order to complement Pharma-sponsored research and ensure a better understanding of the benefit/risk profile of current therapies, as well as to explore new opportunities to address unmet medical needs,​” he added.