PIVOTAL and APRO partner to develop three Investigator Sponsored Trials in Genitourinary tumours

PRO has joined the list of cooperative groups to forge strategic deals with Contract Research Organisations (CROs) by working closely with PIVOTAL in the execution of these development programmes to study two new drugs, tested in two different bladder cancer trials and one prostate cancer trial.

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 autovaccination. 

"The power of this partnership between APRO and PIVOTAL is to bring together the best minds and capabilities of both parties to accelerate this dynamic and exciting area of research based on Investigator Sponsored Trials," said Dr. Sonia Maciá, Medical Director Oncology at PIVOTAL. 

APRO has considered PIVOTAL as a preferred partner for these three ISTs. PIVOTAL's expertise as a European CRO and its deep knowledge of the European landscape will facilitate rapid patient enrollment into these trials across selected sites and will help them increase operational efficiency, redefining collaboration with comprehensive medical advice and support. 

"Investigator Sponsored Trials expand product knowledge and search for new ways to use existing treatments, thus improving the health of many patients," said Dr. Bellmunt, APRO´s head and the trials´ Principal Investigator. "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."

The first study is a phase II clinical trial enrolling unfit bladder cancer patients, combining chemotherapy plus an anti-PD-L1. This study is particularly interesting since there are a lack of trials in unfit patients, and combining immune checkpoint inhibitors and chemotherapy might be a valid strategy to boost efficacy while overcoming treatment resistance. It will further provide insight in the potential molecular biomarkers of response and resistance to better select the best candidates for immune checkpoint blockade in urothelial cancer. 

The second study will also test a combination with chemotherapy and an anti-PD-L1 in prostate cancer patients, progressing after at least one line of chemotherapy and one line of new agents targeting the androgen receptor signaling axis. This will be a phase Ib study to test safety and tolerability of the combination strategy and will use a modified CRF designed to assess response criteria through RECIST, iRECIST and PCWG3 criteria.

The third study will test a combination of an innovative targeted therapy with chemotherapy in second or further lines in patients with bladder cancer. There is a lack of treatment options (apart from immunotherapy) for patients in this situation and therefore, this is considered an unmet medical need. 

All three studies will be enriched by exploratory endpoints including predictive biomarkers of response and resistance. 
 
About PIVOTAL
PIVOTAL was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognised the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the "doers" but also as the "co-thinkers" for their clients, through its strategic scientific advice. To date, we are the trusted advisor and counselor for many companies to deliver maximum value in their drug development programmes. We are a leading privately-held European CRO and, since inception, we have experienced a fast and steady organic growth in Europe.

PIVOTAL's client portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, as well as independent investigators and cooperative groups. We have long-standing relations with over 188 clients. PIVOTAL has extensive experience across major therapeutic areas and phases I to IV. Our highly customised teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights. Additionally, we have built a strong oncology, innovative therapies, rare diseases and early phases hub that enables us to tackle our customers' most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our client's preferred outsourcing solution partner.

For more information, please visit www.pivotal.es

About APRO
APRO (Associació Per la Recerca Oncológica) is a cooperative group focused on the treatment of genitourinary tumors, whose president, Dr. Joaquim Bellmunt, is strongly committed to the research and development of new treatments. Dr. Bellmunt is involved in the clinical development of new agents and combinations. His areas of interest in genitourinary oncology include the development of drugs directed to novel therapeutic targets and early clinical and translational research in the field of immunotherapy, factor receptors and angiogenesis. He has directed several multicentre international trials of immunotherapy in the treatment of prostate, kidney and bladder cancer.

For more information, please visit  www.apro.org.es