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

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

Publish date: 2018-07-04

PIVOTAL and APRO have today announced a close collaboration in three different oncology clinical trials to test new treatment strategies delivered in an innovative way. The three trials have been recently approved by the Competent Authorities and the corresponding Ethics Committees and have already enrolled their first patient as planned.

Tags: clinical trials , oncology , PIVOTAL , APRO

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 

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2018-09-11 18:22:01 +0200
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2018-09-10 07:43:16 +0200
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2018-09-03 09:46:52 +0200
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2018-08-31 09:13:51 +0200
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2018-08-29 13:56:02 +0200
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2018-08-28 22:10:32 +0200
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2018-08-26 09:28:34 +0200
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2018-08-15 09:22:16 +0200
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2018-08-15 00:06:21 +0200
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2018-08-11 07:40:03 +0200
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2018-08-10 06:05:34 +0200
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2018-08-09 18:02:04 +0200
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2018-08-02 14:29:51 +0200
Powerful Effective Love Spell Get Your Ex Back About a month ago I got back to my ex(after 2 and half years separated).Everything was ok and she was the most adorable woman in the world. she spoke about wedding ceremony, how many kids we would have, said that our relationship was the most important thing in her life and she was 100% sure about it…Then he traveled to work in other country for 3 weeks. she changed his behavior completely. she disappeared every night, was saying she had to do some work and would talk to me later, but disappeared the rest of the day and night… no explanation, when I asked why she was disappearing every night, she stopped answering me. she’s ignoring me since last week, April 15. she ignored even my birthday, that was April 16. Not even a message. I wrote to her a few times trying to understand what happened, she read but just ignored me.I feel so bad cause I couldn’t stop contacting and trying to understand what happened.i loved her so much and wanted to get her back, then i was told to contact happylovespell2@gmail.com who can help out with a love spell to reunite your relationship back, so instantly do contact him and give him a try and trust me he did an urgent effective love spell for me and with in 48hours promise he made to me, my woman was back, today i testify to you all that you should seek and contact Dr happy for his spell result is genuine sure and guarantee unite and get your ex back save your marriage/relationship problem now, You can also know more about his spell Blogs site.http://happylovespel.blogspot.com.ng/ Email him now on.. happlovespell2@gmail.com If you want to talk for more info or consultation. Whatsapp/cal +2348133873774 Assurance and spell guarantee, visit his website...happylovespell2.webnode.com/
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2018-07-30 00:20:48 +0200
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2018-07-12 21:24:11 +0200
Powerful Effective Love Spell Get Your Ex Back About a month ago I got back to my ex(after 2 and half years separated).Everything was ok and she was the most adorable woman in the world. she spoke about wedding ceremony, how many kids we would have, said that our relationship was the most important thing in her life and she was 100% sure about it…Then he traveled to work in other country for 3 weeks. she changed his behavior completely. she disappeared every night, was saying she had to do some work and would talk to me later, but disappeared the rest of the day and night… no explanation, when I asked why she was disappearing every night, she stopped answering me. she’s ignoring me since last week, April 15. she ignored even my birthday, that was April 16. Not even a message. I wrote to her a few times trying to understand what happened, she read but just ignored me.I feel so bad cause I couldn’t stop contacting and trying to understand what happened.i loved her so much and wanted to get her back, then i was told to contact happylovespell2@gmail.com who can help out with a love spell to reunite your relationship back, so instantly do contact him and give him a try and trust me he did an urgent effective love spell for me and with in 48hours promise he made to me, my woman was back, today i testify to you all that you should seek and contact Dr happy for his spell result is genuine sure and guarantee unite and get your ex back save your marriage/relationship problem now, You can also know more about his spell Blogs site.http://happylovespel.blogspot.com.ng/ Email him now on.. happlovespell2@gmail.com If you want to talk for more info or consultation. Whatsapp/cal +2348133873774 Assurance and spell guarantee, visit his website...happylovespell2.webnode.com/
Guest
2018-07-11 00:56:24 +0200
Powerful Effective Love Spell Get Your Ex Back About a month ago I got back to my ex(after 2 and half years separated).Everything was ok and she was the most adorable woman in the world. she spoke about wedding ceremony, how many kids we would have, said that our relationship was the most important thing in her life and she was 100% sure about it…Then he traveled to work in other country for 3 weeks. she changed his behavior completely. she disappeared every night, was saying she had to do some work and would talk to me later, but disappeared the rest of the day and night… no explanation, when I asked why she was disappearing every night, she stopped answering me. she’s ignoring me since last week, April 15. she ignored even my birthday, that was April 16. Not even a message. I wrote to her a few times trying to understand what happened, she read but just ignored me.I feel so bad cause I couldn’t stop contacting and trying to understand what happened.i loved her so much and wanted to get her back, then i was told to contact happylovespell2@gmail.com who can help out with a love spell to reunite your relationship back, so instantly do contact him and give him a try and trust me he did an urgent effective love spell for me and with in 48hours promise he made to me, my woman was back, today i testify to you all that you should seek and contact Dr happy for his spell result is genuine sure and guarantee unite and get your ex back save your marriage/relationship problem now, You can also know more about his spell Blogs site.http://happylovespel.blogspot.com.ng/ Email him now on.. happlovespell2@gmail.com If you want to talk for more info or consultation. Whatsapp/cal +2348133873774 Assurance and spell guarantee, visit his website...happylovespell2.webnode.com/
Guest
2018-07-10 15:30:06 +0200
I am very happy today with my family. My name is Shally Mills living in UK, My husband left me for a good 3 years now, and i love him so much, i have been looking for a way to get him back since then. i have tried many options but he did not come back, until i met a friend that darted me to Dr.Sam a spell cast, who helped me to bring back my husband after 24 HOURS. Me and my husband are living happily together today, That man is great, you can contact him via email Supremespellcast@gmail.com … Now i will advice any serious persons that found themselves in this kind of problem to contact him now a fast solution without steress.. He always hello, now i call him my father. contact him now he is always online email (Supremespellcast@gmail.com Or Supremespellcast@yahoo.com) or WhatsApp: +2347087462033 and also see more reviews about him on his website: http://supremespellcast.website2.me Or his blog> https://supremespellcast.blogspot.com
Guest
2018-07-07 16:22:23 +0200
I am very surprise for the miraculous experience and wonders of Dr gbojie that have been spreading on the Internet and worldwide, How he marvelously helped people all over the world to restored back their lost lovers I contacted him after going through so many testimonies from different people how he help to bring back ex lovers i was deeply in love with my boyfriend and he was with me but suddenly one day he broke up with me. I tried everything but nothing seemed to workout, I thought it was going to be over forever.I never believed in spells but I was so desperate I thought I got nothing else to loose. I started searching for different spell casters and I finally found ‘Great gbojie Temple’ who helped me through the process and I eventually got my boyfriend back and we are so happy together. I am so grateful to him. If you ever need a spell caster who can get you ex back then contact him on [gbojiespiritualtemple@gmail.com]and his telephone number is +2349066410185
Guest
2018-07-04 13:00:01 +0200
Powerful Effective Love Spell Get Your Ex Back About a month ago I got back to my ex(after 2 and half years separated).Everything was ok and she was the most adorable woman in the world. she spoke about wedding ceremony, how many kids we would have, said that our relationship was the most important thing in her life and she was 100% sure about it…Then he traveled to work in other country for 3 weeks. she changed his behavior completely. she disappeared every night, was saying she had to do some work and would talk to me later, but disappeared the rest of the day and night… no explanation, when I asked why she was disappearing every night, she stopped answering me. she’s ignoring me since last week, April 15. she ignored even my birthday, that was April 16. Not even a message. I wrote to her a few times trying to understand what happened, she read but just ignored me.I feel so bad cause I couldn’t stop contacting and trying to understand what happened.i loved her so much and wanted to get her back, then i was told to contact happylovespell2@gmail.com who can help out with a love spell to reunite your relationship back, so instantly do contact him and give him a try and trust me he did an urgent effective love spell for me and with in 48hours promise he made to me, my woman was back, today i testify to you all that you should seek and contact Dr happy for his spell result is genuine sure and guarantee unite and get your ex back save your marriage/relationship problem now, You can also know more about his spell Blogs site.http://happylovespel.blogspot.com.ng/ Email him now on.. happlovespell2@gmail.com If you want to talk for more info or consultation. Whatsapp/cal +2348133873774 Assurance and spell guarantee, visit his website...happylovespell2.webnode.com/
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