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Pivotal announces participation in two clinical trials with a novel investigational immunot

Pivotal announces participation in two clinical trials with a novel investigational immunotherapy drug to treat melanoma and lung cancer

Publish date: 2019-07-11

Pivotal, a specialist CRO, has been awarded two clinical trials for a novel investigational immunotherapy drug and patients' enrolment has now started. Pivotal will use its deep knowledge of oncology drug development to address a critical need for the expansion of immunotherapy programmes for Metastatic Melanoma (MM) and Non-Small Cell Lung Cancer (NSCLC) patients.

Tags: clinical trials , pivotal , immunotherapy , Metastatic Melanoma , Non-Small Cell Lung Cancer

Immunotherapy has shown very promising results in the treatment of some solid tumours. This therapeutic approach has become available for more cancer patients but, despite these advances, there are still many of these patients with unmet medical needs. The current programme for these trials will be supported by Pivotal as CRO and is focused on the clinical development of an investigational immunotherapy drug which mobilises the patient's innate and adaptive immune systems to try to defeat cancer. 

The incidence of malignant MM is estimated to impact 3-5/100,000 individuals in European countries and 5/100,000 in the US, and NSCLC is the most frequent tumour in both sexes, with 80-100/100,000 individuals in both USA and Europe. 

Activating therapeutic anti-tumour immunity by the modulation of the host immune system has become a key approach for treating several solid tumours. Antagonistic monoclonal antibodies (mAb) against immune inhibitory molecules such as cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and programmed death receptor-1 (PD-1) have improved survival of patients with MM and are already a standard of care. NSCLC immunotherapy has also been incorporated into the standard approaches in several settings, used either as monotherapy or combined with chemotherapy, depending on PD-L1 status, in the first line setting or, as monotherapy, in already pretreated patients.

This investigational immunotherapy drug will be tested under two different approaches (as monotherapy and as a combined treatment with an anti-PD1) in two different phase II clinical trials, the first one in MM patients and the second one in combination with an anti-PD1 in second line MM and NSCLC patients. Both trials will include up to 200 patients from 25 sites across the EU and US and will assess clinical benefit in terms of overall response rate and survival benefit as a primary objective. 

"The power of partnerships, such as the one we are embarking on here brings together the best minds and capabilities to accelerate this dynamic area of research and bring therapies to patients with high unmet needs," said Dr Lourdes Huarte, VP Regulatory and Clinical Operations at Pivotal. "We are delighted to have started enrolment of patients in these two crucial trials and to have been able to deploy our capabilities to accelerate the development of medicines in such a difficult-to-treat area."

Pivotal is working in close partnership with a sponsor in the execution of this development programme across the US and EU, providing its resources to increase and streamline operational efficiency, including Start-up, Regulatory, Clinical Operations, Medical Monitoring, Data Management and Biostatistics among other operational services. 

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2019-09-05 22:46:35 +0200
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2019-09-05 22:46:08 +0200
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2019-09-04 03:05:27 +0200
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2019-08-22 00:09:18 +0200
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2019-08-20 11:27:24 +0200
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2019-08-17 20:49:58 +0200
Get Your Wife Back, Perfect Urgent Love Spell. Am Alexis scorpio from FL Usa All Thanks To Dr happy Who Brought Back The Love Of My Life. my girlfriend cheated on me and asked for a breakup. I don't believe at first i try to get back with her but all she told me was she’s with someone else. that she is no longer interested in marrying me at that point i was heart broken coz i love my girlfriend so much that i could not let go off her all of a sudden she left me, i really love her and never can imagine my life without her. not until i came across a powerful real spell caster Dr happy who promise me 24hours urgent love spell to get back with my girlfriend, good twenty-four {24} hours. hmm-mm, it was a good night time at 11:pm within the days that Dr happy told me that my girlfriend will be back, at first i heard the bell rings getting close to my door i heard someone saying honey!!!, it sound familiar i opened the door and i saw my girlfriend standing and weeping in front of me. i was not surprised because its all i have been praying for her to come back home. Guess what 2 weeks after she noticed her system and her body temperature was changed and i took her to clinic for check up and the doctor told me that there is life in her which means she was pregnant i really wants to use this opportunity to thanks Dr happy so much and the love page that directed me to Dr happy if you have any problem getting your ex back, or predicament that is worse or exactly like this you have been into, contact Dr happy on happylovespell2@gmail.com Whatsapp/cal +2348133873774 visit his website...happylovespell2.webnode.com/ about his love spell Blogs site.http://happylovespel.blogspot.com.ng/
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2019-08-12 11:43:13 +0200
Get Your Wife Back, Perfect Urgent Love Spell. Am Alexis scorpio from FL Usa All Thanks To Dr happy Who Brought Back The Love Of My Life. my girlfriend cheated on me and asked for a breakup. I don't believe at first i try to get back with her but all she told me was she’s with someone else. that she is no longer interested in marrying me at that point i was heart broken coz i love my girlfriend so much that i could not let go off her all of a sudden she left me, i really love her and never can imagine my life without her. not until i came across a powerful real spell caster Dr happy who promise me 24hours urgent love spell to get back with my girlfriend, good twenty-four {24} hours. hmm-mm, it was a good night time at 11:pm within the days that Dr happy told me that my girlfriend will be back, at first i heard the bell rings getting close to my door i heard someone saying honey!!!, it sound familiar i opened the door and i saw my girlfriend standing and weeping in front of me. i was not surprised because its all i have been praying for her to come back home. Guess what 2 weeks after she noticed her system and her body temperature was changed and i took her to clinic for check up and the doctor told me that there is life in her which means she was pregnant i really wants to use this opportunity to thanks Dr happy so much and the love page that directed me to Dr happy if you have any problem getting your ex back, or predicament that is worse or exactly like this you have been into, contact Dr happy on happylovespell2@gmail.com Whatsapp/cal +2348133873774 visit his website...happylovespell2.webnode.com/ about his love spell Blogs site.http://happylovespel.blogspot.com.ng/
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2019-08-07 17:42:44 +0200
Get Your Wife Back, Perfect Urgent Love Spell. Am Alexis scorpio from FL Usa All Thanks To Dr happy Who Brought Back The Love Of My Life. my girlfriend cheated on me and asked for a breakup. I don't believe at first i try to get back with her but all she told me was she’s with someone else. that she is no longer interested in marrying me at that point i was heart broken coz i love my girlfriend so much that i could not let go off her all of a sudden she left me, i really love her and never can imagine my life without her. not until i came across a powerful real spell caster Dr happy who promise me 24hours urgent love spell to get back with my girlfriend, good twenty-four {24} hours. hmm-mm, it was a good night time at 11:pm within the days that Dr happy told me that my girlfriend will be back, at first i heard the bell rings getting close to my door i heard someone saying honey!!!, it sound familiar i opened the door and i saw my girlfriend standing and weeping in front of me. i was not surprised because its all i have been praying for her to come back home. Guess what 2 weeks after she noticed her system and her body temperature was changed and i took her to clinic for check up and the doctor told me that there is life in her which means she was pregnant i really wants to use this opportunity to thanks Dr happy so much and the love page that directed me to Dr happy if you have any problem getting your ex back, or predicament that is worse or exactly like this you have been into, contact Dr happy on happylovespell2@gmail.com Whatsapp/cal +2348133873774 visit his website...happylovespell2.webnode.com/ about his love spell Blogs site.http://happylovespel.blogspot.com.ng/
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2019-08-05 11:59:29 +0200
How I Got My Ex Husband Back........... I am Shannon by name. Greetings to every one that is reading this testimony. I have been rejected by my husband after three(3) years of marriage just because another woman had a spell on him and he left me and the kid to suffer. one day when i was reading through the web, i saw a post on how this spell caster on this address Makospelltemple@yahoo.com , have help a woman to get back her husband and i gave him a reply to his address and he told me that a woman had a spell on my husband and he told me that he will help me and after 2 days that i will have my husband back. i believed him and today i am glad to let you all know that this spell caster have the power to bring lovers back. because i am now happy with my husband. Thanks for Dr.Mako. His email: Makospelltemple@yahoo.com OR.His WhatsApp Number:+2347054263874.
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2019-08-02 09:54:58 +0200
Get Your Wife Back, Perfect Urgent Love Spell. Am Alexis scorpio from FL Usa All Thanks To Dr happy Who Brought Back The Love Of My Life. my girlfriend cheated on me and asked for a breakup. I don't believe at first i try to get back with her but all she told me was she’s with someone else. that she is no longer interested in marrying me at that point i was heart broken coz i love my girlfriend so much that i could not let go off her all of a sudden she left me, i really love her and never can imagine my life without her. not until i came across a powerful real spell caster Dr happy who promise me 24hours urgent love spell to get back with my girlfriend, good twenty-four {24} hours. hmm-mm, it was a good night time at 11:pm within the days that Dr happy told me that my girlfriend will be back, at first i heard the bell rings getting close to my door i heard someone saying honey!!!, it sound familiar i opened the door and i saw my girlfriend standing and weeping in front of me. i was not surprised because its all i have been praying for her to come back home. Guess what 2 weeks after she noticed her system and her body temperature was changed and i took her to clinic for check up and the doctor told me that there is life in her which means she was pregnant i really wants to use this opportunity to thanks Dr happy so much and the love page that directed me to Dr happy if you have any problem getting your ex back, or predicament that is worse or exactly like this you have been into, contact Dr happy on happylovespell2@gmail.com Whatsapp/cal +2348133873774 visit his website...happylovespell2.webnode.com/ about his love spell Blogs site.http://happylovespel.blogspot.com.ng/
Guest
2019-07-29 02:43:58 +0200
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Guest
2019-07-27 17:59:08 +0200
Get Your Wife Back, Perfect Urgent Love Spell. Am Alexis scorpio from FL Usa All Thanks To Dr happy Who Brought Back The Love Of My Life. my girlfriend cheated on me and asked for a breakup. I don't believe at first i try to get back with her but all she told me was she’s with someone else. that she is no longer interested in marrying me at that point i was heart broken coz i love my girlfriend so much that i could not let go off her all of a sudden she left me, i really love her and never can imagine my life without her. not until i came across a powerful real spell caster Dr happy who promise me 24hours urgent love spell to get back with my girlfriend, good twenty-four {24} hours. hmm-mm, it was a good night time at 11:pm within the days that Dr happy told me that my girlfriend will be back, at first i heard the bell rings getting close to my door i heard someone saying honey!!!, it sound familiar i opened the door and i saw my girlfriend standing and weeping in front of me. i was not surprised because its all i have been praying for her to come back home. Guess what 2 weeks after she noticed her system and her body temperature was changed and i took her to clinic for check up and the doctor told me that there is life in her which means she was pregnant i really wants to use this opportunity to thanks Dr happy so much and the love page that directed me to Dr happy if you have any problem getting your ex back, or predicament that is worse or exactly like this you have been into, contact Dr happy on happylovespell2@gmail.com Whatsapp/cal +2348133873774 visit his website...happylovespell2.webnode.com/ about his love spell Blogs site.http://happylovespel.blogspot.com.ng/
Guest
2019-07-23 16:41:37 +0200
Get Your Wife Back, Perfect Urgent Love Spell. Am Alexis scorpio from FL Usa All Thanks To Dr happy Who Brought Back The Love Of My Life. my girlfriend cheated on me and asked for a breakup. I don't believe at first i try to get back with her but all she told me was she’s with someone else. that she is no longer interested in marrying me at that point i was heart broken coz i love my girlfriend so much that i could not let go off her all of a sudden she left me, i really love her and never can imagine my life without her. not until i came across a powerful real spell caster Dr happy who promise me 24hours urgent love spell to get back with my girlfriend, good twenty-four {24} hours. hmm-mm, it was a good night time at 11:pm within the days that Dr happy told me that my girlfriend will be back, at first i heard the bell rings getting close to my door i heard someone saying honey!!!, it sound familiar i opened the door and i saw my girlfriend standing and weeping in front of me. i was not surprised because its all i have been praying for her to come back home. Guess what 2 weeks after she noticed her system and her body temperature was changed and i took her to clinic for check up and the doctor told me that there is life in her which means she was pregnant i really wants to use this opportunity to thanks Dr happy so much and the love page that directed me to Dr happy if you have any problem getting your ex back, or predicament that is worse or exactly like this you have been into, contact Dr happy on happylovespell2@gmail.com Whatsapp/cal +2348133873774 visit his website...happylovespell2.webnode.com/ about his love spell Blogs site.http://happylovespel.blogspot.com.ng/
Guest
2019-07-23 16:20:53 +0200
How I Got My Ex Husband Back........... I am Shannon by name. Greetings to every one that is reading this testimony. I have been rejected by my husband after three(3) years of marriage just because another woman had a spell on him and he left me and the kid to suffer. one day when i was reading through the web, i saw a post on how this spell caster on this address Makospelltemple@yahoo.com , have help a woman to get back her husband and i gave him a reply to his address and he told me that a woman had a spell on my husband and he told me that he will help me and after 2 days that i will have my husband back. i believed him and today i am glad to let you all know that this spell caster have the power to bring lovers back. because i am now happy with my husband. Thanks for Dr.Mako. His email: Makospelltemple@yahoo.com OR.His WhatsApp Number:+2347054263874.
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