P.J. : Que grande que Yondelis vaya en I+D combinado con Opdivo de Bristol-Myers . Un Fármaco que genera más de 4000 Millones al año y líder en Tratamientos con Inmunoterapia . Y es que Yondelis podría ayudar a Opdivo a conseguir aún mayores cotas de éxito
Aparte de este ensayo de Yondelis con Nivolumab ( Opdivo ) ... En breve vamos a tener noticias de otra Combinación de Yondelis con xxxx ( este nuevo ensayo aún por comunicar sería mi sueño hecho realidad por fin ... ) .
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Tratamiento Combinado con Nivolumab ( Opdivo de Bristol Myers ) y Trabectedin ( Yondelis de PharmaMar ) en Pacientes con Sarcomas de Tejido Blando Metastásicos o Inoperables . (NiTraSarc) .
Undoubtedly, there is a strong medical need for new efficacious therapies for patients with advanced soft tissue sarcomas. While immune oncology treatment approaches like inhibition of immune checkpoints by administration of anti PD-1 / PD-L1 antibodies displayed very promising clinical activity in several types of tumors, current data points out to only limited activity of mono-agent immunotherapy in soft tissue sarcomas (especially in leiomyosarcomas) - although this type of tumor demonstrably displays a certain grade of immunogenicity. That means, STS patients are currently not able to benefit from the advancements in cancer immunotherapy which led to remarkable improvements in outcome in some other tumor entities in the last few years.
Interestingly, most recent data indicates that trabectedin could enhance the activity of immune-modulating agents via its influence on the tumor micro-environment and the reduction of tumor associated macrophages. Furthermore, first clinical data obtained from a feasibility study on combined nivolumab/trabectedin therapy in STS patients did not report on significant toxicities when combining the two agents, thereby justifying combination of nivolumab and trabectedin utilizing standard dosages.
Therefore, this phase II study will examine if combination of nivolumab with trabectedin is feasible (safe and well tolerated) and efficacious by utilizing potential synergistic effects of both agents. In the long run, the results of this phase II trial could build the basis for further evaluation of the efficacy of the trabectedin / nivolumab combination in a randomized clinical trial involving larger patient numbers. Finally, this could render patients with STS accessible to immunotherapeutics - a promising new class of drugs for anti-cancer treatment.
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Sponsors and Collaborators:
* University Medicine Greifswald
* IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
* PharmaMar
* Bristol-Myers Squibb .
Investigators :
Principal Investigator: Daniel Pink, MD Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie, Transplantationszentrum, Universitätsmedizin Greifswald .
Responsible Party :
University Medicine Greifswald
