Spots Global Cancer Trial Database for Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas
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Trial Identification
Brief Title: Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas
Official Title: NiTraSarc Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas - The NiTraSarc Phase II Trial
Study ID: NCT03590210
Conditions
Study Description
Brief Summary: The "NiTraSarc" trial evaluates the efficacy and feasibility (as determined by the safety and tolerability) of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Helios Klinikum Bad Saarow, Klinik fßr Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum Berlin-Brandenburg, Bad Saarow, , Germany
Helios Klinikum Berlin Buch, Klinik fßr interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg, Berlin, , Germany
CharitÊ Universitätsmedizin Berlin, Campus Virchow Klinikum Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CC14), Berlin, , Germany
Medizinische Fakultät "Carl Gustav Carus" der TU Dresden, Medizinische Klinik I, Dresden, , Germany
Universitätsmedizin Greifswald, Klinik und Poliklinik fßr Innere Medizin C, Hämatologie und Onkologie, Greifswald, , Germany
Universitätsklinikum Medizinische Fakultät Mannheim der Universität Heidelberg, Interdisziplinäres Tumorzentrum Mannheim (ITM), Mannheim, , Germany
Universitätsklinikum Mßnster, Medizinische Klinik A Hämatologie / Onkologie / Pneumologie, Mßnster, , Germany
Universitätsklinikum Tßbingen, Innere Medizin II - Medizinische Onkologie und Pneumologie, Tßbingen, , Germany
Universitätsklinikum Wßrzburg, Medizinische Klinik und Poliklinik II Hämatologie / Onkologie, Wßrzburg, , Germany
Contact Details
Name: Daniel Pink, MD
Affiliation: Klinik und Poliklinik fßr Innere Medizin C, Hämatologie und Onkologie, Transplantationszentrum, Universitätsmedizin Greifswald
Role: PRINCIPAL_INVESTIGATOR
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