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A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas

 


Purpose: For sarcoma patients (not just uterine sarcoma) who have not responded to conventional therapy, will a combination of chemotherapy and immune therapy (boosting immune action against the cancer) work?
Authoritative site for this trial:  At ClinicalTrials.gov
What is the treatment? Eribulin (the chemotherapy) and Pembrolizumab (the immunotherapy). Both are intravenous treatments.
Is there a chance you'll get a placebo? No (and this is NOT a randomized trial where you get assigned to treatments by random selection.)
How old do you have to be? At least 18
What phase study is this? Phase II (see glossary)
What includes you in trial?
  • Prior treatment with chemotherapy.
  • Disease (tumor) measurable on CT scan or other imaging technique.
  • A pathologist from MGH or DFCI confirms your diagnosis. This means either access to tumor previously removed surgically (check with your surgeon, they will know how to retrieve from the pathology archives the tissue previously removed) or getting a biopsy now.
  • You are able to move around and do basic self-care.
  • Liver, kidneys and blood tests close to normal.
  • Not pregnant
  • What excludes you from the trial?
  • Previous treatment with Erlubin or Pembrolizumab.
  • Chemotherapy or radiation therapy within the last 3 weeks
  • Brain metastases untreated or affecting your function.
  • Experimental treatment within the last three weeks.
  • Autoimmune disease (eg. rheumatoid arthritis, Lupus)
  • Recent live vaccine
  • In USA? Yes
    Sites where the trial is offered:  Boston, MA: MGH or DFCI
    Contact information: Edwin Choy, MD echoy@partners.org or
    Michael Nathenson, MD 617-632-5204 Michaelj_nathenson@dfci.harvard.edu