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A Phase 1/2 Study to Investigate the Safety, Biologic and Anti-tumor Activity of ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies

 


Purpose: This is a trial for patients with advanced peritoneal (the lining of the contents of the abdomen) cancer. Because uterine sarcoma can progress to peritoneal involvement, patients with advanced uterine sarcoma might qualify for this trial.
Authoritative site for this trial: At ClinicalTrials.gov
What is the treatment? It’s a treatment with two non-chemotherapy agents: ONCOS-102 (a virus targeting cancer cells) and Durvalumab (also called Imfinzi, it’s an antibody targeting a protein called PD-L1 that affects the immune system)
Is there a chance you'll get a placebo? No. This is not a randomized trial. But there are three arms( and in this study you will know which arm you are assigned to. The difference between the arms will be the dose of each of ONCOS-102 and Durbalumab and the timing of when these are given.
How old do you have to be? 18 years old or older
What phase study is this? Phase II
What includes you in trial?
  • Previously treated for advanced cancer with no additional therapy options available known to prolong survival.
  • You are is willing to undergo biopsies of the tumor (with a needle) during screening and during Cycle 2 of the study. Prior tumor samples will be asked of your pathologist, but are not required for eligibility.
  • You can get around on your own and take care of your daily life needs.
What excludes you from the trial?
  • Treatment with other anti-cancer or immune-stimulating antibodies
  • Brain involvement (e.g. metastases) of cancer
  • Other invasive cancers within the last 5 years.
  • Hepatitis viral infection or HIV infection
  • Bowel (aka GI tracts, “gut”), is perforated or leaking or showing signficant disease.
  • Serious Heart Disease
  • You have received an organ (including bone marrow) transplant
In USA? Yes
Sites where the trial is offered: Miami, Florida,
Buffalo, New York
Toledo, Ohio
Contact information: Lisa Shohara and Danielle McCabe
212-450-1515
clintrialinformation@licr.org