Phase 2 Multicohort Study to Evaluate the Safety and Efficacy of Novel Treatment Combinations in Patients with Recurrent Ovarian Cancer
Why is the Opal study being done?
Treatment options for women who have recurrent platinum-resistant ovarian cancer are limited. Therefore, this clinical trial will study the effectiveness and safety of new treatment combinations, including niraparib (a PARP inhibitor), in women who have recurrent ovarian cancer. Each new treatment combination will be studied in a different group of women, and additional groups may be added in the future if a new promising treatment combination is identified. The first treatment combination that will be studied is niraparib given together with an immunotherapy drug (TSR-042) and bevacizumab (Avastin). There is scientific reason to believe that these drugs may work well together in women who have recurrent ovarian cancer.
NOTE: Enrollment goal has been reached.
This study is no longer enrolling new participants.
High-grade recurrent epithelial (i.e., serous, endometrioid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal cancer. Those who have high-grade mixed histology or carcinosarcoma are also eligible.
1-2 prior lines of chemotherapy and no prior treatment with a PARP inhibitor
- Known history of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
- Active autoimmune disease that has required treatment in the past 2 years
- Currently has a bowel obstruction or had one within the past 3 months or is otherwise felt by the Study Doctor to be at high risk for bowel obstruction related to the underlying disease.
HOW DO I KNOW IF THE OPAL TRIAL IS RIGHT FOR ME?
The best next step is to contact the research site that would be the most convenient for you in order to discuss your medical history and whether the OPAL clinical trial would be a good fit.
To find sites in your area, contact: email@example.com or use the form above.
To find additional information on OPAL see: clinicaltrials.gov