Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- * Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC).
- * Has platinum-sensitive epithelial OC,
- * Has provided tissue of a tumor lesion that was not previously irradiated
- * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)
- * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- * Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
- * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma
- * Has platinum-resistant OC or platinum-refractory OC
- * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
- * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- * Has received more than 2 prior lines of systemic therapy for OC.
- * Has received prior systemic anticancer therapy
- * Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
- * Has an additional malignancy that is progressing or has required active treatment within the past 3 years
- * Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
- * Has an active infection requiring systemic therapy
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
FEMALE
Accepts Healthy Volunteers
No