Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT03824704
Eligibility Criteria:
General Inclusion Criteria:
* ≥ 18 years of age
* Adequate organ function
* Life expectancy ≥ 16 weeks
* Women of childbearing potential must have a negative serum pregnancy test
* High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease
* Relapsed/progressive disease (confirmed by radiologic assessment)
* Willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment.
* Measurable disease (RECIST v1.1)- Cohort A1 only
* ECOG performance status of 0 to 1
General Exclusion Criteria
* Active second malignancy
* Central nervous system brain metastases
* Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis.
* Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).
* Condition requiring systemic treatment with either corticosteroids
* Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.
* Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are allowed.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03824704
Study Brief:
Protocol Section:
NCT03824704