Study on Rucaparib and Nivolumab as Maintenance Treatment for Ovarian Cancer After Initial Chemotherapy
Sponsor: pharmaand GmbH
ClinicalTrials ID:NCT03522246
This clinical trial is testing whether the drugs Rucaparib and Nivolumab can help maintain the positive effects of initial chemotherapy in patients with newly diagnosed ovarian cancer. The study will look at how well these drugs work based on specific genetic features of the cancer.
Patient Parameters
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Program Overview
This Phase 3 study is being conducted in multiple countries to evaluate the effectiveness of Rucaparib and Nivolumab as maintenance treatments for patients with newly diagnosed ovarian cancer who have responded well to their first round of chemotherapy. The study will compare different treatment groups and analyze results based on the genetic characteristics of the cancer.
Eligibility Criteria
Inclusion Criteria
- Have been newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer (stage III-IV).
- Have completed surgery to remove as much of the cancer as possible, including removal of both ovaries and part of the omentum, either before or after starting chemotherapy.
- Have finished the first round of platinum-based chemotherapy and surgery with a positive response, as determined by the study doctor.
- Have enough tumor tissue available for planned genetic analysis.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Be at least 20 years old to participate in Japan, Taiwan, and South Korea, and at least 18 years old in other participating countries.
Exclusion Criteria
- Have certain types of tumors, such as pure sarcomas, borderline tumors, or mucinous tumors.
- Have another active cancer.
- Have known cancer spread to the brain.
- Have received any previous treatment for ovarian cancer other than the initial platinum-based chemotherapy.
- Have lung disease or active lung inflammation.
- Have an active or suspected autoimmune disease.
- Require ongoing treatment with high-dose steroids or other medications that suppress the immune system.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | 85016 | Phoenix | Arizona |
| Arizona Oncology Associates, PC - HOPE | 85711 | Tucson | Arizona |
| The University of Arizona Cancer Center | 85724 | Tucson | Arizona |
| John Muir Clinical Research Center | 94520 | Concord | California |
| UCLA Women's Health Clinical Research Unit | 90095 | Los Angeles | California |
| Kaiser Permanente Northern California | 94589 | San Francisco | California |
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| Rocky Mountain Cancer Centers | 80228 | Lakewood | Colorado |
| Yale University | 06520 | New Haven | Connecticut |
| Florida Gynecologic Oncology | 33905 | Fort Myers | Florida |
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