Study on Rina-S Plus Standard Treatment vs. Standard Treatment for Maintenance in Recurrent Platinum-sensitive Ovarian Cancer
Sponsor: Genmab
ClinicalTrials ID:NCT07225270
This Phase 3 clinical trial is testing how well the drug Rina-S works when combined with standard treatments for ovarian cancer that has returned and is sensitive to platinum-based chemotherapy. The study involves up to 528 participants worldwide.
Patient Parameters
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Program Overview
The study aims to see if Rina-S, either alone or with the drug bevacizumab, is effective in treating ovarian cancer that has come back after initial treatment. Participants will be divided into groups to receive either Rina-S alone, Rina-S with bevacizumab, bevacizumab alone, or just monitoring. The treatment will continue as long as the cancer does not worsen and there are no serious side effects. Participants will visit the clinic 1 to 3 times every 3 weeks for tests and monitoring. The total time in the study will vary for each person.
Description
This is a Phase 3 study comparing Rina-S plus standard treatment to standard treatment alone for maintaining health in patients with recurrent platinum-sensitive ovarian cancer. Participants will have either high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The study will assess how well Rina-S works in combination with standard care after patients have received a second round of platinum-based chemotherapy. Participants will be randomly assigned to different treatment groups and will continue treatment as long as it is effective and safe. Regular clinic visits will include tests and procedures to monitor health and treatment effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Cancer must have returned more than 6 months after the first round of platinum-based chemotherapy.
- If the cancer has certain genetic mutations and responded well to initial treatment, participants must have had previous maintenance therapy.
- Completed a second round of platinum-based chemotherapy for recurrent cancer.
- Must join the study within 8 weeks of finishing the second round of chemotherapy.
- Cancer must have shown a complete or partial response, or stable disease if bevacizumab was used in the second round of treatment.
Exclusion Criteria
- Have clear cell, mucinous, or sarcomatous ovarian cancer, or mixed tumors with these types.
- Have had more than two previous lines of treatment.
- Cancer progressed during or after the second round of platinum-based chemotherapy before joining the study.
- Received other cancer treatments (except bevacizumab) after the second round of chemotherapy and before joining the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mt. Sinai Comprehensive Cancer Center | 33140 | Miami | Florida |
| Miami Valley Hospital South | 45459 | Centerville | Ohio |
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