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Compares treatment options for Ovarian Cancer
Official title Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
ClinicalTrials.gov ID: NCT07225270
What this study is testing
What is Rina-S?
Rina-S is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Also referred to as Rinatabart sesutecan, GEN1184.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 3 study will be conducted in different countries around the world with up to about 544 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or...
- Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of primary (first-line [1L]) platinum therapy.
- Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who...
- Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
- Must be assigned by chance no later than 8 weeks from the last dose of the 2L platinum-based therapy.
You likely can't join if
- Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline...
- More than 2 prior lines of systemic therapy.
- Progression while on or following 2L platinum-based regimen prior to randomization.
- Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy...
See the full eligibility criteria
- Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
- Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of primary (first-line [1L]) platinum therapy.
- Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED)...
- Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
- Must be assigned by chance no later than 8 weeks from the last dose of the 2L platinum-based therapy.
- Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L...
- Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors
- More than 2 prior lines of systemic therapy.
- Progression while on or following 2L platinum-based regimen prior to randomization.
- Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization. Note: Other protocol-defined Inclusion and...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Sarasota, Florida, United States
- Centerville, Ohio, United States
- Columbus, Ohio, United States
- Sapporo, Hokkaido, Japan
- Akashi, Hyōgo, Japan
- Tsu, Mie-ken, Japan
- Takatsuki, Osaka, Japan
- Hidaka, Saitama, Japan
- Kashiwa, Japan
- Niigata, Japan
- Okayama, Japan
- Sagamihara, Japan
- Tokyo, Japan
- Yokohama, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Sarasota, Florida, United States; Centerville, Ohio, United States; Columbus, Ohio, United States; Sapporo, Hokkaido, Japan; Akashi, Hyōgo, Japan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.