Rina-S compared with standard chemotherapy for ovarian cancer that returned after platinum treatment
Compares Rina-S, with or without bevacizumab, to chemotherapy in recurrent platinum-sensitive ovarian cancer.
Plain-language title generated from the registry record
Registry title: Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer
Key facts
- Where
- Berlin, Bonn, Dresden, Duesseldorf, Erlangen, Essen, Frankfurt Am Main, Freiburg im Breisgau, Homburg, and Magdeburg, GermanySee the 10 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you ever been told you have ovarian, fallopian tube or peritoneal cancer?
- Which best describes your most recent course of platinum chemotherapy (such as carboplatin or cisplatin)?
- What type of ovarian cancer do you have?
Source: NCT07564141, who can take part
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- Universitaetsklinikum Bonn AöRBonn, GermanyNot yet recruiting
- Technische Universitaet DresdenDresden, GermanyNot yet recruiting
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyNot yet recruiting
- Universitaetsklinikum Erlangen AöRErlangen, GermanyNot yet recruiting
- Universitaetsklinikum Essen (AoR)Essen, GermanyNot yet recruiting
- Goethe University FrankfurtFrankfurt Am Main, GermanyNot yet recruiting
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyNot yet recruiting
- Universitaet Des SaarlandesHomburg, GermanyNot yet recruiting
- Otto Von Guericke Universitaet MagdeburgMagdeburg, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genmab
- Trial code
- NCT07564141EU 2025-524202-15-00
- Record updated
- 4 November 2026
- Original description
This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.Read full original descriptionShow less
A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer
This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.
Participants will receive either:
* Rina-S monotherapy (by itself), * Rina-S plus bevacizumab, * investigator's choice chemotherapy (by itself) (standard of care), or * investigator's choice chemotherapy plus bevacizumab (standard of care).
No participants will be given placebo. Participants will participate in 1 of 2 arms.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.
The overall study duration (including screening, treatment, and follow-up) will be different for every participant.
Inclusion: Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer; Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, >183 days) after their last dose administration of platinum-based therapy; Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease; Participants must have measurable disease per RECIST v1.1 by investigator at baseline; All participants must provide a tumor specimen; Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.
Exclusion: Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar; Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor; Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα); Note: Other protocol-defined Inclusion and Exclusion criteria may apply; Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.