Tests Rina-S with standard treatment for recurrent ovarian cancer maintenance
Tests Rina-S with standard treatment in adults with returned ovarian cancer.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Aalborg, Copenhagen Oe, and Roskilde, DenmarkSee the 3 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: NCT07225270, who can take part
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkNot yet recruiting
- RigshospitaletCopenhagen Oe, DenmarkNot yet recruiting
- Region SjaellandRoskilde, DenmarkNot 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
- NCT07225270EU 2025-522167-15-00
- Record updated
- 6 October 2026
- Original description
This Phase 3 study will be conducted in different countries around the world with up to about 544 participants.Read full original descriptionShow less
A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)
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.
Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also 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 weeks). 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) for each participant will be different for every participant.
Inclusion: 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) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment; Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC; Must be randomized 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 platinum-based chemotherapy.
Exclusion: 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 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.