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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

{ "Study of Rina-S for Recurrent Platinum-Sensitive Ovarian Cancer", "This study is looking at Rina-S, with or without bevacizumab, as a treatment for recurrent platinum-sensitive ovarian cancer. This is for women whose cancer has returned after initial platinum-based chemotherapy. Researchers want to see how well Rina-S works compared to standard chemotherapy options (investigator's choice of carboplatin, gemcitabine, or paclitaxel), also with or without bevacizumab. You would be randomly assigned to one of these treatment groups. The study aims to measure how long people live without their cancer growing (progression-free survival). This global study plans to enroll up to 688 participants, but its current recruitment status is unclear.", "design": "This is a global, open-label, randomized Phase 3 study involving up to 688 participants. You would be randomly assigned to one of two treatment arms.", "commitments": "Participants will receive Rina-S, Rina-S plus bevacizumab, standard chemotherapy, or standard chemotherapy plus bevacizumab. The duration of treatment will vary for each participant.", "compensation": "Not stated in the trial record.", "follow_up": "Your progression-free survival will be measured for up to approximately 3 years.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07564141

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Genmab
~688 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Rina-SBevacizumabCarboplatinGemcitabinePaclitaxelPLD

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Measured over Up to approximately 3 years

Conditions

Platinum-Sensitive Ovarian Cancer
Ovarian Cancer

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NCT07564141

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Danbury Hospital

    Danbury, Connecticutno site contact published

    Recruiting

  • ProHealth Care Inc

    Waukesha, Wisconsinno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Official · STUDY_DIRECTOR · Genmab

Who to contact

Genmab Trial Information
[email protected]
+4570202728
Email the study team

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Eligibility criteria

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

Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
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).

What this trial measures

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)Up to approximately 3 years