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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 acronym: RAINFOL™-07
StatusRecruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 2 → 9 locations Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 2 of 10 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Minor Start date changed from estimate of Aug 2026 to Aug 28, 2026v6
  3. Minor Start date: Jul 2026 to Aug 2026v5
  4. Notable Recruitment opened Site details revised at 2 of 2 sitesv4 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  5. Minor Study sites: 0 to 2v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
45 trials monitored
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1,245 trials monitored
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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.
Trial Details
NCT Number NCT07564141
Lead Sponsor Genmab
Conditions Platinum-Sensitive Ovarian Cancer, Ovarian Cancer
Enrollment 688 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov