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An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China

Study acronym: RAINFOL-02
StatusRecruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 20 words Secondary endpoints: details revised at 2 of 10 entries · Site details revised at 3 of 17 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site details revised at 3 of 17 sites
  2. Re-verified, no change to tracked fieldsv5
  3. Recruitment opened Trial sites reduced: 20 → 17 locations · Start date changed from estimate of Jun 2026 to Jun 26, 2026v4 Show 2 more changesShow less
    • Trial sites reduced: 20 → 17 locations
    • Start date changed from estimate of Jun 2026 to Jun 26, 2026
  4. Re-verified, no change to tracked fieldsv3
  5. Eligibility criteria expanded, about 9 wordsv2 See this version in full on ClinicalTrials.gov ↗
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Genmab
45 trials monitored
See 3 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo. This study is an extension study of the protocol GCT1184-02 (NCT06619236).
Trial Details
NCT Number NCT07604766
Lead Sponsor Genmab
Conditions Platinum-resistant Ovarian Cancer
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov