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Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

Study acronym: RAINFOL-03
StatusRecruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 171 → 177 locations Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 2 of 8 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 8 entries
  2. Trial sites expanded: 160 → 171 locationsv17
  3. Trial sites expanded: 147 → 160 locationsv16
  4. Trial sites expanded: 120 → 147 locationsv15
  5. Trial sites expanded: 81 → 120 locationsv14
  6. Trial sites expanded: 74 → 81 locationsv13
  7. Primary completion pushed from Nov 2028 to Aug 2029 Primary endpoint(s) modified · Enrollment increased: 544 → 660 participants · Trial sites expanded: 51 → 74 locations · 4 morev12 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 544 → 660 participants
    • Trial sites expanded: 51 → 74 locations
    • Completion pushed from Feb 2029 to Nov 2029
    • Secondary endpoints revised (8)
    • Study description revised
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 15 to 51v11
  9. Re-verified, no change to tracked fieldsv10
  10. Study sites: 9 to 15v9
  11. Study sites: 3 to 9v8
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Nov 21, 2025 to Nov 28, 2025v7 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Nov 21, 2025 to Nov 28, 2025
  13. Re-verified, no change to tracked fieldsv6
  14. Study Status, Eligibilityv5
  15. Start date: Oct 15, 2025 to Nov 21, 2025v4
  16. 2 versions Re-verified since Sep 12, 2025, no change to tracked fieldsv2-v3
  17. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Endometrial Cancer
633 trials monitored
See 40 trials at risk
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
Trial Details
NCT Number NCT07166094
Lead Sponsor Genmab
Conditions Endometrial Cancer, Recurrent or Progressive Endometrial Cancer
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov