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Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT) (UP-NEXT Trial)

Phase 3
Waitlist Available
Research Sponsored by Mersana Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after the last dose for the last participant.
Awards & highlights
Pivotal Trial

Summary

This trial tests XMT-1536, a medicine given regularly, in patients with certain types of ovarian cancer that have come back but still respond to specific treatments. The medicine targets and kills cancer cells with a specific protein.

Eligible Conditions
  • Ovarian Cancer
  • Peritoneal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after the last dose for the last participant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after the last dose for the last participant. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary study objectives
Adverse events (AEs) based on NCI CTCAE Version 5.0
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants using concomitant medications
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: XMT-1536 (upifitamab rilsodotin)Experimental Treatment1 Intervention
XMT-1536 (upifitamab rilsodotin)
Group II: PlaceboPlacebo Group1 Intervention
Saline placebo will be administered with same schedule and stopping rules as for the assigned interventions in the Experimental Arm.

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK
46 Previous Clinical Trials
17,630 Total Patients Enrolled
8 Trials studying Ovarian Cancer
2,905 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
18,186 Total Patients Enrolled
11 Trials studying Ovarian Cancer
5,017 Patients Enrolled for Ovarian Cancer
Mersana TherapeuticsLead Sponsor
10 Previous Clinical Trials
1,472 Total Patients Enrolled
2 Trials studying Ovarian Cancer
350 Patients Enrolled for Ovarian Cancer
Robert Burger, MDStudy DirectorMersana Therapeutics
6 Previous Clinical Trials
1,108 Total Patients Enrolled
2 Trials studying Ovarian Cancer
350 Patients Enrolled for Ovarian Cancer

Media Library

XMT-1536 (upifitamab rilsodotin) Clinical Trial Eligibility Overview. Trial Name: NCT05329545 — Phase 3
Ovarian Cancer Research Study Groups: Placebo, XMT-1536 (upifitamab rilsodotin)
Ovarian Cancer Clinical Trial 2023: XMT-1536 (upifitamab rilsodotin) Highlights & Side Effects. Trial Name: NCT05329545 — Phase 3
XMT-1536 (upifitamab rilsodotin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05329545 — Phase 3
~6 spots leftby Dec 2025
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