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XMT-1536 (upifitamab rilsodotin) for Ovarian Cancer (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months after the last dose for the last participant.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after the last dose for the last participant.
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 moreAwards & 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.
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Who is running the clinical trial?
GOG FoundationNETWORK
46 Previous Clinical Trials
17,710 Total Patients Enrolled
8 Trials studying Ovarian Cancer
2,905 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
38 Previous Clinical Trials
17,956 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has spread to your brain or spinal fluid and have not received treatment for it.You have received treatment with a specific type of medication called mirvetuximab soravtansine or other similar medications in the past.You have recently taken bevacizumab along with a platinum-based treatment, or you plan to continue taking medications outside of the study treatment.You have a history of liver problems like cirrhosis or fibrosis, or other serious liver diseases. Further testing may be done by the doctor to check for any other liver issues based on your medical history and risks.You have had or might have a lung condition called pneumonitis or interstitial lung disease in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: XMT-1536 (upifitamab rilsodotin)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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