Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT) (UP-NEXT)
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|ClinicalTrials.gov Identifier: NCT05329545|
Recruitment Status : Terminated (Study Terminated by Sponsor)
First Posted : April 15, 2022
Last Update Posted : October 26, 2023
|Condition or disease||Intervention/treatment||Phase|
|High Grade Serous Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer||Drug: Upifitimab rilsodotin Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, randomized, placebo controlled (2:1 upifitamab rilsodotin: placebo). Parallel cohorts.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants With Recurrent, Platinum-Sensitive, Ovarian Cancer (UP-NEXT)|
|Actual Study Start Date :||June 23, 2022|
|Actual Primary Completion Date :||September 29, 2023|
|Actual Study Completion Date :||September 29, 2023|
Experimental: XMT-1536 (upifitamab rilsodotin)
XMT-1536 (upifitamab rilsodotin)
Drug: Upifitimab rilsodotin
Upifitimab rilsodotin will be administered once every four weeks until completion, disease progression, unacceptable toxicity, voluntary discontinuation, or death (approximately up to 18 months).
Other Name: XMT-1536 Antibody Drug Conjugate
Placebo Comparator: Placebo
Saline placebo will be administered with same schedule and stopping rules as for the assigned interventions in the Experimental Arm.
Placebo controlled arm.
- Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 12 months after the last dose for the last participant. ]PFS is defined as the time from randomization to the earliest date of progressive disease as assessed by BICR per RECIST Version 1.1 or death due to any cause.
- Overall Survival (OS) [ Time Frame: Up to an average of 4 years. Follow up assessments for survival data will continue every 90 days following completion of treatment. ]OS is defined as the time from randomization to the date of death due to any cause.
- Progression-free Survival (PFS) as assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 12 months after the last dose for the last participant. ]PFS is defined as the time from randomization to the earliest date of progressive disease as assessed by Investigator per RECIST Version 1.1 or death due to any cause.
- Adverse events (AEs) based on NCI CTCAE Version 5.0 [ Time Frame: Up to 60 days past last dose ]Incidence and toxicity grade of AEs.
- Changes in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to 60 days past last dose. ]Assessment of ECOG performance status using ECOG performance scale.
- Objective Response Rate (ORR) as assessed by Investigator using RECIST Version 1.1 [ Time Frame: Up to 12 months after the last dose for the last participant. ]ORR is the percentage of patients achieving a confirmed complete response (CR) or partial response (PR) as assessed by Investigator per RECIST Version 1.1.
- Number of participants using concomitant medications [ Time Frame: Up to 60 days past last dose. ]Assessment of concomitant medication usage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05329545
|Study Director:||Robert Burger, MD||Mersana Therapeutics|