Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
NCT ID: NCT05329545
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
20 participants
INTERVENTIONAL
2022-06-23
2023-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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XMT-1536 (upifitamab rilsodotin)
XMT-1536 (upifitamab rilsodotin)
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).
Placebo
Saline placebo will be administered with same schedule and stopping rules as for the assigned interventions in the Experimental Arm.
Placebo
Placebo controlled arm.
Interventions
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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).
Placebo
Placebo controlled arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant must have platinum-sensitive recurrent disease, defined as having achieved either a partial or complete response to 4 or more cycles in their penultimate platinum- containing regimen and their disease progressing more than 6 months after completion of the last dose of platinum containing therapy in the penultimate regimen.
3. Participant must have had 4 to 8 cycles of platinum-based chemotherapy in 2nd to 4th line setting in their most recent treatment regimen as defined below:
1. Platinum-based chemotherapy regimens allowed immediately preceding enrollment to the study: carboplatin or cisplatin ±: paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine.
2. Participant must receive first study treatment infusion between 4 and 12 weeks after completing final dose of platinum in the most recent platinum-based regimen.
4. Participant must have had as their best response to last line of treatment one of the following: No Evidence of Disease (NED); Complete Response (CR); Partial Response (PR); OR Stable Disease (SD)
5. Participants with NED, CR, or PR as their best response to most recent line of treatment and who have not received treatment with a prior PARP inhibitor must have definitive BRCA1 and BRCA2 testing results that demonstrate no evidence of a deleterious BRCA1 or BRCA2 mutation. Somatic BRCA mutation testing is required for participants who are classified as not having a deleterious mutation by germline testing alone.
6. Participant must provide either a tumor tissue block or fresh cut slides for measurement of NaPi2b expression by a central laboratory. If sufficient archival tumor tissue is not available, then a tumor tissue block or slides must be obtained from a fresh biopsy and provided to the central laboratory. Confirmation of a NaPi2b-H/positive tumor by the central laboratory is required prior to randomization.
Exclusion Criteria
2. Participant has received bevacizumab in combination with last platinum-based regiment or plans to receive maintenance therapy outside the study intervention.
3. Participant has clinical signs or symptoms of gastrointestinal obstruction and/or requirement for parenteral hydration or nutrition.
4. Participant has ascites or pleural effusion managed with therapeutic paracentesis or thoracentesis within 28 days prior to signing the principal study consent form.
5. Participant has history of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease. Testing beyond laboratory studies otherwise defined in the eligibility criteria, to diagnose potentially clinically significant liver disease based on risk factors such as hepatic steatosis or history of excessive alcohol intake, will be based on clinical judgement of the investigator.
6. Participant has history of or suspected pneumonitis or interstitial lung disease.
7. Participant has untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Mersana Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Burger, MD
Role: STUDY_DIRECTOR
Mersana Therapeutics
Locations
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HonorHealth Research Institute - HonorHealth VGPCC Biltmore
Phoenix, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
University of California Los Angeles, Gynecologic Oncology Clinic
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
WK Physicians
Shreveport, Louisiana, United States
Karmanos Cancer Institute - Detroit
Detroit, Michigan, United States
Billings Clinic
Billings, Montana, United States
Methodist Hospital
Omaha, Nebraska, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Center of Hope
Reno, Nevada, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Southwest Women's Oncology
Albuquerque, New Mexico, United States
University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio, United States
Kettering Health Cancer Center
Kettering, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Legacy Good Samaritan Medical Center - Legacy Medical Group - Gynecologic Oncology
Portland, Oregon, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Sanford Gynecologic Oncology
Sioux Falls, South Dakota, United States
Avera McKennan d/b/a Avera Research Institute
Sioux Falls, South Dakota, United States
Texas Oncology P.A. - Austin
Austin, Texas, United States
Texas Oncology - DFWW
Bedford, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Epworth Richmond
Richmond, Victoria, Australia
Sherbrooke University Hospital Centre
Québec, Sherbrooke, Canada
Countries
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Other Identifiers
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XMT-1536-3
Identifier Type: -
Identifier Source: org_study_id
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