Ovarian Cancer Clinical Trial

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

Summary

UP-NEXT is a double-blind, randomized, placebo-controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks in patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC), including fallopian tube and primary peritoneal cancer, expressing high levels of NaPi2b.

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Full Description

This is a multi-center randomized study of XMT-1536 (upifitamab rilsodotin) in patients with tumors expressing high levels of NaPi2b, focusing on patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer. The randomized study design is a double-blind, placebo-controlled study, with a randomization ratio of 2:1. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Participants must have had 4 to 8 cycles of platinum-based chemotherapy in their most recent treatment regimen, including carboplatin or cisplatin ± paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine in the 2nd-4th line setting for the treatment of platinum-sensitive recurrent disease, with no evidence of disease (NED)/complete response (CR)/partial response (PR)/ or stable disease (SD) as best response.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant must have a histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube and primary peritoneal cancer, that is metastatic or recurrent.
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.

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:

Platinum-based chemotherapy regimens allowed immediately preceding enrollment to the study: carboplatin or cisplatin ±: paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine.
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.
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)
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.
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:

Participant has received prior treatment with mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload.
Participant has received bevacizumab in combination with last platinum-based regiment or plans to receive maintenance therapy outside the study intervention.
Participant has clinical signs or symptoms of gastrointestinal obstruction and/or requirement for parenteral hydration or nutrition.
Participant has ascites or pleural effusion managed with therapeutic paracentesis or thoracentesis within 28 days prior to signing the principal study consent form.
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.
Participant has history of or suspected pneumonitis or interstitial lung disease.
Participant has untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

350

Study ID:

NCT05329545

Recruitment Status:

Recruiting

Sponsor:

Mersana Therapeutics

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There are 24 Locations for this study

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Rocky Mountain Cancer Centers - Aurora
Aurora Colorado, 80012, United States More Info
Brandon Keith
Contact
Manojkumar Bupathi
Principal Investigator
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States More Info
Ana Lacombe
Contact
Brian Slomovitz
Principal Investigator
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States More Info
Angela Price
Contact
Beverly Long
Principal Investigator
Tampa General Hospital
Tampa Florida, 33606, United States More Info
Martin Marlene
Contact
Diana English
Principal Investigator
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States More Info
Melissa Shaw
Contact
Andrew Green
Principal Investigator
Maine Medical Partners, Division of Gynecologic Oncology
Scarborough Maine, 04074, United States More Info
Robin Donovan
Contact
Leslie Bradford
Principal Investigator
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City Missouri, 64132, United States More Info
Katie Burnside
Contact
Kristopher LyBarger
Principal Investigator
Billings Clinic
Billings Montana, 59101, United States More Info
Kim Bosket
Contact
Justin Bottsford-Miller
Principal Investigator
Women's Cancer Center of Nevada
Las Vegas Nevada, 89106, United States More Info
Jacky Amador
Contact
Nicola Spirtos
Principal Investigator
Center of Hope
Reno Nevada, 89433, United States More Info
Shannon Pierpoint
Contact
Peter Lim
Principal Investigator
University of New Mexico Cancer Center
Albuquerque New Mexico, 87106, United States More Info
Sheri Westgate
Contact
Emily Wu
Principal Investigator
Southwest Women's Oncology
Albuquerque New Mexico, 87109, United States More Info
Robert Kushner
Contact
Karen Finkelstein
Principal Investigator
Vidant Cancer Center - at Vidant Medical Center
Greenville North Carolina, 27834, United States More Info
Tamika Little
Contact
Grainger Lanneau
Principal Investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland Ohio, 44106, United States More Info
Nancy Fusco
Contact
Sarah Lynam
Principal Investigator
Kettering Health Cancer Center
Kettering Ohio, 45429, United States More Info
Molly Moore
Contact
Thomas Reid
Principal Investigator
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Erin Hemken
Contact
Debra Richardson
Principal Investigator
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States More Info
Jeanne Schaffer
Contact
Charles Anderson
Principal Investigator
Northwest Cancer Specialists PC
Portland Oregon, 97227, United States More Info
Susan Papenfuse
Contact
Erin Salinas
Principal Investigator
Women and Infants Hospital
Providence Rhode Island, 02905, United States More Info
Ann John
Contact
Elizabeth Lokic
Principal Investigator
Erlanger Womens Oncology
Chattanooga Tennessee, 37403, United States More Info
Kimberly Donelson
Contact
Stephen DePasquale
Principal Investigator
Texas Oncology P.A. - Austin
Austin Texas, 78745, United States More Info
Alfonzo Paredes
Contact
Lynne Knowles
Principal Investigator
Texas Oncology - Dallas Presbyterian Hospital
Dallas Texas, 75231, United States More Info
Libby Brandenburg
Contact
Kristi McIntyre
Principal Investigator
Texas Oncology - Fort Worth Cancer Center
Fort Worth Texas, 76006, United States More Info
Cynthia Schoenfeldt
Contact
Noelle Cloven
Principal Investigator
Texas Oncology - Tyler
Tyler Texas, 75702, United States More Info
K. Shelly Maxfield
Contact
Anna Priebe
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

350

Study ID:

NCT05329545

Recruitment Status:

Recruiting

Sponsor:


Mersana Therapeutics

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