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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05329545
Other study ID # XMT-1536-3
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 23, 2022
Est. completion date September 29, 2023

Study information

Verified date October 2023
Source Mersana Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date September 29, 2023
Est. primary completion date September 29, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 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: 1. Participant has received prior treatment with mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload. 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.

Study Design


Intervention

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:
Placebo
Placebo controlled arm.

Locations

Country Name City State
Australia Epworth Richmond Richmond Victoria
Canada Sherbrooke University Hospital Centre Quebec Sherbrooke
United States Southwest Women's Oncology Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Texas Oncology P.A. - Austin Austin Texas
United States Texas Oncology - DFWW Bedford Texas
United States Billings Clinic Billings Montana
United States University of Chicago Medical Center Chicago Illinois
United States University Hospitals Cleveland Medical Center, Seidman Cancer Center Cleveland Ohio
United States Karmanos Cancer Institute - Detroit Detroit Michigan
United States Willamette Valley Cancer Institute and Research Center Eugene Oregon
United States Kettering Health Cancer Center Kettering Ohio
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States University of California Los Angeles, Gynecologic Oncology Clinic Los Angeles California
United States University of Wisconsin Clinical Science Center Madison Wisconsin
United States Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Methodist Hospital Omaha Nebraska
United States University of California, Irvine Medical Center Orange California
United States HonorHealth Research Institute - HonorHealth VGPCC Biltmore Phoenix Arizona
United States Legacy Good Samaritan Medical Center - Legacy Medical Group - Gynecologic Oncology Portland Oregon
United States Center of Hope Reno Nevada
United States VCU Massey Cancer Center Richmond Virginia
United States Sarasota Memorial Hospital Sarasota Florida
United States WK Physicians Shreveport Louisiana
United States Avera McKennan d/b/a Avera Research Institute Sioux Falls South Dakota
United States Sanford Gynecologic Oncology Sioux Falls South Dakota
United States The University of Arizona Cancer Center Tucson Arizona
United States Texas Oncology - Tyler Tyler Texas
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Mersana Therapeutics European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 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. Up to 12 months after the last dose for the last participant.
Secondary Overall Survival (OS) OS is defined as the time from randomization to the date of death due to any cause. Up to an average of 4 years. Follow up assessments for survival data will continue every 90 days following completion of treatment.
Secondary Progression-free Survival (PFS) as assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 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. Up to 12 months after the last dose for the last participant.
Secondary Adverse events (AEs) based on NCI CTCAE Version 5.0 Incidence and toxicity grade of AEs. Up to 60 days past last dose
Secondary Changes in Eastern Cooperative Oncology Group (ECOG) performance status Assessment of ECOG performance status using ECOG performance scale. Up to 60 days past last dose.
Secondary Objective Response Rate (ORR) as assessed by Investigator using RECIST Version 1.1 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. Up to 12 months after the last dose for the last participant.
Secondary Number of participants using concomitant medications Assessment of concomitant medication usage. Up to 60 days past last dose.
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