Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
18 Years and older, Female
XMT-1536-3 (primary)
NCI-2022-04396
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.
Objectives
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.
Eligibility
- 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.
Treatment Sites in Georgia
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