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

Active:	No
Cancer Type:	Ovarian Cancer	NCT ID:	NCT05329545
Trial Phases:	Phase III	Protocol IDs:	XMT-1536-3 (primary) NCI-2022-04396
Eligibility:	18 Years and older, Female	Study Type:	Treatment
Study Sponsor:	Mersana Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT05329545

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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