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
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.