Clinical Trial Title A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Upifitamab Rilsodotin as Post-Platinum Maintenance Therapy for Participants with Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Trial Status Open to Enrollment
Start Date 11/10/2022
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description 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.
Eligibility Criteria

Inclusion Criteria

  • Participants must be at least 18 years of age, and female.
  • Participant must have an ECOG performance status 0 or 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.
  • 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.

Exclusion Criteria

Participant will not be eligible for study entry if any of the following criteria are met:

  • Participant has received bevacizumab in combination with last platinum-based regimen or plans to receive maintenance therapy outside the study intervention.
  • Participant has had major surgery or systemic anti-cancer therapy within 28 days of starting study treatment.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT) - Full Text View - ClinicalTrials.gov
Principal Investigator Gina Westhoff, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org