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

(UP-NEXT Trial)

Recruiting at73 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Mersana Therapeutics

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests XMT-1536, a medicine given regularly, in patients with certain types of ovarian cancer that have come back but still respond to specific treatments. The medicine targets and kills cancer cells with a specific protein.

Research Team

Robert Burger, MD

Principal Investigator

Mersana Therapeutics

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Participant has clinical signs or symptoms of gastrointestinal obstruction and/or requirement for parenteral hydration or nutrition.

Participant has ascites or pleural effusion managed with therapeutic paracentesis or thoracentesis within 28 days prior to signing the principal study consent form.

You have cancer that has spread to your brain or spinal fluid and have not received treatment for it.

Treatment Details

Interventions

• Upifitamab Rilsodotin (Antibody-Drug Conjugate)

Participant Groups

Group I: XMT-1536 (upifitamab rilsodotin) Experimental Treatment 1 Intervention

XMT-1536 (upifitamab rilsodotin)

Group II: Placebo Placebo Group 1 Intervention

Saline placebo will be administered with same schedule and stopping rules as for the assigned interventions in the Experimental Arm.

Who Is Running the Clinical Trial?

Mersana Therapeutics

Lead Sponsor

Trials

11

Recruited

1,500+

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials

41

Recruited

19,200+