A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants with Recurrent, Platinum-Sensitive Ovarian Cancer (UP-NEXT)

Mersana Therapeutics, Inc.0 sites581 target enrollmentJuly 19, 2022

ConditionsRecurrent, Platinum-Sensitive Ovarian Cancer MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent, Platinum-Sensitive Ovarian Cancer
Sponsor: Mersana Therapeutics, Inc.
Enrollment: 581
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 19, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Mersana Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•1\.Participants must be at least 18 years of age, and female.
•2\.Participant must have an ECOG performance status 0 or 1
•3\.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.
•4\.Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
•5\.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.
•6\.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:
•a. Platinum\-based chemotherapy regimens allowed immediately preceding enrollment to the study: carboplatin or cisplatin ±: paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine.
•b. 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.
•c. Definitions for prior lines of therapy:
•\-Adjuvant ± neoadjuvant considered one line of therapy as long as they are the same regimens (e.g., platinum/taxane for 4 cycles before surgery followed by platinum/taxane for 4 cycles after surgery)

Exclusion Criteria

•1\. Participant has received prior treatment with mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload.
•2\. Participant has received bevacizumab in combination with last platinum\-based regiment or plans to receive maintenance therapy outside the study intervention.
•3\. Participant has clinical signs or symptoms of gastrointestinal obstruction and/or requirement for parenteral hydration or nutrition.
•4\. Participant has ascites or pleural effusion managed with therapeutic paracentesis or thoracentesis within 28 days prior to signing the principal study consent form.
•5\. Participant has history of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease. Testing beyond laboratory studies otherwise defined in the eligibility criteria, to diagnose potentially clinically significant liver disease based on risk factors such as hepatic steatosis or history of excessive alcohol intake, will be based on clinical judgement of the investigator.
•6\. Participants cannot receive drugs associated with hepatotoxicity concurrent with upifitamab rilsodotin administration except as outlined in Appendix 4\.
•7\. Participant currently uses either constant or intermittent supplementary oxygen therapy.
•8\. Participant has history of or suspected pneumonitis or interstitial lung disease.
•9\. Participant has oxygen saturation on room air \<93%.
•10\. Participant has had major surgery or systemic anti\-cancer therapy within 28 days of starting study treatment.