Recurrent, Platinum-Sensitive Ovarian Cancer MedDRA version: 21.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Mersana Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion 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) -Maintenance therapy (e.g., bevacizumab, PARPi, endocrine therapy) will be considered as part of the preceding line of therapy (i.e., not counted independently) - Therapy given for only 1 cycle and discontinued due to toxicity in the absence of progression will not be counted as a new line of therapy; therapy given for 2 or more cycles will be counted as a line of therapy. Substitutions of different platinum agents or taxanes will not be counted as new lines. -Hormonal therapy (e.g., tamoxifen, letrozole) will be counted as a separate line of therapy unless given as maintenance. d. In Italy and Norway, participants must have exhausted or be ineligible for the treatment options approved for maintenance treatment of recurrent, platinum sensitive HGSOC. 7. Participant must have had as their best response to last line of treatment one of the following: No Evidence of Disease (NED); Complete Response (CR); Partial Response (PR); OR Stable Disease (SD) 8. Participants with NED, CR, or PR as their best response to most recent line of treatment and who have not received treatment with a prior PARP inhibitor must have definitive BRCA1 and BRCA2 testing results that demonstrate no evidence of a deleterious BRCA1 or BRCA2 mutation. Somatic BRCA mutation testing is required for participants who are classified as not having a deleterious mutation by germline testing alone. 9. Participant must provide either a tumor tissue block or fresh cut slides for measurement of NaPi2b expression by a central laboratory. If sufficient archival tumor tissue is not available, then a tumor tissue block or slides must be obtained from a fresh biopsy and provided to the central laboratory. Confirmation of a NaPi2b-H/positive tumor by the central laboratory is required prior to randomization. 10. Participants with toxicity from prior therapy or surgical procedures must have recovered to Grade =1. Participants with alopecia, stable immune
Exclusion criteria
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 1: repeated demonstration of a QTcF interval >480 milliseconds (ms) using Fridericia's QT correction formula. - A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). 15. Has a diagnosis of additional malignancy that required treatm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate superiority in Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 of upifitamab rilsodotin versus placebo as maintenance therapy;Secondary Objective: Key Secondary Objective: • Compare Overall Survival (OS) of upifitamab rilsodotin versus placebo as maintenance therapy Other Secondary Objectives: • Compare PFS as assessed by Investigator using RECIST v1.1 of upifitamab rilsodotin versus placebo as maintenance therapy • Compare the Objective Response Rate (ORR) as assessed by Investigator using RECIST v1.1 of upifitamab rilsodotin versus placebo as maintenance therapy • Evaluate safety and tolerability in participants treated with upifitamab rilsodotin versus placebo as maintenance therapy;Primary end point(s): Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) ;Timepoint(s) of evaluation of this end point: Every 6 weeks and then every 12 weeks until disease progression or start of a new therapy, assessed up to an average of 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Assessment of overall survival (OS) - Investigator determined PFS - Overall Safety - Investigator determined Objective Response Rate (ORR) ;Timepoint(s) of evaluation of this end point: - OS: Duration of treatment, continuing every 90 days following completion of treatment, up to an average of 4 years - Investigator determined PFS: Every 6 weeks and then every 12 weeks until disease progression or start of a new therapy, assessed up to an average of 12 months. - Overall safety: Up to 60 days past last dose - Investigator determined ORR: Every 6 weeks and then every 12 weeks until disease progression or start of a new therapy, assessed up to an average of 12 months. | — |
Countries
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Norway, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactMedical Information
Mersana Therapeutics, Inc.
Outcome results
None listed