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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05329545




Registration number
NCT05329545
Ethics application status
Date submitted
24/03/2022
Date registered
15/04/2022
Date last updated
26/10/2023

Titles & IDs
Public title
Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Scientific title
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)
Secondary ID [1] 0 0
XMT-1536-3
Universal Trial Number (UTN)
Trial acronym
UP-NEXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Grade Serous Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Primary Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upifitimab rilsodotin
Other interventions - Placebo

Experimental: XMT-1536 (upifitamab rilsodotin) - XMT-1536 (upifitamab rilsodotin)

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


Treatment: Drugs: Upifitimab rilsodotin
Upifitimab rilsodotin will be administered once every four weeks until completion, disease progression, unacceptable toxicity, voluntary discontinuation, or death (approximately up to 18 months).

Other interventions: Placebo
Placebo controlled arm.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [1] 0 0
Up to 12 months after the last dose for the last participant.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to an average of 4 years. Follow up assessments for survival data will continue every 90 days following completion of treatment.
Secondary outcome [2] 0 0
Progression-free Survival (PFS) as assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [2] 0 0
Up to 12 months after the last dose for the last participant.
Secondary outcome [3] 0 0
Adverse events (AEs) based on NCI CTCAE Version 5.0
Timepoint [3] 0 0
Up to 60 days past last dose
Secondary outcome [4] 0 0
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
Timepoint [4] 0 0
Up to 60 days past last dose.
Secondary outcome [5] 0 0
Objective Response Rate (ORR) as assessed by Investigator using RECIST Version 1.1
Timepoint [5] 0 0
Up to 12 months after the last dose for the last participant.
Secondary outcome [6] 0 0
Number of participants using concomitant medications
Timepoint [6] 0 0
Up to 60 days past last dose.

Eligibility
Key inclusion criteria
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.

2. 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.

3. 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:

1. Platinum-based chemotherapy regimens allowed immediately preceding enrollment to
the study: carboplatin or cisplatin ±: paclitaxel, docetaxel, pegylated liposomal
doxorubicin or gemcitabine.

2. 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.

4. 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)

5. 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.

6. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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. Participant has history of or suspected pneumonitis or interstitial lung disease.

7. Participant has untreated CNS metastases (including new and progressive brain
metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/09/2023
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Montana
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Canada
State/province [19] 0 0
Sherbrooke

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mersana Therapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05329545
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Burger, MD
Address 0 0
Mersana Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05329545