← Back to Search

XMT-1536 (upifitamab rilsodotin) for Ovarian Cancer (UP-NEXT Trial)

Phase 3
Waitlist Available
Research Sponsored by Mersana Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after the last dose for the last participant.
Awards & highlights

UP-NEXT Trial Summary

This trial is testing a new cancer drug to see if it is effective in treating ovarian cancer.

Eligible Conditions
  • High Grade Serous Ovarian Cancer
  • Ovarian Cancer
  • Peritoneal Cancer

UP-NEXT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after the last dose for the last participant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after the last dose for the last participant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary outcome measures
Adverse events (AEs) based on NCI CTCAE Version 5.0
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants using concomitant medications
+3 more

Side effects data

From 2021 Phase 1 & 2 trial • 331 Patients • NCT02257567
67%
FATIGUE
50%
ALOPECIA
50%
DECREASED APPETITE
50%
CONSTIPATION
50%
NAUSEA
50%
INSOMNIA
33%
HYPOPHOSPHATAEMIA
33%
RASH
33%
NEUTROPENIA
33%
VOMITING
33%
NIGHT SWEATS
33%
DIARRHOEA
33%
WEIGHT DECREASED
33%
HYPERGLYCAEMIA
33%
DYSPNOEA
17%
PLATELET COUNT DECREASED
17%
PRURITUS
17%
ARTHROPOD BITE
17%
SKIN DISCOLOURATION
17%
THROMBOCYTOPENIA
17%
HYPERTENSION
17%
GLAUCOMA
17%
STOMATITIS
17%
CHILLS
17%
FOLLICULITIS
17%
BONE PAIN
17%
HERPES ZOSTER
17%
INFUSION RELATED REACTION
17%
LYMPHOCYTE COUNT DECREASED
17%
HYPOMAGNESAEMIA
17%
HYPOKALAEMIA
17%
NEUROPATHY PERIPHERAL
17%
PERIPHERAL SENSORY NEUROPATHY
17%
EYE PRURITUS
17%
VISION BLURRED
17%
FLATULENCE
17%
SINUSITIS
17%
ENDOMETRIAL ADENOCARCINOMA
17%
ENDOMETRIAL CANCER
17%
ANAEMIA
17%
ABDOMINAL PAIN
17%
MUSCULAR WEAKNESS
17%
COUGH
17%
DYSPNOEA EXERTIONAL
17%
DRY SKIN
17%
MOUTH ULCERATION
17%
PALLOR
17%
EYE DISCHARGE
17%
VITAMIN D DEFICIENCY
17%
SINUS CONGESTION
17%
ATRIAL FIBRILLATION
17%
PYREXIA
17%
DIZZINESS
17%
PERIPHERAL SWELLING
17%
HODGKIN'S DISEASE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
Arm A (Phase II Randomization): Pola+BR in FL
Arm B (Phase II Randomization): BR in FL
Arm C (Phase II Randomization): Pola+BR in DLBCL
Arm D (Phase II Randomization): BR in DLBCL
Arm E (Phase II Expansion): Pola+BG in FL
Arm F (Phase II Expansion): Pola+BG in DLBCL
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

UP-NEXT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: XMT-1536 (upifitamab rilsodotin)Experimental Treatment1 Intervention
XMT-1536 (upifitamab rilsodotin)
Group II: PlaceboPlacebo Group1 Intervention
Saline placebo will be administered with same schedule and stopping rules as for the assigned interventions in the Experimental Arm.

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK
42 Previous Clinical Trials
16,721 Total Patients Enrolled
8 Trials studying Ovarian Cancer
3,279 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
17,219 Total Patients Enrolled
11 Trials studying Ovarian Cancer
5,391 Patients Enrolled for Ovarian Cancer
Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,268 Total Patients Enrolled
2 Trials studying Ovarian Cancer
350 Patients Enrolled for Ovarian Cancer

Media Library

XMT-1536 (upifitamab rilsodotin) Clinical Trial Eligibility Overview. Trial Name: NCT05329545 — Phase 3
Ovarian Cancer Research Study Groups: Placebo, XMT-1536 (upifitamab rilsodotin)
Ovarian Cancer Clinical Trial 2023: XMT-1536 (upifitamab rilsodotin) Highlights & Side Effects. Trial Name: NCT05329545 — Phase 3
XMT-1536 (upifitamab rilsodotin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05329545 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research facilities are handling this project?

"This clinical study is being conducted in 25 cities, which include Chattanooga, Eugene and Las Vegas. To reduce travel burden for participants, it is recommended to select a location closest to the patient."

Answered by AI

Are there any dangers associated with using upifitimab rilsodotin?

"Upifitimab rilsodotin has received a 3 on our team's assessment scale. This is because the drug is currently in Phase 3 clinical trials, meaning that while there isn't extensive data supporting its efficacy, multiple rounds of testing have shown it to be safe."

Answered by AI

What goals does this experiment hope to realize?

"The primary outcome of this clinical trial is progression-free survival (PFS), which will be assessed over a time frame of 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 outcomes include overall safety, changes in Eastern Cooperative Oncology Group (ECOG) performance status, and overall survival (OS)."

Answered by AI

Are there any available openings for this clinical research?

"This particular clinical trial, as indicated on the website clinicaltrials.gov, is still looking for enrollees. The study was first posted on June 23rd, 2020 and has since been updated October 18th of this year."

Answered by AI

How many individuals are being asked to participate in this research project?

"To move forward, this study needs 350 participants that fit the pre-determined inclusion criteria. patients can choose to be seen at Erlanger Womens Oncology in Chattanooga, Tennessee or Willamette Valley Cancer Institute and Research Center in Eugene, Oregon."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
2022. "Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05329545.
~7 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top