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

Last updated: October 24, 2023
Sponsor: Mersana Therapeutics
Overall Status: Terminated

Phase

3

Condition

Fallopian Tube Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

Upifitimab rilsodotin

Placebo

Clinical Study ID

NCT05329545
XMT-1536-3
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 orrecurrent.
  2. Participant must have platinum-sensitive recurrent disease, defined as having achievedeither a partial or complete response to 4 or more cycles in their penultimateplatinum- containing regimen and their disease progressing more than 6 months aftercompletion 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 4thline setting in their most recent treatment regimen as defined below:
  4. Platinum-based chemotherapy regimens allowed immediately preceding enrollment tothe study: carboplatin or cisplatin ±: paclitaxel, docetaxel, pegylated liposomaldoxorubicin or gemcitabine.
  5. Participant must receive first study treatment infusion between 4 and 12 weeksafter completing final dose of platinum in the most recent platinum-basedregimen.
  6. Participant must have had as their best response to last line of treatment one of thefollowing: No Evidence of Disease (NED); Complete Response (CR); Partial Response (PR); OR Stable Disease (SD)
  7. Participants with NED, CR, or PR as their best response to most recent line oftreatment and who have not received treatment with a prior PARP inhibitor must havedefinitive BRCA1 and BRCA2 testing results that demonstrate no evidence of adeleterious BRCA1 or BRCA2 mutation. Somatic BRCA mutation testing is required forparticipants who are classified as not having a deleterious mutation by germlinetesting alone.
  8. Participant must provide either a tumor tissue block or fresh cut slides formeasurement of NaPi2b expression by a central laboratory. If sufficient archival tumortissue is not available, then a tumor tissue block or slides must be obtained from afresh biopsy and provided to the central laboratory. Confirmation of aNaPi2b-H/positive tumor by the central laboratory is required prior to randomization.

Exclusion

Exclusion Criteria:

  1. Participant has received prior treatment with mirvetuximab soravtansine or another ADCcontaining an auristatin or maytansinoid payload.
  2. Participant has received bevacizumab in combination with last platinum-based regimentor plans to receive maintenance therapy outside the study intervention.
  3. Participant has clinical signs or symptoms of gastrointestinal obstruction and/orrequirement for parenteral hydration or nutrition.
  4. Participant has ascites or pleural effusion managed with therapeutic paracentesis orthoracentesis 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 studiesotherwise defined in the eligibility criteria, to diagnose potentially clinicallysignificant liver disease based on risk factors such as hepatic steatosis or historyof 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 brainmetastases), history of leptomeningeal metastasis, or carcinomatous meningitis.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Upifitimab rilsodotin
Phase: 3
Study Start date:
June 23, 2022
Estimated Completion Date:
September 29, 2023

Study Description

This is a multi-center randomized study of XMT-1536 (upifitamab rilsodotin) in patients with tumors expressing high levels of NaPi2b, focusing on patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer. The randomized study design is a double-blind, placebo-controlled study, with a randomization ratio of 2:1. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Participants must have had 4 to 8 cycles of platinum-based chemotherapy in their most recent treatment regimen, including carboplatin or cisplatin ± paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine in the 2nd-4th line setting for the treatment of platinum-sensitive recurrent disease, with no evidence of disease (NED)/complete response (CR)/partial response (PR)/ or stable disease (SD) as best response.

Connect with a study center

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • Icon Cancer Centre - Chermside

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Icon Cancer Centre Southport

    Southport, Queensland 4125
    Australia

    Site Not Available

  • Epworth Richmond

    Richmond, Victoria 3121
    Australia

    Site Not Available

  • CHUM - University of Montreal Hospital Centre

    Montréal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Sherbrooke University Hospital Centre

    Quebec, Sherbrooke J1H 5N4
    Canada

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • HonorHealth Research Institute - HonorHealth VGPCC Biltmore

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • The University of Arizona Cancer Center

    Tucson, Arizona 85719
    United States

    Site Not Available

  • University of California Los Angeles, Gynecologic Oncology Clinic

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Miami Valley Hospital South

    Miami, Florida 45459
    United States

    Site Not Available

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Orlando Health, Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Gyne Oncology Clinic

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Community Health Network, Community Cancer Center North

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • WK Physicians

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Maine Medical Partners, Division of Gynecologic Oncology

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Greater Baltimore Medical Center

    Towson, Maryland 21204
    United States

    Site Not Available

  • Mersana Therapeutics

    Cambridge, Massachusetts 02139
    United States

    Site Not Available

  • Karmanos Cancer Institute - Detroit

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • MidAmerica Division, Inc., c/o Research Medical Center

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Washington University School of Medicine, Center for Advanced Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Cox Medical Centers, GYN ONC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Billings Clinic

    Billings, Montana 59101
    United States

    Site Not Available

  • Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Center of Hope

    Reno, Nevada 89433
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Hackensack University Medical Center, John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Holy Name Medical Center

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Southwest Women's Oncology

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York 10016
    United States

    Site Not Available

  • The Blavatnik Family at Chelsea Medical Center at Mount Sinai

    New York, New York 10011
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Vidant Cancer Center - at Vidant Medical Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic - Cleveland

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • OSU Gynecologic Oncology at Mill Run

    Hilliard, Ohio 43026
    United States

    Site Not Available

  • Kettering Health Cancer Center

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Legacy Good Samaritan Medical Center - Legacy Medical Group - Gynecologic Oncology

    Portland, Oregon 97210
    United States

    Site Not Available

  • Northwest Cancer Specialists PC

    Portland, Oregon 97227
    United States

    Site Not Available

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allegheny Health Network Cancer Institute, West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Women and Infants Hospital

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Hollings Cancer Center (HCC)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Avera McKennan d/b/a Avera Research Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sanford Gynecologic Oncology

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • Erlanger Womens Oncology

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Texas Oncology P.A. - Austin

    Austin, Texas 78745
    United States

    Site Not Available

  • Texas Oncology - DFWW

    Bedford, Texas 76022
    United States

    Site Not Available

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas 76006
    United States

    Site Not Available

  • Texas Oncology P.A. - McAllen

    McAllen, Texas 78503
    United States

    Site Not Available

  • Texas Oncology - Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

  • VCU Massey Cancer Center

    Richmond, Virginia 23291
    United States

    Site Not Available

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.