TERMINATED

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

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Conditions

Ovarian CancerEpithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerPlatinum-resistant Ovarian CancerFOLR1FolRαFRαfolate receptor alphaantibody drug conjugateLuveltamab tazevibulinSTRO-002luvelta

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

Official Title

REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

Quick Facts

Study Start:2023-07-12
Study Completion:2025-08-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05870748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
  2. 2. Age ≥ 18 years
  3. 3. ECOG performance status 0 to 1
  4. 4. Positive FOLR1 expression per central laboratory testing
  5. 5. Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens
  6. 6. Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication
  7. 7. At least 1 measurable target lesion per RECIST v1.1
  8. 8. Adequate organ function
  1. 1. Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas
  2. 2. Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
  3. 3. Primary platinum-refractory disease
  4. 4. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
  5. 5. Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
  6. 6. Previous solid organ transplantation
  7. 7. History or clinical signs of meningeal or active central nervous system involvement
  8. 8. Concurrent participation in another therapeutic treatment trial

Contacts and Locations

Study Locations (Sites)

Arizona Oncology Associates, PC-Hope
Tucson, Arizona, 85711
United States
Sutter Health
Daly City, California, 94015
United States
Scripps Health
San Diego, California, 92103
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Baptist Health South Florida (BHSF) - Miami Cancer Institute
Miami, Florida, 33176
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
USF Research & Innovation
Tampa, Florida, 33612
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, 31405
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
United States
Optimum Clinical Research Group
Albuquerque, New Mexico, 87109
United States
NYU Langone Health
New York, New York, 10016
United States
Good Samaritan Hospital Medical Center
West Islip, New York, 11795
United States
Pitt County Memorial Hospital, Inc. ECU Medical Center
Greenville, North Carolina, 27834
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Ohio State University Center
Columbus, Ohio, 43210
United States
Kettering Health
Kettering, Ohio, 45429
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center
Tulsa, Oklahoma, 74146
United States
Oncology Associates of Oregon, PC
Eugene, Oregon, 97401
United States
Providence Gynecologic Oncology Clinic
Portland, Oregon, 97213-2933
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Oncology
Dallas, Texas, 75231
United States
Texas Oncology-DFW
Dallas, Texas, 75246
United States
Texas Oncology-San Antonio
San Antonio, Texas, 78240
United States
Baylor Scott & White Medical Center - Temple (Temple Clinic)
Temple, Texas, 76508
United States
Texas Oncology - The Woodlands
The Woodlands, Texas, 77380
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Virginia Mason Medical Center - Digestive Disease Institute - Liver Center
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Sutro Biopharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-12
Study Completion Date2025-08-26

Study Record Updates

Study Start Date2023-07-12
Study Completion Date2025-08-26

Terms related to this study

Keywords Provided by Researchers

  • FOLR1
  • FolRα
  • FRα
  • folate receptor alpha
  • antibody drug conjugate
  • Luveltamab tazevibulin
  • STRO-002
  • luvelta

Additional Relevant MeSH Terms

  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Platinum-resistant Ovarian Cancer