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
Public ClinicalTrials.gov record NCT05870748. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05870748
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Interventions
- Luveltamab tazevibulin Drug
- Pegfilgrastim Drug
- Gemcitabine Drug
- Paclitaxel Drug
- Pegylated liposomal doxorubicin Drug
- Topotecan Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2023 (Actual)
- Primary completion
- Aug 26, 2025 (Actual)
- Completion
- Aug 26, 2025 (Actual)
- Last update posted
- Sep 23, 2025
2023 – 2025
United States locations
- U.S. sites
- 37
- U.S. states
- 20
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, PC-Hope | Tucson | Arizona | 85711 | — |
| Sutter Health | Daly City | California | 94015 | — |
| Scripps Health | San Diego | California | 92103 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Baptist Health South Florida (BHSF) - Miami Cancer Institute | Miami | Florida | 33176 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| USF Research & Innovation | Tampa | Florida | 33612 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | 31405 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | — |
| Minnesota Oncology Hematology | Minneapolis | Minnesota | 55404 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Optimum Clinical Research Group | Albuquerque | New Mexico | 87109 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Good Samaritan Hospital Medical Center | West Islip | New York | 11795 | — |
| Pitt County Memorial Hospital, Inc. ECU Medical Center | Greenville | North Carolina | 27834 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| Ohio State University Center | Columbus | Ohio | 43210 | — |
| Kettering Health | Kettering | Ohio | 45429 | — |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | — |
| Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center | Tulsa | Oklahoma | 74146 | — |
| Oncology Associates of Oregon, PC | Eugene | Oregon | 97401 | — |
| Providence Gynecologic Oncology Clinic | Portland | Oregon | 97213-2933 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | — |
| Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology | Dallas | Texas | 75231 | — |
| Texas Oncology-DFW | Dallas | Texas | 75246 | — |
| Texas Oncology-San Antonio | San Antonio | Texas | 78240 | — |
| Baylor Scott & White Medical Center - Temple (Temple Clinic) | Temple | Texas | 76508 | — |
| Texas Oncology - The Woodlands | The Woodlands | Texas | 77380 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Virginia Mason Medical Center - Digestive Disease Institute - Liver Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05870748, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2025 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05870748 live on ClinicalTrials.gov.