FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.
Summary
This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Arms & interventions
- DrugSofetabart Mipitecan
Administered IV
- DrugPaclitaxel
Administered IV
- DrugTopotecan
Administered IV
- DrugGemcitabine
Administered IV
- DrugPegylated liposomal doxorubicin (PLD)
Administered IV
- DrugMIRV
Administered IV
- DrugBevacizumab
Administered IV
- DrugCarboplatin
Administered IV
Outcome measures
Primary
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)
Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)
Secondary
Overall Survival (OS)
Time frame: Randomization to date of death from any cause (up to 70 months)
PFS
Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)
Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Time frame: Randomization to disease progression or death (up to 70 months)
Duration of Response (DOR)
Time frame: Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)
Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
Time frame: Randomization to disease progression or death from any cause (up to 70 months)
PFS2
Time frame: Randomization to disease progression on next line of treatment or death from any cause (up to 70 months)
Time to Initiation of First Subsequent Systemic Anticancer Therapy or Death (TNTD)
Time frame: Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months)
Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG)
Time frame: Randomization to 30 days post treatment discontinuation
Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5)
Time frame: Randomization to 30 days post treatment discontinuation
Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28)
Time frame: Randomization to 30 days post treatment discontinuation
Change from Baseline in Overall Health-related Quality of Life (HRQoL), as measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale
Time frame: Randomization to 30 days post treatment discontinuation
Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156
Time frame: Randomization through end of treatment (up to 70 months)]
PFS
Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)
Eligibility criteria
Study locations (83)
University of Alabama at Birmingham
Birmingham, Alabama, 35233
HonorHealth
Phoenix, Arizona, 85016
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank, California, 91505
City of Hope, Duarte
Duarte, California, 91010
City of Hope Lennar
Irvine, California, 92618
Moores Cancer Center
La Jolla, California, 92093
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California, 90095
Stanford Women's Cancer Center
Palo Alto, California, 94305
Kaiser Permanente Zion Medical Center
San Diego, California, 92120
Sansum Clinic
Santa Barbara, California, 93105
Kaiser Permanente
Vallejo, California, 94589
Anschutz Cancer Pavilion
Aurora, Colorado, 80045
AdventHealth Medical Group - Porter
Denver, Colorado, 80210
UConn Health
Farmington, Connecticut, 06030-8010
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Florida Cancer Specialist- South
Fort Myers, Florida, 33901
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Mount Sinai Braman Comprehensive Cancer Center
Miami Beach, Florida, 33140
AdventHealth Orlando
Orlando, Florida, 32803
Moffitt Cancer Center
Tampa, Florida, 33612
Florida Cancer Specialist- East
West Palm Beach, Florida, 33401
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah, Georgia, 31405
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
The University of Chicago Medicine
Chicago, Illinois, 60637
OSF Saint Fracis Medical Center
Peoria, Illinois, 61637
Franciscan Health
Indianapolis, Indiana, 46237
Baptist Health Lexington
Lexington, Kentucky, 40503
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Trials 365
Shreveport, Louisiana, 71103
Maine Medical Center - Scarborough Campus
Scarborough, Maine, 04074
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21215
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
Karmanos Cancer Institute
Detroit, Michigan, 48201
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
University of Missouri Hospital
Columbia, Missouri, 65212
HCA Midwest Kansas City, MidAmerica Division, Inc.
Kansas City, Missouri, 64132
Cox Medical Center North
Springfield, Missouri, 65802
The Center of Hope
Reno, Nevada, 89511
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Optimum Clinical Research Group
Albuquerque, New Mexico, 87109
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Duke Cancer Institute
Durham, North Carolina, 27710
Miami Valley Hospital South
Centerville, Ohio, 45459
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210
The Mark H Zangmeister Center
Columbus, Ohio, 43219
ProMedica Flower Hospital
Sylvania, Ohio, 43560
USO - Oncology Associates of Oregon, P. C.
Eugene, Oregon, 97401
Providence Portland Medical Center
Portland, Oregon, 97213
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
Oregon Health and Science University
Portland, Oregon, 97239
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Women & Infants Hospital
Providence, Rhode Island, 02905
Medical University of South Carolina
Charleston, South Carolina, 29425
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
USO-Texas Oncology-Central/South Texas
Austin, Texas, 78731
UT Southwestern Medical Center
Dallas, Texas, 75390
US Oncology
The Woodlands, Texas, 77380
US Oncology
The Woodlands, Texas, 77380
USO - Texas Oncology Gulf Coast
Webster, Texas, 77598-4420
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Swedish Medical Center
Seattle, Washington, 98104
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792