FRAmework-01: A Two-Part Phase 3 Study of LY4170156 Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and LY4170156 Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.

Status: Recruiting
Location: See all (135) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a clinical study that has two parts. It is testing a potential new medicine called LY4170156 for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if LY4170156 works better than the usual 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Part A and B:

• Have histologically confirmed high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.

• Have confirmed availability of tumor tissue block or slides

• Have radiographic progression on or after most recent line of systemic anticancer therapy

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

• Have measurable disease per RECIST v1.1

⁃ Part A:

• Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.

• Have previously received greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior therapy is allowed if one of those lines is mirvetuximab soravtansine.

• Have received prior bevacizumab treatment, unless documented contraindication or intolerance.

• Have received treatment with a poly(ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.

⁃ Part B:

• Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy

• Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy

• Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.

Locations
United States
Arizona
HonorHealth
NOT_YET_RECRUITING
Phoenix
California
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
NOT_YET_RECRUITING
Burbank
Sansum Clinic
NOT_YET_RECRUITING
Solvang
Colorado
Anschutz Cancer Pavilion
NOT_YET_RECRUITING
Aurora
Florida
Broward Health Medical Center
NOT_YET_RECRUITING
Fort Lauderdale
Florida Cancer Specialist- South
NOT_YET_RECRUITING
Fort Myers
University of Miami Hospital and Clinics, Sylvester Cancer Center
NOT_YET_RECRUITING
Miami
Mount Sinai Comprehensive Cancer Center
NOT_YET_RECRUITING
Miami Beach
Moffitt Cancer Center
NOT_YET_RECRUITING
Tampa
Florida Cancer Specialist- East
NOT_YET_RECRUITING
West Palm Beach
Hawaii
Kapiolani Medical Center for Women and Children
NOT_YET_RECRUITING
Honolulu
Illinois
Illinois Cancer Specialists
NOT_YET_RECRUITING
Arlington Heights
Northwestern Memorial Hospital
NOT_YET_RECRUITING
Chicago
Kentucky
Baptist Health Lexington
NOT_YET_RECRUITING
Lexington
Norton Women's and Children's Hospital
NOT_YET_RECRUITING
Louisville
Louisiana
Trials 365
RECRUITING
Shreveport
Massachusetts
University of Massachusetts Chan Medical School
NOT_YET_RECRUITING
Worcester
Maryland
Greater Baltimore Medical Center
NOT_YET_RECRUITING
Baltimore
Sinai Hospital Of Baltimore
NOT_YET_RECRUITING
Baltimore
Maine
Maine Medical Center - Scarborough Campus
NOT_YET_RECRUITING
Scarborough
Michigan
Karmanos Cancer Institute
NOT_YET_RECRUITING
Detroit
West Michigan Cancer Center
NOT_YET_RECRUITING
Kalamazoo
Minnesota
Mayo Clinic in Rochester, Minnesota
NOT_YET_RECRUITING
Rochester
North Carolina
Levine Cancer Institute
NOT_YET_RECRUITING
Charlotte
Duke Cancer Institute
NOT_YET_RECRUITING
Durham
New Jersey
Holy Name Medical Center
NOT_YET_RECRUITING
Teaneck
New Mexico
Optimum Clinical Research Group
NOT_YET_RECRUITING
Albuquerque
New York
Northwell Health/ RJ Zuckerberg Cancer Center
NOT_YET_RECRUITING
Lake Success
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
NOT_YET_RECRUITING
Mineola
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
Laura and Isaac Perlmutter Cancer Center
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Cancer Center
NOT_YET_RECRUITING
New York
Ohio
Miami Valley Hospital South
NOT_YET_RECRUITING
Centerville
Oncology Hematology Care Inc
NOT_YET_RECRUITING
Cincinnati
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
The Mark H Zangmeister Center
NOT_YET_RECRUITING
Columbus
ProMedica Flower Hospital
NOT_YET_RECRUITING
Sylvania
Oregon
USO - Oncology Associates of Oregon, P. C.
NOT_YET_RECRUITING
Eugene
Kaiser Permanente Interstate Medical Office Central
NOT_YET_RECRUITING
Portland
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
Providence Portland Medical Center
NOT_YET_RECRUITING
Portland
Pennsylvania
University of Pennsylvania Hospital
NOT_YET_RECRUITING
Philadelphia
Rhode Island
Women & Infants Hospital
NOT_YET_RECRUITING
Providence
Texas
USO-Texas Oncology-Central/South Texas
NOT_YET_RECRUITING
Austin
US Oncology
NOT_YET_RECRUITING
The Woodlands
USO - Texas Oncology Gulf Coast
NOT_YET_RECRUITING
Webster
Utah
Huntsman Cancer Institute
NOT_YET_RECRUITING
Salt Lake City
Washington
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
Gold Coast University Hospital
NOT_YET_RECRUITING
Southport
Austria
Medizinische Universität Graz
NOT_YET_RECRUITING
Graz
Medizinische Universitaet Innsbruck
NOT_YET_RECRUITING
Innsbruck
Belgium
Institut Jules Bordet
NOT_YET_RECRUITING
Anderlecht
AZ Sint-Jan Brugge-Oostende AV
NOT_YET_RECRUITING
Bruges
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
AZ Maria Middelares
NOT_YET_RECRUITING
Ghent
Brazil
CPAM - Centro de Pesquisas da Amazônia
NOT_YET_RECRUITING
Belém
Oncocentro de Minas Gerais
NOT_YET_RECRUITING
Belo Horizonte
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
NOT_YET_RECRUITING
Florianópolis
Hospital Brasilia
NOT_YET_RECRUITING
Lago Sul
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
NOT_YET_RECRUITING
Rio De Janeiro
Instituto D'Or Pesquisa e Ensino
NOT_YET_RECRUITING
Rio De Janeiro
Clinica Amo - Rio Vermelho
NOT_YET_RECRUITING
Salvador
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
NOT_YET_RECRUITING
São Caetano Do Sul
Canada
Hamilton Health Sciences-Juravinski Cancer Centre
NOT_YET_RECRUITING
Hamilton
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
NOT_YET_RECRUITING
Sherbrooke
BC Cancer Surrey
NOT_YET_RECRUITING
Surrey
Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
Sunnybrook Research Institute
NOT_YET_RECRUITING
Toronto
China
Beijing Cancer hospital
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The First People's Hospital of Changde City
NOT_YET_RECRUITING
Changde
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
West China Second University Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-Sen University Cancer Centre
NOT_YET_RECRUITING
Guangzhou
Zhujiang Hospital
NOT_YET_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Gansu Provincial Maternity and Child Care Hospital
NOT_YET_RECRUITING
Lanzhou
The First Affiliated Hospital of Henan University of Science &Technology
NOT_YET_RECRUITING
Luoyang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Obstetrics & Gynecology Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
NOT_YET_RECRUITING
Shantou
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Wuhan Union Hospital
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
France
Institut de Cancérologie de l'Ouest
NOT_YET_RECRUITING
Angers
CHRU de Brest
NOT_YET_RECRUITING
Brest
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
NOT_YET_RECRUITING
Bologna
Azienda USL 2 Lucca
NOT_YET_RECRUITING
Lucca
Fondazione IRCCS Istituto Nazionale dei Tumori
NOT_YET_RECRUITING
Milan
Ospedale Humanitas San Pio X
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero Universitaria
NOT_YET_RECRUITING
Modena
Nuovo Ospedale di Prato-S.Stefano
NOT_YET_RECRUITING
Prato
Ospedale Santa Maria delle Croci
NOT_YET_RECRUITING
Ravenna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
NOT_YET_RECRUITING
Roma
Japan
National Cancer Center Hospital
NOT_YET_RECRUITING
Chūōku
Saitama Medical University International Medical Center
NOT_YET_RECRUITING
Hidaka
Nagoya University Hospital
NOT_YET_RECRUITING
Nagoya
Niigata Cancer Center Hospital
NOT_YET_RECRUITING
Niigata
Mexico
Scientia Investigacion Clinica S.C.
NOT_YET_RECRUITING
Chihuahua City
Centro de Atención E Investigación Clínica En Oncología
NOT_YET_RECRUITING
Mérida
CENEIT Oncologicos
NOT_YET_RECRUITING
Mexico City
COI Centro Oncologico Internacional S.A.P.I. de C.V.
NOT_YET_RECRUITING
Mexico City
Health Pharma Professional Research S.A. de C.V:
NOT_YET_RECRUITING
Mexico City
Higiea Oncologia
NOT_YET_RECRUITING
Mexico City
INCAN
NOT_YET_RECRUITING
Mexico City
Unidad Médica Onco-hematológica
NOT_YET_RECRUITING
Puebla City
PanAmerican Clinical Research - Querétaro - Avenida Antea
NOT_YET_RECRUITING
Querétaro
Hospital Angeles
NOT_YET_RECRUITING
Tijuana
Centro Oncologico Estatal ISSEMyM ( COEI )
NOT_YET_RECRUITING
Toluca
Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
NOT_YET_RECRUITING
Krakow
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie
NOT_YET_RECRUITING
Poznan
Mazowiecki Szpital Wojewódzki w Siedlcach
NOT_YET_RECRUITING
Siedlce
Republic of Korea
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
National Cancer Center
NOT_YET_RECRUITING
Goyang-si
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
Ajou University Hospital
NOT_YET_RECRUITING
Suwon
Romania
SC Memorial Healthcare International SRL
NOT_YET_RECRUITING
Bucharest
Sc Mnt Healthcare Europe Srl
NOT_YET_RECRUITING
Bucharest
Institutul Regional de Oncologie
NOT_YET_RECRUITING
Iași
S C Oncocenter Oncologie Clinica S R L
NOT_YET_RECRUITING
Timișoara
Switzerland
Kantonsspital Graubünden
NOT_YET_RECRUITING
Chur
Contact Information
Primary
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2031-08
Participants
Target number of participants: 1080
Treatments
Experimental: Part A: LY4170156
Administered intravenously (IV).
Active_comparator: Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)
Investigator's Choice of Chemotherapy or MIRV given IV.
Experimental: Part B: LY4170156 plus Bevacizumab
Administered IV.
Active_comparator: Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab
Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group (APGOT), GOG Foundation

This content was sourced from clinicaltrials.gov

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