Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer
RAINFOL-02
A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer
7 other identifiers
interventional
530
17 countries
173
Brief Summary
This phase 3 study will be conducted in different countries all over the world. The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2025
Typical duration for phase_3
173 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
February 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2028
April 29, 2026
April 1, 2026
2 years
September 20, 2024
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Up to approximately 1.5 years
Secondary Outcomes (11)
Overall Survival (OS)
Up to approximately 1.5 years
Objective Response Rate (ORR)
Up to approximately 1.5 years
PFS as Determined by BICR
Up to approximately 1.5 years
ORR as Determined by BICR
Up to approximately 1.5 years
Duration of Response (DOR)
Up to approximately 1.5 years
- +6 more secondary outcomes
Study Arms (2)
Rina-S
EXPERIMENTALInvestigator's Choice
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Participants may be enrolled regardless of FRα expression level.
- Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
- Participants must have received prior treatment with the following therapies:
- Platinum chemotherapy
- Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
- Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
- Mirvetuximab soravtansine, if:
- Mirvetuximab soravtansine is available in the enrollment region, and
- The participant is eligible, and
- The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
- Participants must have platinum-resistant disease:
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \> 91 days and ≤ 183 days after the date of the last dose of platinum.
- Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.
You may not qualify if:
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
- History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
- Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmablead
Study Sites (177)
Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
Arizona Center for Cancer Care (ACCC) - Biltmore
Scottsdale, Arizona, 85251, United States
University of Arizona Cancer Center - Research and Administration at Main Campus
Tucson, Arizona, 85724, United States
Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
Burbank, California, 91505, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093, United States
USCF Mission Bay
San Francisco, California, 94158, United States
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, 94589, United States
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Norwalk Hospital
Norwalk, Connecticut, 06850, United States
SCRI - Florida Cancer Specialists - South Region Research Office
Fort Myers, Florida, 33901-8108, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Orlando Health Cancer Institute - Downtown Orlando
Orlando, Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
SCRI - Florida Cancer Specialists - West Palm Beach
West Palm Beach, Florida, 33401, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Northside Hospital Atlanta
Atlanta, Georgia, 30342, United States
Augusta University Georgia Cancer Center
Augusta, Georgia, 30912, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Northwest Cancer Center - Dyer
Dyer, Indiana, 46311, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
HCA Midwest Health
Overland Park, Kansas, 66211, United States
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky, 41017, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Louisiana State University Health Sciences Center (LSU Health) - New Orleans
New Orleans, Louisiana, 70112, United States
Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
Shreveport, Louisiana, 71103, United States
Maine Medical Center Cancer Institute- Scarborough
Scarborough, Maine, 04074-7172, United States
Holy Cross Health - Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Corewell Health (Spectrum Health)
Grand Rapids, Michigan, 49503, United States
Saint Joseph Mercy Ann Arbor Hospital
Ypsilanti, Michigan, 48197, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
Center of Hope
Reno, Nevada, 89511, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203, United States
Perlmutter Cancer Center - 38th Street
New York, New York, 10016, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York, 10016, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
New York-Presbyterian - Weill Cornell Medical Center
New York, New York, 10065, United States
James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Duke Cancer Institute
Durham, North Carolina, 27705, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio, 43026, United States
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210, United States
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Allegheny Health Network - West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Jefferson Health - Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
Abilene, Texas, 79606, United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
Austin, Texas, 78731, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
Fort Worth, Texas, 76104, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
USOR - Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502, United States
Kadlec Clinic - Hematology and Oncology
Kennewick, Washington, 99336, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506-9600, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53706, United States
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia
Icon Cancer Centre
South Brisbane, Queensland (qld), 4101, Australia
Mater Misericordiae - Mater Hospital Brisbane
South Brisbane, Australia
Saint John of God - Subiaco Hospital
Subiaco, 6008, Australia
Krankenhaus Hietzing
Vienna, State of Vienna, 1130, Austria
Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Upper Austria (Oberösterreich), 4010, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
Turnhout, Antwerp, 2300, Belgium
AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
Aalst, 9300, Belgium
Centre Hospitalier Universitaire Saint-Pierre
Brussels, 1000, Belgium
Grand Hôpital de Charleroi - Site Les Viviers
Charleroi, 6000, Belgium
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Chretien - Clinique MontLégia
Liège, 4000, Belgium
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, 051237111, Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X0C1, Canada
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto, M4Y 3M5, Canada
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710049, China
The First Hospital of Jilin University
Changchun, 130021, China
Zhejiang Cancer Hospital
Hanzhou, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Henan Cancer Hospital - Zhengzhou University
Zhengzhou, China
University Hospital Královské Vinohrady
Prague, Prague, Czechia
Masaryk Memorial Cancer Institute
Brno, 60200, Czechia
Fakultní Nemocnice Hradec Králové
Hradec Králové, 50005, Czechia
Nemocnice AGEL Nový Jičín a.s.
Nový Jičín, 74101, Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, 12808, Czechia
Fakultni nemocnice v Motole
Prague, 15000, Czechia
Bulovka University Hospital
Prague, 18000, Czechia
Aalborg Universitetshospital
Aalborg, 9000, Denmark
The Royal Hospital (Rigshospitalet)
Copenhagen, Denmark
Odense Universitets Hospital
Odense, 5000, Denmark
Centre Antoine Lacassagne
Nice, 6189, France
Hôpital Européen Georges-Pompidou
Paris, 75015, France
Hospital Lyon-Sud (HCL)
Pierre-Bénite, 69310, France
Centre Eugène Marquis
Rennes, 35042, France
Western Cancer Institute - Saint-Herblain - René Gauducheau Site
Saint-Herblain, 44800, France
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94805, France
Helios Klinikum Berlin-Buch
Berlin, 13125, Germany
University Hospital Bonn
Bonn, 53127, Germany
University Hospital Carl Gustav Carus Dresden
Dresden, 01307, Germany
University Hospital of Düsseldorf
Düsseldorf, 40225, Germany
Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
Essen, 45136, Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, 60596, Germany
Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
Giessen, 35392, Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, 20357, Germany
MVZ Onko Medical GmbH Hanover
Hanover, 30449, Germany
University Hospital Heidelberg /Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
UniversitY Hospital of Saarland
Homburg, 66421, Germany
Red Cross Hospital Munich
Munich, 80634, Germany
Universitätsklinikum Münster/University Clinic Muenster
Münster, 48149, Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199, Germany
General Hospital of Athens
Athens, 11527, Greece
Attikon University General Hospital/General Hospital of West Attica
Chaïdári, 12462, Greece
Aretaieio Hospital
Léfkos, 2024, Greece
Saint Luke's Hospital
Panórama, Greece
Azienda Sanitaria Locale Brindisi
Brindisi, Apulia, 72100, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo di Oncologia/ European Institute of Oncology
Milan, 20141, Italy
Humanitas San Pio X
Milan, 20159, Italy
Local Health Authority of Biella - Nuovo Ospedale degli Infermi
Ponderano, 13875, Italy
Agostino Gemelli University Hospital Foundation IRCCS
Roma, 00168, Italy
Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau
Torino, 10128, Italy
Aichi Cancer Center
Nagoya, Aichi Pref, 4648681, Japan
Kurume University Hospital
Kurume, Fukuoka Pref, 8300011, Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, 0300804, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa Pref, 2160015, Japan
Tohoku University Hospital
Sendai, Miyagi Pref, 9808574, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata Pref, 9518520, Japan
Okayama University Hospital
Okayama, Okayama Pref., 7008558, Japan
Saitama Medical University - International Medical Center
Hidaka, Saitama Pref., 350-1298, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka Pref., 4118777, Japan
Jichi Medical University Hospital
Saitama, Tochigi Pref., 329-0498, Japan
The Jikei University Hospital
Minato, Tokyo, 105-0003, Japan
Ehime University Hospital
Shibukawa, Toon City, Ehime Pref, 791-0295, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Amsterdam UMC, location VUmc
Amsterdam, 1081 HV, Netherlands
Medisch Spectrum Twente - Enschede Koningsplein
Enschede, 7512 AV, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333, Netherlands
Maastricht (UMC) Universitair Medisch Centrum
Maastricht, 6229, Netherlands
Erasmus MC/ Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Oslo Universitetssykehus - Radiumhospitalet
Oslo, 0379, Norway
University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
Tromsø, 9019, Norway
Jagiellońskie Centrum Innowacj
Krakow, Lesser Poland (Małopolskie), 30-348, Poland
Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
Bialystok, 15-027, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, 80-211, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Poznan, 61-867, Poland
Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
Siedlce, 08-110, Poland
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin, 70-111, Poland
UPR Comprehensive Cancer Center Hospital
Monacillo, San Juan, 00927, Puerto Rico
Hospital Universitario de A Coruña
A Coruña, 15006, Spain
Hospital Universitario DE Donostia
Donostia / San Sebastian, 20014, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, 30120, Spain
Hospital Universitario La Paz
Madrid, 28029, Spain
MD Anderson Cancer Center Madrid
Madrid, 28033, Spain
Virgen del Rocío University Hospital
Seville, 41013, Spain
IVO - Valencian Institute of Oncology Foundation
Valencia, 46009, Spain
Miguel Servet Hospital
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Official
Genmab
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2024
First Posted
October 1, 2024
Study Start
February 7, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
May 23, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share