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AzTrials

Platinum-resistant Ovarian CancerPhase 3RAINFOL-02NCT06619236

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

A Phase 3 study testing Rina-S, Paclitaxel and Topotecan in people with Platinum-resistant Ovarian Cancer, run by Genmab at 177 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer
What is being tested?
Rina-S, Paclitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
584 participants
Where
177 sitesin 18 countries
Study dates
7 Feb 2025to Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
  • NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

177 sites in 18 countries.

177 sites in 18 countries

United States72 sites

  • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene

    Abilene, Texas, 79606

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital Atlanta

    Atlanta, Georgia, 30342

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912

  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central

    Austin, Texas, 78731

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203

  • Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center

    Burbank, California, 91505

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Cancer Institute

    Durham, North Carolina, 27705

  • Northwest Cancer Center - Dyer

    Dyer, Indiana, 46311

  • St. Elizabeth Healthcare - Edgewood

    Edgewood, Kentucky, 41017

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • SCRI - Florida Cancer Specialists - South Region Research Office

    Fort Myers, Florida, 33901-8108

  • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth

    Fort Worth, Texas, 76104

  • Corewell Health (Spectrum Health)

    Grand Rapids, Michigan, 49503

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • JamesCare Gynecologic Oncology at Mill Run

    Hilliard, Ohio, 43026

  • Kapi'olani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kadlec Clinic - Hematology and Oncology

    Kennewick, Washington, 99336

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53706

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506-9600

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Louisiana State University Health Sciences Center (LSU Health) - New Orleans

    New Orleans, Louisiana, 70112

  • Perlmutter Cancer Center - 38th Street

    New York, New York, 10016

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • New York-Presbyterian - Weill Cornell Medical Center

    New York, New York, 10065

  • USOR - Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

  • Norwalk Hospital

    Norwalk, Connecticut, 06850

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Orlando Health Cancer Institute - Downtown Orlando

    Orlando, Florida, 32806

  • HCA Midwest Health

    Overland Park, Kansas, 66211

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Allegheny Health Network - West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Legacy Good Samaritan Medical Center

    Portland, Oregon, 97210

  • USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Center of Hope

    Reno, Nevada, 89511

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • USCF Mission Bay

    San Francisco, California, 94158

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Maine Medical Center Cancer Institute- Scarborough

    Scarborough, Maine, 04074-7172

  • Arizona Center for Cancer Care (ACCC) - Biltmore

    Scottsdale, Arizona, 85251

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Trials365, LLC (Gynecologic Oncology Associates-Shreveport)

    Shreveport, Louisiana, 71103

  • Holy Cross Health - Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • University of Arizona Cancer Center - Research and Administration at Main Campus

    Tucson, Arizona, 85724

  • Kaiser Permanente - Vallejo Medical Center

    Vallejo, California, 94589

  • SCRI - Florida Cancer Specialists - West Palm Beach

    West Palm Beach, Florida, 33401

  • Jefferson Health - Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

  • Saint Joseph Mercy Ann Arbor Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany14 sites

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • University Hospital Bonn

    Bonn, 53127

  • University Hospital Carl Gustav Carus Dresden

    Dresden, 01307

  • University Hospital of Düsseldorf

    Düsseldorf, 40225

  • Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung

    Essen, 45136

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt, 60596

  • Universitätsklinikum Gießen und Marburg - Gießen (UKGM)

    Giessen, 35392

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg, 20357

  • MVZ Onko Medical GmbH Hanover

    Hanover, 30449

  • University Hospital Heidelberg /Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • UniversitY Hospital of Saarland

    Homburg, 66421

  • Red Cross Hospital Munich

    Munich, 80634

  • Universitätsklinikum Münster/University Clinic Muenster

    Münster, 48149

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

Other trials in Germany

Japan14 sites

  • Saitama Medical University - International Medical Center

    Hidaka, Saitama Pref., 350-1298

  • St. Marianna University Hospital

    Kawasaki, Kanagawa Pref, 2160015

  • Kurume University Hospital

    Kurume, Fukuoka Pref, 8300011

  • The Jikei University Hospital

    Minato, Tokyo, 105-0003

  • Shizuoka Cancer Center

    Nagaizumi-chō, Shizuoka Pref., 4118777

  • Aichi Cancer Center

    Nagoya, Aichi Pref, 4648681

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata Pref, 9518520

  • Okayama University Hospital

    Okayama, Okayama Pref., 7008558

  • Jichi Medical University Hospital

    Saitama, Tochigi Pref., 329-0498

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 0300804

  • Tohoku University Hospital

    Sendai, Miyagi Pref, 9808574

  • Ehime University Hospital

    Shibukawa, Toon City, Ehime Pref, 791-0295

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Spain8 sites

  • Hospital Universitario de A Coruña

    A Coruña, 15006

  • Hospital Universitario DE Donostia

    Donostia / San Sebastian, 20014

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital Universitario La Paz

    Madrid, 28029

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Virgen del Rocío University Hospital

    Seville, 41013

  • IVO - Valencian Institute of Oncology Foundation

    Valencia, 46009

  • Miguel Servet Hospital

    Zaragoza, 50009

Other trials in Spain

Belgium7 sites

  • AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst

    Aalst, 9300

  • Centre Hospitalier Universitaire Saint-Pierre

    Brussels, 1000

  • Grand Hôpital de Charleroi - Site Les Viviers

    Charleroi, 6000

  • Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Chretien - Clinique MontLégia

    Liège, 4000

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Roeselare, 051237111

  • Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth

    Turnhout, Antwerp, 2300

Other trials in Belgium

China7 sites

  • The First Hospital of Jilin University

    Changchun, 130021

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital

    Hanzhou

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710049

  • Henan Cancer Hospital - Zhengzhou University

    Zhengzhou

Other trials in China

Czechia7 sites

  • Masaryk Memorial Cancer Institute

    Brno, 60200

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 50005

  • Nemocnice AGEL Nový Jičín a.s.

    Nový Jičín, 74101

  • University Hospital Královské Vinohrady

    Prague, Prague

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 12808

  • Fakultni nemocnice v Motole

    Prague, 15000

  • Bulovka University Hospital

    Prague, 18000

Other trials in Czechia

France7 sites

  • Centre Antoine Lacassagne

    Nice, 6189

  • Hôpital Européen Georges-Pompidou

    Paris, 75015

  • Hospital Lyon-Sud (HCL)

    Pierre-Bénite, 69310

  • Centre Eugène Marquis

    Rennes, 35042

  • Western Cancer Institute - Saint-Herblain - René Gauducheau Site

    Saint-Herblain, 44800

  • Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy7 sites

  • Azienda Sanitaria Locale Brindisi

    Brindisi, Apulia, 72100

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo di Oncologia/ European Institute of Oncology

    Milan, 20141

  • Humanitas San Pio X

    Milan, 20159

  • Local Health Authority of Biella - Nuovo Ospedale degli Infermi

    Ponderano, 13875

  • Agostino Gemelli University Hospital Foundation IRCCS

    Roma, 00168

  • Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau

    Torino, 10128

Other trials in Italy

Poland7 sites

  • Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku

    Bialystok, 15-027

  • Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdansk, 80-211

  • Jagiellońskie Centrum Innowacj

    Krakow, Lesser Poland (Małopolskie), 30-348

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

    Poznan, 61-867

  • Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach

    Siedlce, 08-110

  • Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie

    Szczecin, 70-111

Other trials in Poland

Austria5 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Medizinische Universität Innsbruck

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, Upper Austria (Oberösterreich), 4010

  • Krankenhaus Hietzing

    Vienna, State of Vienna, 1130

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Netherlands5 sites

  • Amsterdam UMC, location VUmc

    Amsterdam, 1081 HV

  • Medisch Spectrum Twente - Enschede Koningsplein

    Enschede, 7512 AV

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333

  • Maastricht (UMC) Universitair Medisch Centrum

    Maastricht, 6229

  • Erasmus MC/ Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

Australia4 sites

  • Newcastle Private Hospital

    New Lambton Heights, New South Wales

  • Icon Cancer Centre

    South Brisbane, Queensland (qld), 4101

  • Mater Misericordiae - Mater Hospital Brisbane

    South Brisbane

  • Saint John of God - Subiaco Hospital

    Subiaco, 6008

Other trials in Australia

Greece4 sites

  • General Hospital of Athens

    Athens, 11527

  • Attikon University General Hospital/General Hospital of West Attica

    Chaïdári, 12462

  • Aretaieio Hospital

    Léfkos, 2024

  • Saint Luke's Hospital

    Panórama

Other trials in Greece

Canada3 sites

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X0C1

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G2M9

  • Sunnybrook Health Sciences Centre - Bayview Campus

    Toronto, M4Y 3M5

Other trials in Canada

Denmark3 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • The Royal Hospital (Rigshospitalet)

    Copenhagen

  • Odense Universitets Hospital

    Odense, 5000

Other trials in Denmark

Norway2 sites

  • Oslo Universitetssykehus - Radiumhospitalet

    Oslo, 0379

  • University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø

    Tromsø, 9019

Other trials in Norway

Puerto Rico1 site

  • UPR Comprehensive Cancer Center Hospital

    Monacillo, San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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

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.

Read the detailed description

The China extension-study of GCT1184-02 is registered under NCT07604766.

Being tested
Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin (PLD), Gemcitabine
Keywords
antibody-drug conjugate, folate receptor alpha (FRα), ovarian cancer, fallopian tube cancer, primary peritoneal cancer, folate receptor, platinum-resistant ovarian cancer (PROC), rinatabart sesutecan, Topoisomerase 1 inhibitor, PRO1184, GEN1184
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rina-SDrug

    Also called PRO1184, Rinatabart Sesutecan, GEN1184

    Intravenous (IV) infusion

  • PaclitaxelDrug

    IV infusion

  • TopotecanDrug

    IV infusion

  • Pegylated liposomal doxorubicin (PLD)Drug

    IV infusion

  • GemcitabineDrug

    IV infusion

Study groups in NCT06619236
Study groupRoleWhat they receive
Rina-SExperimentalNot described
Receives: Drug: Rina-S
Investigator's ChoiceActive comparatorNot described
Receives: Drug: Paclitaxel; Drug: Topotecan; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 1.5 years

Secondary outcomes (10)

  1. Overall Survival (OS)

    OS is defined as the time from date of randomization to date of death due to any cause.

    Measured: Up to approximately 1.5 years

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.

    Measured: Up to approximately 1.5 years

  3. PFS as Determined by BICR

    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 RECIST version 1.1 as determined by BICR.

    Measured: Up to approximately 1.5 years

  4. ORR as Determined by BICR

    ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.

    Measured: Up to approximately 1.5 years

  5. Duration of Response (DOR)

    DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).

    Measured: Up to approximately 1.5 years

  6. Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria

    A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.

    Measured: Up to approximately 1.5 years

  7. Time to Second Disease Progression or Death From any Cause (PFS2)

    PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.

    Measured: Up to approximately 1.5 years

  8. Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)

    Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level.

    Measured: Baseline, up to approximately 1.5 years

  9. Time to Deterioration (TTD) in the GHS/Qol Score

    TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome.

    Measured: Up to approximately 1.5 years

  10. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start7 Feb 2025
  3. Primary completion18 Aug 2026
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
584 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619236
Sponsor's protocol ID
GCT1184-02
Other IDs
jRCT2031250064, CTR20253987, PRO1184-002, GOG-3107, ENGOT-OV86, 2024-514822-21
Acronym
RAINFOL-02
Status last verified
Sep 2026
First submitted
20 Sep 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rina-S, Paclitaxel and Topotecan in people with Platinum-resistant Ovarian Cancer, run by Genmab at 177 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Germany, Japan, Spain, Belgium and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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