AzTrials
AzTrials

Endometrial CancerPhase 3RAINFOL-03NCT07166094

Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

A Phase 3 study testing Rina-S and IC in people with Endometrial Cancer and Recurrent or Progressive Endometrial Cancer, run by Genmab at 178 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Rina-S and IC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
178 sitesin 19 countries
Study dates
28 Nov 2025to Nov 2029
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 recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
  • Participants must have received at least 1, but not more than 3, prior lines of therapy:
  • Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
  • If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.
  • Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
  • Prior induction plus maintenance is considered 1 line of therapy
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  • Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
  • Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
  • Participants must have progressed radiographically on or after their most recent line of therapy

Who cannot join

  • Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
  • Has a past or current malignancy other than the inclusion diagnosis before the planned 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 cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).
  • 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 completion of 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 planned 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 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.
  • Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Trial locations and contacts

178 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Genmab Trial Information contact

+4570202728

clinicaltrials@genmab.com

178 sites in 19 countries

United States69 sites, 69 recruiting

  • TX Onc - Arlington North

    Arlington, Texas, 76012

    Recruiting

  • Emory Winship Cancer Inst.

    Atlanta, Georgia, 30308

    Recruiting

  • Emory Winship Cancer Inst.

    Atlanta, Georgia, 30322

    Recruiting

  • Northside Hospital Atlanta

    Atlanta, Georgia, 30342

    Recruiting

  • USOR - Texas Oncology

    Austin, Texas, 78731

    Recruiting

  • USOR - Texas Oncology

    Austin, Texas, 78745

    Recruiting

  • USOR - Texas Oncology- Austin North

    Austin, Texas, 78758

    Recruiting

  • Sinai Hospital

    Baltimore, Maryland, 21215

    Recruiting

  • OLOL Cancer Institute

    Baton Rouge, Louisiana, 70808

    Recruiting

  • TX Onc - Bedford

    Bedford, Texas, 76022

    Recruiting

  • Atrium Health LCI - Morehead

    Charlotte, North Carolina, 28204

    Recruiting

  • Atrium Health LCI - Ballantyne

    Charlotte, North Carolina, 28277

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Recruiting

  • Atrium Health LCI - Concord

    Concord, North Carolina, 28025

    Recruiting

  • USOR - Minnesota Oncology-Coon Rapids Clinic

    Coon Rapids, Minnesota, 55433

    Recruiting

  • USOR - Minnesota Oncology/ Coon Rapids Clinic

    Coon Rapids, Minnesota, 55433

    Recruiting

  • TX Onc - Methodist Dallas

    Dallas, Texas, 75203

    Recruiting

  • TX Onc - Presbyterian Dallas

    Dallas, Texas, 75231

    Recruiting

  • TX Onc - Methodist Charlton

    Dallas, Texas, 75237

    Recruiting

  • TX Onc - Sammons

    Dallas, Texas, 75246

    Recruiting

  • Norwalk Hospital

    Danbury, Connecticut, 06810

    Recruiting

  • Emory Winship Cancer Inst./Emory Decatur Hospital

    Decatur, Georgia, 30033

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710

    Recruiting

  • USOR - Minnesota Oncology - Edina Clinic

    Edina, Minnesota, 55435

    Recruiting

  • USOR - Minnesota Oncology/Edina Clinic

    Edina, Minnesota, 55435

    Recruiting

  • Willamette Valley Cancer Institute and Research Center - Eugene

    Eugene, Oregon, 97401

    Recruiting

  • Endeavor Health NorthShore

    Evanston, Illinois, 60201

    Recruiting

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

    Fort Worth, Texas, 76104

    Recruiting

  • Atrium Health LCI - Gaston

    Gastonia, North Carolina, 28054

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Recruiting

  • NW Cancer Specs. P.C.

    Happy Valley, Oregon, 97015

    Recruiting

  • USOR - Texas Oncology

    Harlingen, Texas, 78550

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Recruiting

  • Kaiser Permanente SoCal

    Irvine, California, 92618

    Recruiting

  • USOR - Minnesota Oncology/ Maple Grove Clinic

    Maple Grove, Minnesota, 55369

    Recruiting

  • USOR - Minnesota Oncology-Maplewood Clinic

    Maplewood, Minnesota, 55109

    Recruiting

  • USOR - Minnesota Oncology/ Maplewood Clinic

    Maplewood, Minnesota, 55109

    Recruiting

  • USOR - Texas Oncology

    McAllen, Texas, 78503

    Recruiting

  • USOR - Minnesota Oncology/ Minneapolis Clinic

    Minneapolis, Minnesota, 55404

    Recruiting

  • USOR - Minnesota Oncology

    Minneapolis, Minnesota, 55404

    Recruiting

  • USAH Mitchell Cancer Inst

    Mobile, Alabama, 36604

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Recruiting

  • LSU Health New Orleans

    New Orleans, Louisiana, 70112

    Recruiting

  • NYU Laura and Isaac Perlmutter Cancer Center - 34th Street

    New York, New York, 10016

    Recruiting

  • Perlmutter CC NYU Langone LI

    New York, New York, 11501

    Recruiting

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

    Recruiting

  • HonorHealth Research Inst

    Phoenix, Arizona, 85016

    Recruiting

  • USOR - NW Cancer Specs P.C.

    Portland, Oregon, 97227

    Recruiting

  • USOR - TX Oncology - SA NE

    San Antonio, Texas, 78217

    Recruiting

  • NEXT San Antonio

    San Antonio, Texas, 78240

    Recruiting

  • CPMC Research Institute

    San Francisco, California, 94109

    Recruiting

  • SMH - Sarasota - Main Campus

    Sarasota, Florida, 34239

    Recruiting

  • Trials365, LLC

    Shreveport, Louisiana, 71103

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Women's Care - 9th Ave

    St. Petersburg, Florida, 33713

    Recruiting

  • Atlantic Health - Overlook MC

    Summit, New Jersey, 07901

    Recruiting

  • Women's Care - Armenia Ave

    Tampa, Florida, 33603

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

    Recruiting

  • USOR - NW Cancer Specs. P.C.

    Tigard, Oregon, 97223

    Recruiting

  • USOR - NW Cancer Specs P.C.

    Vancouver, Washington, 98684

    Recruiting

  • USOR - Texas Oncology- Horizon Circle

    Waco, Texas, 76712

    Recruiting

  • USOR - Texas Oncology- Waco

    Waco, Texas, 76712

    Recruiting

  • MedStar Washington Hospital

    Washington D.C., District of Columbia, 20010

    Recruiting

  • USOR - Texas Oncology

    Weslaco, Texas, 78596

    Recruiting

  • William Kahlert Reg. Can. Ctr

    Westminster, Maryland, 21157

    Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina, 27517

    Recruiting

  • USOR - Minnesota Oncology/ Woodbury Clinic

    Woodbury, Minnesota, 55125

    Recruiting

  • UMass Memorial Medical Ctr

    Worcester, Massachusetts, 01605

    Recruiting

Other trials in United States

Japan20 sites, 20 recruiting

  • Chiba University Hospital- Center for Outpatient

    Chiba, Chiba, 260-8677

    Recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577

    Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1347

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960-1247

    Recruiting

  • Hyogo Cancer Center

    Hyōgo, 673-0021

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka, 411-8777

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata

    Recruiting

  • Osaka International Cancer Institute - Osaka - Otemae Acti

    Osaka, Osaka, 541-8567

    Recruiting

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550

    Recruiting

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0373

    Recruiting

  • Saitama Medical University - International Medical Center

    Saitama, 350-1298

    Recruiting

  • Sapporo Medical University Hospital

    Sapporo, 060-8543

    Recruiting

  • NUC Tohoku Univ. Hospital

    Sendai, Miyagi, 980-8574

    Recruiting

  • Iwate Medical University Hosp

    Shiwa-gun, Iwate, 028-3695

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686

    Recruiting

  • Keio University Hospital

    Tokyo, Tokyo, 160-8582

    Recruiting

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

    Recruiting

  • Mie University Hospital

    Tsu, Kansai, 514-8507

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

    Recruiting

Other trials in Japan

Spain16 sites, 16 recruiting

  • CHU A Coruña

    A Coruña, La Coruña, 15006

    Recruiting

  • Vall d'Hebron

    Barcelona, Catalonia, 08035

    Recruiting

  • Hospital Clínic BCN

    Barcelona, Catalonia, 08036

    Recruiting

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, GI, 17007

    Recruiting

  • CUN Madrid

    Madrid, Madrid, 28027

    Recruiting

  • Hospital 12 de Octubre

    Madrid, Madrid, 28041

    Recruiting

  • HM Sanchinarro

    Madrid, Madrid, 28050

    Recruiting

  • Hospital La Paz

    Madrid, 28046

    Recruiting

  • HU Virgen de la Victoria

    Málaga, Málaga, 29010

    Recruiting

  • H.R.U. Málaga - Materno-Inf.

    Málaga, 7120

    Recruiting

  • Hosp. Univ. Son Espases

    Palma de Mallorca, Balearic Islands, 07120

    Recruiting

  • CUN Pamplona

    Pamplona, Navarre, 31008

    Recruiting

  • HU Virgen del Rocío

    Seville, 41013

    Recruiting

  • HU Virgen de Valme

    Seville, 41014

    Recruiting

  • IVO Valencia

    Valencia, Valenciana, Comunidad, 46009

    Recruiting

  • HU Miguel Servet

    Zaragoza, Zaragoza, 50009

    Recruiting

Other trials in Spain

France13 sites, 13 recruiting

  • ICO Angers

    Angers, Pays de la Loire Region, 49055

    Recruiting

  • CH de la Côte Basque

    Bayonne, Pyrénées-Atlantiques, 64109

    Recruiting

  • Clinique Tivoli Ducos

    Bordeaux, Gironde, 33000

    Recruiting

  • CHU Brest - Cavale Blanche

    Brest, Brittany Region, 29609

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63011

    Recruiting

  • CGFL Dijon

    Dijon, Bourgogne-Franche-Comté, 21079

    Recruiting

  • GHM Grenoble

    Grenoble, Auvergne-Rhône-Alpes, 38028

    Recruiting

  • ICM Montpellier

    Montpellier, Occitanie, 34298

    Recruiting

  • L'Hôpital Privé Nancy Lorraine

    Nancy, Meurthe-Et-Moselle, 54000

    Recruiting

  • CHU Orléans - Pharmacie

    Orléans, Loiret, 45067

    Recruiting

  • Cancer Institute Jean Godinot

    Reims, Marne, 51092

    Recruiting

  • HUS Strasbourg

    Strasbourg, Bas-Rhin, 67200

    Recruiting

  • Hôpital Foch

    Suresnes, Île-de-France Region, 92150

    Recruiting

Other trials in France

Italy8 sites, 8 recruiting

  • AOU Sant Orsola Malpighi

    Bologna, BO, 40138

    Recruiting

  • Cannizzaro Hospital Authority

    Catania, CA, 95126

    Recruiting

  • Irst Meldola

    Meldola, FC, 47014

    Recruiting

  • European Institute of Oncology

    Milan, MI, 20141

    Recruiting

  • Humanitas San Pio X

    Milan, MI, 20159

    Recruiting

  • IRCCS San Gerardo Tintori

    Monza, MB, 20900

    Recruiting

  • Ospedale S Stefano

    Prato, PO, 59100

    Recruiting

  • AUSL IRCCS Reggio Emilia

    Reggio Emilia, RE, 42123

    Recruiting

Other trials in Italy

Australia7 sites, 7 recruiting

  • GenesisCare Campbelltown

    Campbelltown, New South Wales, 2560

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • Gosford Hospital

    Gosford, New South Wales, 02250

    Recruiting

  • Austin Health

    Heidelberg, Heidelberg, 3084

    Recruiting

  • Joondalup Health Campus

    Joondalup, Western Australia, 6027

    Recruiting

  • Nepean Cancer & Wellness Ctr

    Kingswood, New South Wales, 2747

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Recruiting

Other trials in Australia

Belgium6 sites, 6 recruiting

  • Saint-Luc University Clinics

    Brussels, Brussels Capital, 1200

    Recruiting

  • Antwerp University Hospital

    Edegem, Antwerp, 2650

    Recruiting

  • Grand Hôpital de Charleroi

    Gilly, Hainaut, 6060

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, Flanders, 3000

    Recruiting

  • CHU UCL Namur/Ste Elisabeth

    Namur, Wallonia, 5000

    Recruiting

  • VITAZ

    Sint-Niklaas, Sint-Niklaas, 9100

    Recruiting

Other trials in Belgium

Israel6 sites, 6 recruiting

  • Assuta Ashdod Hospital

    Ashdod, Southern Israel, 7747629

    Recruiting

  • Rambam Medical Center

    Haifa, Haifa District, 3109601

    Recruiting

  • CARMEL

    Haifa, Haifa District, 3436212

    Recruiting

  • Wolfson Medical Center

    Holon, Holon, 58110

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102

    Recruiting

  • Galilee Medical Center

    Nahariya, Nahariya, 2210001

    Recruiting

Other trials in Israel

Poland6 sites, 6 recruiting

  • Białystok Onc. Ctr. (MSC), GO

    Bialystok, Podlaskie Voivodeship, 15-027

    Recruiting

  • ŚCO SPZOZ Kielce

    Kielce, 25-734

    Recruiting

  • ICZMP

    Lodz, Łódź Voivodeship, 93-338

    Recruiting

  • Centrum Onkologi Ziemi Lubelsk

    Lublin, Lublin Voivodeship, 20-090

    Recruiting

  • Siedleckie Centrum Onkologii

    Siedlce, Masovian Voivodeship, 08-110

    Recruiting

  • UCH No. 2, PMU Szczecin

    Szczecin, West Pomeranian Voivodeship, 70-111

    Recruiting

Other trials in Poland

Germany5 sites, 5 recruiting

  • Helios Hospital Berlin-Buch

    Berlin, State of Berlin, 13125

    Recruiting

  • Bonn University Hospital

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

  • Asklepios Hospital Barmbek

    Hamburg, Free and Hanseatic City of Hamburg, 22453

    Recruiting

  • Klinikum Lippe GmbH Pharmacy

    Lemgo, North Rhine-Westphalia, 32657

    Recruiting

  • Central Whse (Zentrallager)

    Wiesbaden, Hesse (Hessen), 65199

    Recruiting

Other trials in Germany

Brazil4 sites, 4 recruiting

  • Futtura Oncologia - Hub Pesq

    Porto Alegre, Rio Grande do Sul, 90470-340

    Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

    Recruiting

  • Oncoclinicas RJ S.A.

    Rio de Janeiro, Rio de Janeiro, 2250-905

    Recruiting

  • Hospital Nove de Julho

    São Paulo, São Paulo, 01308-070

    Recruiting

Other trials in Brazil

Finland4 sites, 4 recruiting

  • Hus Ccc/Ctu

    Helsinki, Helsinki, 00250

    Recruiting

  • Kuopio Univ. Hospital, PSHVA

    Kuopio, Northern Savonia, 70210

    Recruiting

  • Oulu University Hospital

    Oulu, North Ostrobothnia, 90220

    Recruiting

  • Tampere University Hospital

    Tampere, Pirkanmaa, 33520

    Recruiting

Other trials in Finland

Canada3 sites, 3 recruiting

  • Arthur J E Child Cancer Comp

    Calgary, Alberta, T2N 5G2

    Recruiting

  • MUHC - Glen Site

    Montreal, Quebec, H4A 3J1

    Recruiting

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Recruiting

Other trials in Canada

Greece3 sites, 3 recruiting

  • Aretaieio Hospital

    Athens, 115 28

    Recruiting

  • Alexandra General Hospital

    Athens, 11528

    Recruiting

  • UGH Patras

    Pátrai, RIO, 265 04

    Recruiting

Other trials in Greece

Lithuania2 sites, 2 recruiting

  • LSMU Hospital Kauno klinikos

    Kaunas, Central Lithuania, LT-45434

    Recruiting

  • Dept., VUH Santaros Clinics

    Vilnius, Vilnius County, LT-08406

    Recruiting

Other trials in Lithuania

Norway2 sites, 2 recruiting

  • Haukeland University Hospital

    Bergen, Vestland, NO-5021

    Recruiting

  • OUH Radium Hospital

    Oslo, Oslofjord, 0379

    Recruiting

Other trials in Norway

Singapore2 sites, 2 recruiting

  • NUH Singapore

    Singapore, Singapore, 119082

    Recruiting

  • Curie Oncology (Farrer)

    Singapore, Singapore, 217562

    Recruiting

Other trials in Singapore

Denmark1 site, 1 recruiting

  • Aalborg University Hospital

    Aalborg, 9000

    Recruiting

Other trials in Denmark

Puerto Rico1 site, 1 recruiting

  • PR Cancer Specialists

    San Juan, 00917

    Recruiting

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 Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.

The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected.

All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).

Read the detailed description

This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy.

Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.

Being tested
Rina-S, IC
Medical subject headings
Endometrial Neoplasms, Recurrence

What participants receive

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

  • Rina-SDrug

    Also called Rinatabart Sesutecan, PRO1184, GEN1184

    Intravenous (IV) infusion.

  • ICDrug

    • Paclitaxel: IV infusion
    • Doxorubicin: IV bolus injection/infusion
Study groups in NCT07166094
Study groupRoleWhat they receive
Rina-SExperimentalParticipants will receive Rina-S on Day 1 once every 3 weeks (Q3W).
Receives: Drug: Rina-S
ICActive comparatorParticipants will receive one of the following chemotherapies at the discretion of the investigator: * Paclitaxel on Days 1, 8, and 15 every 4 weeks (Q4W). * Doxorubicin on Day 1 Q3W.
Receives: Drug: IC

What is being measured

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

  1. Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)

    Measured: Up to approximately 3 years

  2. Overall Survival (OS)

    Measured: Up to approximately 3 years

Secondary outcomes (8)

  1. Objective Response Rate (ORR), per RECIST v1.1, as Determined by BICR

    Measured: Up to approximately 3 years

  2. PFS, per RECIST v1.1, as Determined by Investigator Assessment

    Measured: Up to approximately 3 years

  3. ORR, per RECIST v1.1, as Determined by Investigator Assessment

    Measured: Up to approximately 3 years

  4. Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment

    Measured: Up to approximately 3 years

  5. DOR, per RECIST v1.1, as Determined by BICR

    Measured: Up to approximately 3 years

  6. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 3 years

  7. Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)

    Measured: Baseline up to approximately 3 years

  8. Time to Deterioration (TTD) in GHS/Qol

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted10 Sep 2025
  2. Study start28 Nov 2025
  3. Primary completionAug 2029 (estimated)
  4. Study completionNov 2029 (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
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166094
Sponsor's protocol ID
GCT1184-03
Other IDs
jRCT2031250494, MOH_2026-03-29_015739, 2024-519818-31, GOG-3128, ENGOT-en31, GEICO-158-E
Acronym
RAINFOL-03
Status last verified
Oct 2026
First submitted
9 Sep 2025
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 and IC in people with Endometrial Cancer and Recurrent or Progressive Endometrial Cancer, run by Genmab at 178 sites in 19 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 9 inclusion and 5 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: looking for participants now, 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 178 sites in United States, Japan, Spain, France, Italy and 14 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?

Contact Genmab Trial Information (+4570202728, clinicaltrials@genmab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. 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 NCT07166094.

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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