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Endometrial CancerPhase 3XPORT-EC-042NCT05611931

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

A Phase 3 study testing Selinexor in people with Endometrial Cancer, run by Karyopharm Therapeutics Inc at 185 sites in 17 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

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endometrial Cancer
What is being tested?
Selinexor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
257 participants
Where
185 sitesin 17 countries
Study dates
18 Apr 2023to Jan 2028
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Patients must meet all of the following inclusion criteria in order to be eligible to participate in this study:

  • Adults (Aged ≥ 18 years)
  • Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated, or carcinosarcoma sub-types) that is TP53 wild type by central NGS
  • Must have completed at least 12 weeks of platinum-based chemotherapy (with or without immune checkpoint inhibitors), with a confirmed partial or complete response according to RECIST v1.1
  • Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow function and organ function

Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible to participate in this study:

  • Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine differentiation
  • Palliative radiotherapy administered within 14 days of intended C1D1
  • Any gastrointestinal dysfunction that could interfere with the absorption of oral study therapy
  • Serious psychiatric or medical conditions that could interfere with study participation or would make study involvement unreasonably hazardous
  • Previous treatment with an XPO1 inhibitor
  • Stable disease or disease progression after platinum-based chemotherapy
  • Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
  • Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune checkpoint inhibitor

Trial locations and contacts

185 sites in 17 countries.

185 sites in 17 countries

United States65 sites

  • Women's Cancer Care Associates, LLC

    Albany, New York, 12208

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Grady Hospital

    Atlanta, Georgia, 30303

  • Emory University

    Atlanta, Georgia, 30322

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • USON - Texas Oncology, Austin Central

    Austin, Texas, 78731

  • Intermountain Health St. Vincent Regional Hospital

    Billings, Montana, 59101

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina, 28209

  • University of Virginia

    Charlottesville, Virginia, 22908

  • MetroHealth

    Cleveland, Ohio, 44109

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • Parkland Health & Hospital System

    Dallas, Texas, 75235

  • Texas Oncology - Dallas

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • UC DAVIS

    Davis, California, 95616

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • Northwest Cancer Center

    Dyer, Indiana, 46311

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Goshen Health

    Goshen, Indiana, 46526

  • Houston Methodist

    Houston, Texas, 77030

  • St Vincent Hospital

    Indianapolis, Indiana, 46260

  • University of Iowa

    Iowa City, Iowa, 52242

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • St. Dominic's Gynecologic Oncology

    Jackson, Mississippi, 39216

  • Midwest Ventures Group HCA MId America Division

    Kansas City, Missouri, 64132

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Alliance Cancer Specialists

    Langhorne, Pennsylvania, 19047

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • UCLA - Women's Health Clinical Research Unit

    Los Angeles, California, 90095

  • Long Beach Memorial Medical Center

    Los Angeles, California, 90806

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38103

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • NYU Langone Hospital-Long Island

    Mineola, New York, 11501

  • USON - Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Northwell Health - Zuckerberg Cancer Center

    New Hyde Park, New York, 11042

  • LSU Health Sciences Center New Orleans

    New Orleans, Louisiana, 70119

  • Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Lenox Hill Hospital

    New York, New York, 10075

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Advent Health

    Orlando, Florida, 32804

  • Stanford University

    Palo Alto, California, 94304

  • Honor Health

    Phoenix, Arizona, 85016

  • Magee - Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Allegheny Health Network - West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Northwell Health - Queens Cancer Center

    Rego Park, New York, 11374

  • Center Of Hope

    Reno, Nevada, 89511

  • University of Rochester

    Rochester, New York, 14642

  • University of Utah

    Salt Lake City, Utah, 84112

  • Texas Oncology - San Antonio

    San Antonio, Texas, 78240

  • California Pacific Medical Center

    San Francisco, California, 94109

  • Avera

    Sioux Falls, South Dakota, 57105

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • Texas Oncology, PC, Tyler

    Tyler, Texas, 75702

Other trials in United States

Spain21 sites

  • ICO Badalona

    Badalona, 08916

  • Hospital Universitari Vall d' Hebrón

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Institut Catala d'Oncologia Hospitalet

    Barcelona, 08908

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Institut Catala d'Oncologia de Girona

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • H 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitatrio Virgen de la Victoria

    Málaga, 29010

  • Virgen de la Arrixaca University Clinical Hospital

    Murcia, 30120

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital LaFe Uacenlia

    Valencia, 46026

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Australia15 sites

  • Border Medical Oncology & Haematology

    Albury, New South Wales, 2640

  • Box Hill Hospital - Eastern Health (Oncology)

    Box Hill, Victoria, 3128

  • Macarthur Cancer Therapy Centre

    Campbelltown, New South Wales, 2560

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Monash Health

    Clayton, Victoria, 3168

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Central Coast LHD - Gosford & Wyong Hospitals

    Gosford, New South Wales, 2250

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Cabrini Health

    Malvern, Victoria, 3144

  • Newcastle Private Hospital

    New Lambton Heights, New South Wales, 2305

  • Royal North Shore Hospital

    Saint Leonards, New South Wales

  • ICON Cancer Centre Southport

    Southport, Queensland, 4215

  • The Royal Adelaide Hospital

    Southport, 5000

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

Other trials in Australia

Italy15 sites

  • IRCCS Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138

  • ASST Spedali Civili Di Brescia

    Brescia, 25123

  • IRCCS Istituto Romagnolo Per Lo Studio Del Tumori "Dino Amadori" - IRST S.R.L.

    Meldola, 47014

  • San Raffaele Hospital

    Milan, 20132

  • Istituto Nazionale dei Tumori IRCCS - MILANO S. C. Ginecologia Oncologica

    Milan, 20133

  • Instituto Europeo di Oncologia

    Milan, 20141

  • Humanitas San Pio X Hospital

    Milan, 20159

  • Ospedale San Gerardo - Asst Monza

    Monza, 20900

  • "Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica"

    Naples, 20133

  • Istituto Oncologico Veneto

    Padova, 35128

  • Universita di Pisa

    Pisa, 56127

  • Nuovo Ospedale di Prato

    Prato, 59100

  • Fondazione Policlinico Universitario Agostino Gemelli - ROMA

    Roma, 00168

  • Ospedale Ostetrico Ginecologico Sant'Anna

    Torino, 10124

  • AO Ordine Mauriziano

    Torino, 10128

Other trials in Italy

Germany11 sites

  • Charite Berlin Universitatsmedizin

    Berlin, 13353

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • University Hospital Dresden

    Kiel, 01307

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • Helios Klinikum Krefeld

    Krefeld, 47805

  • Universitätsklinik Leipzig

    Leipzig, 04103

  • Universitätsfrauenklinik Mainz

    Mainz, 55131

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe GroBhadern

    Munich, 80337

  • Klinikum Südstadt Rostock

    Rostock, 18059

  • Universitätsfrauenklinik Ulm

    Ulm, 89075

Other trials in Germany

Georgia8 sites

  • High Technology Hospital Medcenter

    Batumi, 6000

  • Todua Clinic

    Tbilisi, 0112

  • LTD New Hospitals

    Tbilisi, 0114

  • Tbilisi Cancer Center

    Tbilisi, 0156

  • JSC - K.Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 0159

  • Caucasus Medical Centre

    Tbilisi, 0186

  • LTD Innova Medical Center

    Tbilisi, 0186

  • Multiprofile Clinic "Consilium Medulla"

    Tbilisi, 0186

Other trials in Georgia

Turkey (Türkiye)7 sites

  • Çukurova University

    Adana, 01330

  • Adana Baskent Hospital

    Adana, 34920

  • Hacettepe University Oncology Hospital

    Ankara, 06230

  • Memorial Ankara Hospital

    Ankara, 06520

  • Ankara Baskent Hospital

    Çankaya, Ankara, 34093

  • Cerrahpasa University

    Istanbul, 34098

  • Acibadem Atakent Hospital

    Istanbul, 34303

Other trials in Turkey (Türkiye)

Canada6 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0C1

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A3J1

  • Hospital Maisonneuve-Rosemont

    Montreal, Quebec

  • Princess Margaret

    Toronto, Ontario, M5G 2M9

  • Sunnybrook Research Institute

    Toronto, Ontario, M9L 2H9

Other trials in Canada

Taiwan6 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833401

  • TaiChung Veterans General Hospital

    Taichung, 407219

  • Chi Mei Medical Center

    Tainan, 71004

  • Mackay Memorial Hospital

    Taipei, 104217

  • Taipei Medical University- Shuang Ho Hospital, Ministry of Health and Welfare

    Taipei, 23561

  • Chang Gung Memorial Hospital

    Taoyuan City, 333

Other trials in Taiwan

Belgium5 sites

  • Cliniques Universitaires St. Luc

    Brussels, 1200

  • AZ Sint Lucas

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHU Ambroise Pare

    Mons, 7000

  • CHU UCL Namur, Site Sainte-Elisabeth

    Namur, 5000

Other trials in Belgium

Czechia5 sites

  • University Hospital Brno

    Brno, 60200

  • University Hospital Ostrava

    Ostrava, 70852

  • UH Královské Vinohrady

    Prague, 10034

  • General University Hospital in Prague

    Prague, 12851

  • Hospital Na Bulovce

    Prague, 18100

Other trials in Czechia

Ireland5 sites

  • Cork University Hospital

    Cork, T12 DC4A

  • St. Vincent's University Hospital

    Dublin, Elm Park, D04 T6F4

  • St. James Hospital

    Dublin, D08 NHY1

  • Galway University

    Galway, H91 YR71

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Israel4 sites

  • Hillel-Yaffe Medical Center

    Hadera, 38100

  • Wolfson Medical Center

    Holon

  • Hadassah Medical Center

    Jerusalem, 91120

  • Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

Slovakia4 sites

  • St. Elisabeth Cancer Institute

    Bratislava, 81250

  • UH Bratislava

    Bratislava, 82606

  • National Cancer Institute

    Bratislava, 83310

  • UH Trenčín

    Trenčín, 91101

Other trials in Slovakia

Greece3 sites

  • Alexandra Hospital

    Athens, 11528

  • Hygeia Hospital

    Athens, 15123

  • Euromedica General Clinic

    Thessaloniki, 54645

Other trials in Greece

South Korea3 sites

  • CHA University/Bundang CHA General Hospital

    Seongnam-si, 59

  • Seoul National University Hospital

    Seoul, 03080

  • Korea University Anam Hospital

    Seoul, 73

Other trials in South Korea

Hungary2 sites

  • Unit of Gynecol.Oncol., Dept.Obstet.Gynecol., Clinical Center, University of Debrecen

    Debrecen, 4032

  • Petz Aladár University Teaching Hospital

    Győr, 9024

Other trials in Hungary

About this study

Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 276 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

Being tested
Selinexor, Matching Placebo for selinexor
Keywords
Selinexor, KPT-330, Advanced or Recurrent Endometrial Carcinoma, XPORT-EC, ENGOT-EN20, GOG-3083, XPORT-EC-042, p53 wild-type, Tumor protein 53 wild-type
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • SelinexorDrug

    Also called KPT-330

    Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

  • Matching Placebo for selinexorDrug

    Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Study groups in NCT05611931
Study groupRoleWhat they receive
SelinexorExperimentalParticipants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.
Receives: Drug: Selinexor
PlaceboPlacebo comparatorParticipants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Receives: Drug: Matching Placebo for selinexor

What is being measured

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

  1. Investigator assessed Progression Free Survival (PFS) per RECIST v1.1

    Measured: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)

Secondary outcomes (7)

  1. Overall Survival (OS)

    Time from randomization to death due to any cause

    Measured: Up to 34 months

  2. Safety and tolerability of study drug (selinexor and placebo)

    The safety and tolerability of study drug (selinexor and placebo) will be evaluated based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results, by means of the occurrence, nature, and severity of AEs via Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.

    Measured: From start of study drug administration up to 34 months

  3. Time to First Subsequent Therapy (TFST)

    Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first

    Measured: From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)

  4. Time to Second Subsequent Therapy (TSST)

    Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first

    Measured: From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)

  5. Progression-free survival after initiating a next-line treatment (PFS2)

    Time from randomization until the progression event after initiating a next-line treatment or death due to any cause, whichever occurs first

    Measured: From randomization until the next-line progression event or death due to any cause, up to 34 months

  6. Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1

    Measured: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)

  7. EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L)

    EQ-5D-5L is a generic questionnaire that assesses health status as perceived by the patient across 5 categories (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and overall.

    Measured: From baseline and at specified timepoints up to 34 months

Timeline

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

  1. First posted10 Nov 2022
  2. Study start18 Apr 2023
  3. Primary completion22 May 2026
  4. Study completionJan 2028 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05611931
Sponsor's protocol ID
XPORT-EC-042
Other IDs
GOG-3083, ENGOT-EN20
Acronym
XPORT-EC-042
Status last verified
Oct 2026
First submitted
3 Nov 2022
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.

    PubMed 40966692

  • Makker V, Perez-Fidalgo JA, Valabrega G, Hamilton E, Van Gorp T, Sehouli J, Reginacova K, Richardson DL, Perri T, Oza AM, Miller DS, Alia EMG, De Giorgi U, Henry S, Spitz DL, Wimberger P, Bednarikova M, Chon HS, Martinez-Garcia J, Pisano C, Berek JS, Romero I, Scambia G, Farinas-Madrid L, Buscema J, Schochter F, Li K, Kalyanapu P, Walker CJ, Vergote I. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study. Gynecol Oncol. 2024 Jun;185:202-211. doi: 10.1016/j.ygyno.2024.05.016. Epub 2024 Jun 3.

    PubMed 38834399

  • Vergote I, Perez Fidalgo A, Valabrega G, Monk BJ, Herzog T, Cibula D, Colombo N, Pothuri B, Sehouli J, Korach J, Barlin J, Papadimitriou CA, van Gorp T, Richardson D, McCarthy M, Antill Y, Mirza MR, Li K, Kalyanapu P, Slomovitz B, Coleman RL. ENGOT-EN20/GOG-3083/XPORT-EC-042 - A phase III, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced, or recurrent endometrial carcinoma: rationale, methods, and trial design. Int J Gynecol Cancer. 2024 Aug 5;34(8):1283-1289. doi: 10.1136/ijgc-2024-005412.

    PubMed 38627035

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selinexor in people with Endometrial Cancer, run by Karyopharm Therapeutics Inc at 185 sites in 17 countries.

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

Who may be eligible to take part?

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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in United States, Spain, Australia, Italy, Germany and 12 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. Some participants in this study may receive a placebo. 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?

Investigator assessed Progression Free Survival (PFS) per RECIST v1.1 (time frame: From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)). 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 NCT05611931, which also lists 3 linked publications.

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 29 Oct 2026.

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