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Multiple MyelomaPhase 3iMMagine-3NCT06413498

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

A Phase 3 study testing Anitocabtagene Autoleucel, Cyclophosphamide and Fludarabine in people with Multiple Myeloma, run by Kite, A Gilead Company at 117 sites in 15 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 goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Anitocabtagene Autoleucel, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
117 sitesin 15 countries
Study dates
23 Aug 2024to Jul 2031
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

Who may be able to join

  • Documented historical diagnosis of multiple myeloma (MM)
  • Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
  • Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
  • Measurable disease at screening per IMWG, defined as any of the following:
  • Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
  • Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio
Show all 9Show fewer
  • Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

Who cannot join

  • Prior B-cell maturation antigen (BCMA)-targeted therapy
  • Prior T-cell engager therapy
  • Prior CAR therapy or other genetically modified T-cell therapy
  • Active or prior history of central nervous system (CNS) or meningeal involvement of MM
  • Cardiac atrial or cardiac ventricular MM involvement
  • History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
Show all 15Show fewer
  • Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
  • Prior auto-SCT within 12 weeks before randomization
  • Prior allogeneic stem cell transplant (allo-SCT)
  • High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
  • Live vaccine ≤ 4 weeks before randomization
  • Contraindication to fludarabine or cyclophosphamide
  • History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
  • Life expectancy < 12 weeks
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

117 sites in 15 countries.

117 sites in 15 countries

United States46 sites

  • New Mexico Cancer Research Alliance

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • St. David's South Austin Medical Center

    Austin, Texas, 78704

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • St. Luke's Cancer Institute

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219

  • Sylvester Comprehensive Cancer Center

    Coral Gables, Florida, 33146

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Mayo Clinic Hospital

    Gilbert, Arizona, 85234

  • Corewell Health - Lemmen-Holton Cancer Pavilion

    Grand Rapids, Michigan, 49503

  • Houston Methodist Hospital Cancer Center

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • IU Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Jacksonville, Florida, 32256

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207

  • Baptist Cancer Center

    Memphis, Tennessee, 38104

  • Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research

    Nashville, Tennessee, 37203

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • Ochsner Clinical Foundation

    New Orleans, Louisiana, 70121

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Weill Cornell Medicine - New York Presbyterian Hosptial

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta

    Newnan, Georgia, 30265

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy

    Omaha, Nebraska, 68130

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • UC San Diego Moores Cancer Center

    San Diego, California, 92037

  • UCLA Hematology/Oncology (Bowyer Infusion Clinic)

    Santa Monica, California, 90404

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Stanford Cancer Institute

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Novant Health Cancer Institute Hematology- Forsyth

    Winston-Salem, North Carolina, 27103

Other trials in United States

Spain11 sites

  • ICO Badalona-H.U. Germans Trias i Pujol

    Badalona, 08916

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

France10 sites

  • CHU de Lille- Hopital Claude Huriez

    Lille, 59037

  • Institut Paoli Calmettes

    Marseille, 13273

  • CHU De Montpellier - Hopital Saint Eloi

    Montpellier, 34080

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75571

  • Hôpital Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • CHU de Rennes

    Rennes, 59037

  • CHU de Toulouse. IUCT Oncopole

    Toulouse, 31100

Other trials in France

Germany8 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203

  • Universitatsklinikum Koln, Klinik I fOr lnnere Medizin

    Cologne

  • Universitätsklinikum Essen

    Essen

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Universitatsklinikum Leipzig

    Leipzig, 4103

  • TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie

    München, 80333

  • Universitatsklinikum Wurzburg

    Tübingen, 72076

Other trials in Germany

Japan6 sites

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • The University of Osaka Hospital

    Osaka, 565-0871

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • Juntendo University School of Medicine Juntendo Clinic

    Tokyo, 113-8431

  • Japanese Red Cross Medical Center

    Tokyo, 150-8935

Other trials in Japan

United Kingdom6 sites

  • University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Leeds Teaching Hospitals NHS Trust, St James's University Hospital

    Leeds, LS9 7TF

  • King's College Hospital

    London, SE5 9NU

  • University College London Hospital

    London, WC1E 6JN

  • Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

    Newcastle, NE7 7DN

Other trials in United Kingdom

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, NSW 2050

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Epworth HealthCare

    Richmond, Victoria, 3121

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Italy5 sites

  • IRCCS AOU di Bologna

    Bologna, 40138

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133

  • Ospedale San Raffaele

    Milan, 3302

  • Policlinico Universitario Argostino Gemelli

    Roma, 00168

  • AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette

    Torino, 10126

Other trials in Italy

Austria4 sites

  • Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie

    Linz

  • Paracelsus Medizinischen Privatuniversitaet

    Salzburg, A-5020

  • University Hospital St. Poelten, Department of Internal Medicine I

    Sankt Pölten, 3100

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • University Hospital of Antwerp

    Edegem

  • UZ Leuven

    Flemish Brabant, 3000

  • UZ Gent

    Gent Oost-Vlaanderen, 9000

Other trials in Belgium

Canada4 sites

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9

  • McGill University Health Center

    Montreal, H4A 3J1

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • University Health Network - The Princess Margaret Cancer Centre

    Toronto, M5G 2M9

Other trials in Canada

Netherlands3 sites

  • Amsterdam UMC - Location vUmc

    Amsterdam, 1081 HV

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Erasmus Medical Center

    Rotterdam, 3015GD

Other trials in Netherlands

Poland3 sites

  • Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, 02-097

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, 50-367

Other trials in Poland

Czechia1 site

  • Fakultni Nemocnice Ostrava

    Severomoravsky KRAJ, 708 52

Other trials in Czechia

Switzerland1 site

  • Inselspital - Universitätsspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug.

The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Read the detailed description

After completing the treatment period, all participants who will receive anitocabtagene autoleucel, will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.

Being tested
Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Keywords
Multiple Myeloma, CAR-T, ddBCMA, BCMA
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Anitocabtagene AutoleucelDrug

    Also called CART-ddBCMA

    A single infusion of CAR+ transduced autologous T cells

  • CyclophosphamideDrug

    Administered intravenously

  • FludarabineDrug

    Administered intravenously

  • PomalidomideDrug

    Tablet administered orally

  • BortezomibDrug

    Administered intravenously or subcutaneously

  • DexamethasoneDrug

    Tablet administered orally

  • DaratumumabDrug

    Administered intravenously or subcutaneously

  • CarfilzomibDrug

    Administered intravenously

Study groups in NCT06413498
Study groupRoleWhat they receive
Anitocabtagene AutoleucelExperimentalParticipants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1.
Receives: Drug: Anitocabtagene Autoleucel; Drug: Cyclophosphamide; Drug: Fludarabine
Standard of Care Therapy (SOCT)Active comparatorParticipants will receive the investigator's choice of one of the following therapies: * pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles) * daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles) * carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles) * carfilzomib and dexamethasone (Kd) (28-day cycles)
Receives: Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Daratumumab; Drug: Carfilzomib

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 randomization to disease progression per International Myeloma Working Group (IMWG) criteria as determined by independent review committee (IRC), or death due to any cause, whichever occurs first.

    Measured: Up to 4 years

  2. Minimal Residual Disease (MRD) Complete Response (CR) Rate at 9 Months

    Minimal MRD is defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (< 1 in 105 nucleated cells per IMWG criteria using NGS) (Kumar 2016). CR/sCR per IMWG criteria is determined by IRC.

    Measured: Up to 9 months

Secondary outcomes (17)

  1. CR Rate (CR/ Stringent Complete Response (sCR))

    CR rate is defined as the proportion of participants who achieved a best overall response of CR or sCR per IMWG criteria as determined by IRC.

    Measured: Up to 4 years

  2. Overall MRD Negativity

    Overall MRD negativity, defined as the proportion of any MRD negativity in participants with bone marrow aspirate (< 1 in 10^5 nucleated cells per IMWG criteria using next-generation sequencing (NGS)) at any time after randomization until disease progression, subsequent anti-multiple myeloma (MM) therapy, or death.

    Measured: Up to 7 years

  3. Overall survival (OS)

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

    Measured: Up to 7 years

  4. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants who achieve a best overall response of at least partial response (PR) or better (sCR, CR, very good partial response (VGPR), or PR) per IMWG criteria.

    Measured: Up to 7 years

  5. MRD-negative CR/sCR

    MRD-negative CR/sCR is defined as the proportion of participants achieving MRD-negative CR/sCR until disease progression, subsequent anti-MM therapy, or death.

    Measured: Up to 7 years

  6. MRD-negative VGPR+

    MRD-negative VGPR+ is defined as the proportion of participants achieving MRD negativity and sCR/CR/VGPR until disease progression, subsequent anti-MM therapy, or death.

    Measured: Up to 7 years

  7. Sustained MRD Negativity

    Sustained MRD negativity is defined as the proportion of participants remaining MRD-negative at the 10^-5 sensitivity threshold for the specified number of months starting from the first MRD-negative assessment date to the last MRD-negative assessment date prior to disease progression, subsequent anti-MM therapy, or death. Duration may include ≥ 12 months. Sustained MRD negativity will be evaluated for overall MRD negativity, MRD-negative CR/sCR, and MRD-negative VGPR+.

    Measured: Up to 7 years

  8. Duration of Response (DOR)

    DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per IMWG criteria and is defined as the time from first overall response to disease progression per IMWG criteria, or death from any cause, whichever occurs first.

    Measured: Up to 7 years

  9. Time to Progression

    Time to progression is defined as the time from randomization to the first documented disease progression per IMWG criteria, or death due to disease progression, whichever occurs first.

    Measured: Up to 7 years

  10. Time to Next Treatment

    Time to next treatment is defined as the time from randomization to the start of subsequent anti-MM therapy or death from any cause, whichever occurs first.

    Measured: Up to 7 years

  11. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: First dose up to 7 years

  12. Percentage of Participants With Anti-Anitocabtagene Autoleucel CAR Antibodies (Anitocabtagene Autoleucel Arm)

    Measured: Up to 7 years

  13. Percentage of Participants With Presence of Replication-Competent Lentivirus (Anitocabtagene Autoleucel Arm)

    Measured: Up to 7 years

  14. Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

    The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) single item symptoms scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL). Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a high level of symptoms.

    Measured: Up to 7 years

  15. Change From Baseline in the EORTC - Multiple Myeloma Module (EORTC QLQ-MY20) Score

    The EORTC QLQ-MY20 has 20 items across 4 independent subscales; 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of one week. Scores from each subscale are transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening.

    Measured: Up to 7 years

  16. Change From Baseline in the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Score

    The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). The total score for EQ-5D-5L index is presented on a range where higher scores indicate better outcome. A positive change from Baseline indicates improvement.

    Measured: Up to 7 years

  17. Percentage of Participants Using Healthcare Resources

    Healthcare resource utilization will be assessed based on the numbers of hospitalizations, intensive care unit (ICU) inpatient days, and non-ICU inpatient days.

    Measured: Up to 7 years

Timeline

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

  1. First posted14 May 2024
  2. Study start23 Aug 2024
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2031 (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
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06413498
Sponsor's protocol ID
KT-US-679-0788
Other IDs
2024-511188-26, jRCT2043240170
Acronym
iMMagine-3
Status last verified
Jul 2026
First submitted
9 May 2024
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
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 Anitocabtagene Autoleucel, Cyclophosphamide and Fludarabine in people with Multiple Myeloma, run by Kite, A Gilead Company at 117 sites in 15 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 15 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Spain, France, Germany, Japan and 10 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 4 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 NCT06413498.

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 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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