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AzTrials

Metastatic Colorectal CancerPhase 3NCT07549412

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

A Phase 3 study testing Precemtabart tocentecan, Bevacizumab and Trifluridine/Tipiracil (FTD-TPI) in people with Metastatic Colorectal Cancer, run by EMD Serono Research & Development Institute, Inc. at 116 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
Search all trials

Trial summary

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Precemtabart tocentecan, Bevacizumab and Trifluridine/Tipiracil (FTD-TPI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,020 participants
Where
116 sitesin 19 countries
Study dates
6 May 2026to 16 Oct 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
  • Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
  • Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations
  • Other protocol defined inclusion criteria may apply

Who cannot join

  • If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0
  • Participant has a history of additional malignancy within 3 years before randomization
  • Participants with known brain metastases
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
  • Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments
  • Other protocol defined exclusion criteria may apply

Trial locations and contacts

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

US Medical Information contact

888-275-7376

eMediUSA@emdserono.com

Communication Center contact

+49 6151 72 5200

service@emdgroup.com

116 sites in 19 countries

United States22 sites, 22 recruiting

  • Texas Oncology, P.A. - Abilene - 300210366

    Abilene, Texas, 79606

    Recruiting

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

    Recruiting

  • Texas Oncology-South Austin

    Austin, Texas, 78745

    Recruiting

  • Texas Oncology DFW

    Bedford, Texas, 75246

    Recruiting

  • Missouri Cancer Associates - 150518964

    Columbia, Missouri, 65201

    Recruiting

  • Florida Cancer Specialists-Broadway

    Fort Myers, Florida, 33901

    Recruiting

  • Prisma Health Cancer Institute, ITOR, CRU

    Greenville, South Carolina, 29605

    Recruiting

  • Rocky Mountain Cancer Centers, LLP- Aurora

    Lone Tree, Colorado, 80124

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

    Recruiting

  • Illinois CancerCare PC

    Peoria, Illinois, 61615-7822

    Recruiting

  • Blue Ridge Cancer Care - 300202915

    Roanoke, Virginia, 24014-2419

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Saint Louis Park, Minnesota, 55416

    Recruiting

  • Texas Oncology- San Antonio

    San Antonio, Texas, 78240

    Recruiting

  • UCSF Mount Zion Medical Ctr

    San Francisco, California, 94158

    Recruiting

  • Avera Cancer Institute - 300127370

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Recruiting

  • Florida Cancer Specialists - St. Petersburg Bayfront

    St. Petersburg, Florida, 33701-4553

    Recruiting

  • Profound Research LLC at Cancer and Leukemia Center

    Sterling Heights, Michigan, 48098

    Recruiting

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

    Recruiting

  • Florida Cancer Specialists East - FCS EAST - West Palm Beach

    West Palm Beach, Florida, 33401

    Recruiting

  • White Plains Hospital Medical and Wellness PRIME

    White Plains, New York, 10601

    Recruiting

Other trials in United States

China15 sites, 15 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725

    Hangzhou, Zhejiang, 310000

    Recruiting

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

    Recruiting

  • The University of Hong Kong - 1

    Hong Kong, Hong Kong, 00000

    Recruiting

  • Meizhou Peoples Hospital - 300164707

    Meizhou, Guangdong, 514031

    Recruiting

  • The First Affiliated Hospital of Nanchang University - Endocrine Secretion Department

    Nanchang, Jiangxi, 330006

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi Zhuang, 530021

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430060

    Recruiting

Other trials in China

France9 sites, 9 recruiting

  • Institut Bergonié - Service d'Oncologie Médicale

    Bordeaux, Gironde, 33076

    Recruiting

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen, Calvados, 14033

    Recruiting

  • Hopital Claude Huriez - CHU Lille - service d'oncologie medicale

    Lille, Nord, 59037

    Recruiting

  • Centre Leon Berard - Service d'Oncologie Medicale

    Lyon, Rhone, 69008

    Recruiting

  • Institut Paoli Calmettes - service d'oncologie medicale

    Marseille, Bouches-du-Rhône, 13009

    Recruiting

  • Groupe Hospitalier Pitie-Salpetriere - Service Hépato-Gastro-Entérologie

    Paris, 75013

    Recruiting

  • Hôpital Européen Georges Pompidou - Hématologie Oncologie

    Paris, 75015

    Recruiting

  • CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et Hépatologie

    Saint Priest En Jarez, Pays de la Loire Region, 42270

    Recruiting

  • Institut Gustave Roussy - Pathologies Digestives

    Villejuif, Val De Marne, 94805

    Recruiting

Other trials in France

Japan9 sites, 9 recruiting

  • National Cancer Center Hospital

    Chūōku, Tokyo-To, 104-0045

    Recruiting

  • NHO Kyushu Cancer Center - 300175822

    Fukuoka, Fukuoka, 811-1395

    Recruiting

  • Saitama Cancer Center - 300175812

    Kitaadachi-gun, Saitama, 362-0806

    Recruiting

  • Cancer Institute Hospital of JFCR

    Kōtoku, Tokyo-To, 135-8550

    Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541-8567

    Recruiting

  • Kindai University Hospital

    Sakai-shi, Osaka, 590-0197

    Recruiting

  • Shizuoka Cancer Center

    Sunto, Shizuoka, 411-8777

    Recruiting

  • Kanagawa Cancer Center - Dept of Gastroenterology

    Yokohama, Kanagawa, 241-8515

    Recruiting

Other trials in Japan

South Korea9 sites, 9 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangnam-do, 700-721

    Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea, Seoul St. Maryâ

    Seoul, 06591

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

  • Asan Medical Center

    Seoul, 138-736

    Recruiting

Other trials in South Korea

Italy8 sites, 8 recruiting

  • Azienda Ospedaliera Saverio De Bellis - 300205674

    Castellana Grotte, Bari, 70013

    Recruiting

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck

    Milan, 20162

    Recruiting

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia

    Naples, 80131

    Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento Oncoematologia

    Naples, 80131

    Recruiting

  • IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi

    Padova, 35128

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

    Pisa, 56126

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Rome, 00168

    Recruiting

  • IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

    San Giovanni Rotondo, Foggia, 71013

    Recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Reina Sofia - Dept of Oncology

    Córdoba, Córdoba, 14004

    Recruiting

  • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08906

    Recruiting

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid, 28041

    Recruiting

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

    Recruiting

Other trials in Spain

Taiwan7 sites, 7 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • China Medical University Hospital

    Taichung, 40447

    Recruiting

  • National Cheng Kung University Hospital - Internal Medicine

    Tainan, 70403

    Recruiting

  • Chi Mei Hospital, Liouying

    Tainan, 736

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

Argentina4 sites, 4 recruiting

  • Investigaciones Clinicas Moleculares ICM

    Ciudad Autonoma Buenos Aires, C1417DTB

    Recruiting

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE

    Recruiting

  • Centro Oncologico de Excelencia

    San Juan, 5400

    Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL

    Recruiting

Other trials in Argentina

Australia4 sites, 4 recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

    Recruiting

  • Icon Cancer Centre Chermside

    Chermside, Queensland, 4032

    Recruiting

  • Mater Misericordiae Ltd - PARENT

    South Brisbane, Queensland, 4101

    Recruiting

  • GenesisCare North Shore (Oncology)

    St Leonards, New South Wales, 2065

    Recruiting

Other trials in Australia

Belgium4 sites, 4 recruiting

  • Cliniques Universitaires Saint-Luc - STL

    Brussels, 1200

    Recruiting

  • Grand Hospital de Charleroi - PARENT

    Charleroi, 6000

    Recruiting

  • UZA - Account 3

    Edegem, 2650

    Recruiting

  • UZ Leuven

    Leuven, 03000

    Recruiting

Other trials in Belgium

Germany4 sites, 4 recruiting

  • Charité - Campus Charité Mitte - Medizinische Klinik II (Onkologie u. Haematologie)

    Berlin, 13353

    Recruiting

  • Krankenhaus Nordwest GmbH - Neurologische Klinik

    Frankfurt am Main, Hesse, 60488

    Recruiting

  • Haematologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 20249

    Recruiting

  • Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)

    Leipzig, Saxony, 04103

    Recruiting

Other trials in Germany

Canada3 sites, 3 recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

  • BC Cancer - Vancouver - BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

    Recruiting

Other trials in Canada

United Kingdom3 sites, 3 recruiting

  • Aberdeen Royal Infirmary - Dept of Oncology

    Aberdeen, Grampian Region, AB25 2ZN

    Recruiting

  • Sarah Cannon Research Institute UK

    London, Greater London, W1G 6AD

    Recruiting

  • The Christie Hospital - Dept of Oncology

    Manchester, Great Manchester, M20 4BX

    Recruiting

Other trials in United Kingdom

Austria2 sites, 2 recruiting

  • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

    Salzburg, 5020

    Recruiting

  • AKH - Medizinische Universität Wien - Klinik für Innere Medizin 1

    Vienna, 1090

    Recruiting

Other trials in Austria

Netherlands2 sites, 2 recruiting

  • Universitair Medisch Centrum Groningen - Cancer Center

    Groningen, 9713GZ

    Recruiting

  • Amphia Ziekenhuis, Molengracht - Parent

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

Poland2 sites, 2 recruiting

  • Wojewodzkie Centrum Onkologii

    Gdansk, 80-219

    Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie - Dept of Clinical Oncology and Oncology Clinic

    Krakow, 31-501

    Recruiting

Other trials in Poland

Denmark1 site, 1 recruiting

  • Ålborg Universitets Hospital - PARENT

    Herning, 7400

    Recruiting

Other trials in Denmark

Hong Kong1 site, 1 recruiting

  • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

    Hong Kong, 00000

    Recruiting

Other trials in Hong Kong

About this study

Official title: A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluridine/tipiracil (FTD-TPI) plus bevacizumab.

Being tested
Precemtabart tocentecan, Bevacizumab, Trifluridine/Tipiracil (FTD-TPI)
Keywords
CEACAM5, Antibody-drug conjugate, Exatecan, M9140, Precem-TcT
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Precemtabart tocentecanDrug

    Also called Precem-TcT

    Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.

  • BevacizumabDrug

    Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.

  • Trifluridine/Tipiracil (FTD-TPI)Drug

    FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.

Study groups in NCT07549412
Study groupRoleWhat they receive
Arm 1: Precemtabart tocentecan (Precem-TcT) MonotherapyExperimentalNot described
Receives: Drug: Precemtabart tocentecan
Arm 2: Precem-TcT plus BevacizumabExperimentalNot described
Receives: Drug: Precemtabart tocentecan; Drug: Bevacizumab
Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus BevacizumabActive comparatorNot described
Receives: Drug: Bevacizumab; Drug: Trifluridine/Tipiracil (FTD-TPI)

What is being measured

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

  1. Arm 1, 2 and 3: Overall Survival

    Measured: Time from date of randomization to death, assessed approximately up to average of 19 months

Secondary outcomes (9)

  1. Arm 1 and Arm 2: Overall Survival

    Measured: Time from date of randomization to death, assessed approximately up to average of 19 months

  2. Progression Free Survival (PFS)

    Measured: Time from randomization to the first occurrence of disease progression or death, whichever occurs first (assessed up to average of 19 months)

  3. Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

    Measured: Up to average of 19 months

  4. Duration of Response as Assessed by Investigator

    Measured: Time from first documentation of objective response to PD or death (assessed up to average of 19 months)

  5. Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events

    Measured: Up to average of 19 months

  6. Observed Concentration at End of Infusion (CEOI) Period

    Measured: At end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (Arm 1 and Arm 2 only; each cycle is for 21 days)

  7. Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough)

    Measured: At end of dosing interval on Cycle1Day1,Cycle2Day1,Cycle3Day1,Cycle4Day1, Cycle5Day1,Cycle6Day1,Cycle7Day1 until treatment discontinuation(assessed up to average of 19months (Arm 1 and Arm 2 only; each cycle is for 21 days)

  8. Number of Participants with Anti-Drug Antibody as measured by ADA assay

    Measured: Predose(-4to0 hours)on Cycle1Day1,Cycle2 Day1,Cycle 3Day1,Cycle4Day1, Cycle8Day1;thereafter every 4cycles until treatment discontinuation(assessed up to average of 19 months) (Arm 1 and Arm 2 only; each cycle is for 21 days)

  9. Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

    Measured: Baseline, Cycle 1 Day 1 and Day 1 of every new cycle until treatment discontinuation (assessed up to average of 19 months).

Timeline

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

  1. First posted24 Apr 2026
  2. Study start6 May 2026
  3. Primary completion16 Oct 2029 (estimated)
  4. Study completion16 Oct 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
1,020 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07549412
Sponsor's protocol ID
MS914001_0002
Other IDs
2025-524648-37-00, CTR20262356, jRCT2031260267, 2025
Status last verified
Nov 2026
First submitted
16 Apr 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD supporting publicly available results will be evaluated for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Precemtabart tocentecan, Bevacizumab and Trifluridine/Tipiracil (FTD-TPI) in people with Metastatic Colorectal Cancer, run by EMD Serono Research & Development Institute, Inc. at 116 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 5 inclusion and 6 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 5 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 116 sites in United States, China, France, Japan, South Korea 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 US Medical Information (888-275-7376, eMediUSA@emdserono.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm 1, 2 and 3: Overall Survival (time frame: Time from date of randomization to death, assessed approximately up to average of 19 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 NCT07549412.

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 5 Nov 2026.

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