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Bladder CancerPhase 1/2NCT06305767

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

A Phase 1/2 study testing Pembrolizumab, Intismeran autogene and Enfortumab Vedotin in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 74 sites in 16 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

Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Pembrolizumab, Intismeran autogene and Enfortumab Vedotin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
230 participants
Where
74 sitesin 16 countries
Study dates
28 Mar 2024to 20 Oct 2031
Phase
Phase 1/2
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

  • The main inclusion criteria include but are not limited to the following:
  • Has a histological diagnosis of urothelial carcinoma (UC)
  • Must provide blood samples per protocol, to enable intismeran autogene production, and circulating tumor deoxyribonucleic acid testing
  • Has an Eastern Cooperative Oncology Group performance status of 0 to 2 assessed within 7 days before randomization
  • Must provide a formalin-fixed paraffin-embedded tumor tissue sample for next generation sequencing
  • Adjuvant Cohort:
Show all 13Show fewer
  • Has MIUC
  • Has high-risk pathologic disease after radical resection
  • For participants who have not received cisplatin-based neoadjuvant chemotherapy, are ineligible to receive cisplatin according to protocol pre-defined criteria
  • Perioperative Cohort:
  • Has MIBC
  • Is deemed eligible for RC and PLND and agrees to undergo curative intent standard RC and PLND and neoadjuvant and adjuvant treatment per protocol
  • Is ineligible to receive cisplatin according to protocol pre-defined criteria

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has known additional malignancy that is progressing or has required active treatment ≤3 years prior to study randomization
  • Has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • Has active hepatitis B and hepatitis C virus infection
Show all 15Show fewer
  • Adjuvant Cohort:
  • Has received prior systemic anticancer therapy
  • Has received prior neoadjuvant therapy, with the exception of neoadjuvant cisplatin-based chemotherapy for MIUC
  • Has severe hypersensitivity to either intismeran autogene or pembrolizumab (MK-3475) and/or any of their excipients
  • Perioperative Cohort:
  • Has received any prior systemic treatment, cancer vaccine treatment, chemoradiation, and/or radiation therapy treatment for MIBC
  • Has severe hypersensitivity to either intismeran autogene, pembrolizumab, or EV and/or any of their excipients
  • Has ongoing sensory or motor neuropathy
  • Has active keratitis or corneal ulcerations

Trial locations and contacts

74 sites in 16 countries.

74 sites in 16 countries

United States10 sites

  • University of Chicago Medical Center ( Site 0109)

    Chicago, Illinois, 60637

  • Cleveland Clinic Main ( Site 0100)

    Cleveland, Ohio, 44195

  • UT Southwestern Medical Center ( Site 0103)

    Dallas, Texas, 75390

  • Duke Cancer Institute ( Site 0107)

    Durham, North Carolina, 27710

  • Houston Methodist Hospital-Department of Urology ( Site 0111)

    Houston, Texas, 77030

  • University of Iowa ( Site 0110)

    Iowa City, Iowa, 52242

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104)

    Los Angeles, California, 90095

  • Icahn School of Medicine at Mount Sinai ( Site 0101)

    New York, New York, 10029

  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102)

    Orlando, Florida, 32804

  • Fox Chase Cancer Center ( Site 0106)

    Philadelphia, Pennsylvania, 19111

Other trials in United States

Turkey (Türkiye)7 sites

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1200)

    Ankara, 06230

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 1204)

    Ankara, 06520

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1201)

    Ankara, 06800

  • Koc Universitesi Hastanesi ( Site 1206)

    Istanbul, 34025

  • T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1205)

    Istanbul, 34147

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1202)

    Istanbul, 34722

  • Ege Universitesi Hastanesi-Medical Oncology ( Site 1203)

    Izmir, 35100

Other trials in Turkey (Türkiye)

Canada5 sites

  • Centre Hospitalier de l'Université de Montréal ( Site 0005)

    Montreal, Quebec, H2X 3E4

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001)

    Québec, Quebec, G1J 1Z4

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002)

    Sherbrooke, Quebec, J1H 5H4

  • Princess Margaret Cancer Centre ( Site 0003)

    Toronto, Ontario, M5G 2M9

  • BC Cancer Vancouver ( Site 0004)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Chile5 sites

  • Bradfordhill-Clinical Area ( Site 1501)

    Recoleta, Santiago, Region M. de Santiago, 8420383

  • FALP ( Site 1500)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 1503)

    Santiago, Region M. de Santiago, 832000

  • CIDO SpA ( Site 1509)

    Temuco, Araucania, 4810148

  • ONCOCENTRO APYS-ACEREY ( Site 1506)

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

France5 sites

  • Institut de Cancérologie de l'Ouest ( Site 0300)

    Angers, Maine-et-Loire, 49055

  • Hopital Claude Huriez - CHU de Lille ( Site 0301)

    Lille, Nord, 59037

  • Hôpital Saint-Louis ( Site 0304)

    Paris, 75475

  • Oncopole Claudius Regaud ( Site 0302)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 0303)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Germany5 sites

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0400)

    Berlin, 10117

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)

    Dresden, Saxony, 01307

  • Universitätsklinikum Halle-Universitätsklinik und Poliklinik für Urologie ( Site 0402)

    Halle, Saxony-Anhalt, 06120

  • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0401)

    Munich, Bavaria, 81675

  • Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0404)

    Regensburg, Bavaria, 93053

Other trials in Germany

Italy5 sites

  • Ospedale San Martino-U.O. Oncologia Medica 1 ( Site 0500)

    Genoa, Liguria, 16132

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502)

    Milan, Lombardy, 20133

  • Ospedale San Raffaele-Oncologia Medica ( Site 0501)

    Milan, 20132

  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli-UOSC Oncologia ( Site 0503)

    Naples, Napoli, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504)

    Rome, Lazio, 00168

Other trials in Italy

Poland5 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0806)

    Kielce, Świętokrzyskie Voivodeship, SWK 25-734

  • Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0802)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0805)

    Poznan, Greater Poland Voivodeship, WLK 61-731

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 0800)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Spain5 sites

  • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006)

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 1002)

    Barcelona, 08035

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005)

    Madrid, Madrid, Comunidad de, 28034

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003)

    Pozuelo de Alarcón, Madrid, 28223

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001)

    Seville, 41013

Other trials in Spain

United Kingdom5 sites

  • Gartnavel General Hospital-Clinical Trials Unit ( Site 1301)

    Glasgow, Glasgow City, G12 0YN

  • Royal Free Hospital ( Site 1300)

    London, England, NW3 2QG

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1302)

    London, London, City of, EC1A 7BE

  • The Christie NHS Foundation Trust ( Site 1306)

    Manchester, M20 4BX

  • Torbay Hospital ( Site 1303)

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Australia4 sites

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)

    Macquarie University, New South Wales, 2109

  • One Clinical Research ( Site 1807)

    Nedlands, Western Australia, 6009

  • Mater Misericordiae Limited ( Site 1808)

    South Brisbane, Queensland, 4101

  • Westmead Hospital ( Site 1802)

    Westmead, New South Wales, 2145

Other trials in Australia

Colombia4 sites

  • Instituto Nacional De Cancerologia-Oncología Clínica ( Site 1606)

    Bogota, Cundinamarca, 111151

  • Clínica Universitaria Colombia ( Site 1600)

    Bogotá, Bogota D.C., 111321

  • Fundacion Valle del Lili- CIC-Oncology CIC ( Site 1608)

    Cali, Valle del Cauca Department, 760032

  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1605)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Peru3 sites

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1702)

    Lima, 15036

  • Oncosalud ( Site 1701)

    Lima, 15036

  • Hospital Militar Central Luis Arias Schereiber ( Site 1700)

    Lima, 1507

Other trials in Peru

South Korea3 sites

  • Korea University Anam Hospital ( Site 2002)

    Seoul, 02841

  • Seoul National University Hospital-Urology ( Site 2000)

    Seoul, 03080

  • Samsung Medical Center-Urology ( Site 2001)

    Seoul, 06351

Other trials in South Korea

Sweden2 sites

  • Karolinska Universitetssjukhuset Solna ( Site 1101)

    Stockholm, Stockholm County, 171 64

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

New Zealand1 site

  • Auckland City Hospital ( Site 1901)

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)

Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy before surgery, then surgery to remove the cancer. Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing. After surgery, some people receive more treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Enfortumab vedotin (EV) is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to learn if giving intismeran autogene (the study treatment) with pembrolizumab can prevent MIUC from returning after surgery. Intismeran autogene (also called mRNA-4157) is designed to treat each person's cancer by helping the person's immune system identify and kill cancer cells based on certain proteins found on those cancer cells.

The goals of this study are to learn if people who receive intismeran autogene and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of intismeran autogene, pembrolizumab, and EV, and if people tolerate them.

Read the detailed description

Enrollment of participants into the Phase 1 Perioperative Cohort of this study is planned to start in approximately April of 2025.

Conditions
Bladder Cancer
Being tested
Pembrolizumab, Intismeran autogene, Placebo, Enfortumab Vedotin, Surgery (RC plus PLND)
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Urinary Bladder Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

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

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    Administered via intravenous (IV) infusion at a dose of 400 mg on Day 1 of every 6-week cycle for up to 9 adjuvant cycles for Adjuvant Cohort participants, or at a dose of 200 mg on Day 1 of every cycle for up to four 3-week neoadjuvant cycles and up to thirteen 3-week adjuvant cycles for Perioperative Cohort participants.

  • Intismeran autogeneBiological

    Also called V940

    Administered via intramuscular (IM) injection at a dose of 1 mg every 3 weeks for a total of up to 9 adjuvant doses for Adjuvant Cohort participants, or at a dose of 1 mg every 3 weeks for a total of up to 9 doses in the neoadjuvant and adjuvant periods for Perioperative Cohort participants.

  • PlaceboOther

    Intismeran autogene diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.

  • Enfortumab VedotinBiological

    Also called PADCEV®

    Administered via IV infusion at a dose of 1.25 mg/kg on Day 1 and Day 8 of every cycle for up to four 3-week neoadjuvant cycles and up to five 3-week adjuvant cycles for Perioperative Cohort participants.

  • Surgery (RC plus PLND)Procedure or surgery

    Curative intent surgery (RC plus PLND) will be administered to all participants in the Perioperative Cohort and will be done in accordance with the American Urological Association/American Society for Radiation Oncology/American Society of Clinical Oncology/Society of Urologic Oncology guidelines. RC plus PLND will be performed within 6 weeks of the last dose of neoadjuvant intismeran autogene plus pembrolizumab plus EV treatment. Adjuvant intismeran autogene plus pembrolizumab plus EV treatment will begin within 8 weeks of completing RC plus PLND.

Study groups in NCT06305767
Study groupRoleWhat they receive
Adjuvant Cohort: Pembrolizumab + Intismeran autogeneExperimentalAdjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of intismeran autogene. Intismeran autogene doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
Receives: Biological: Pembrolizumab; Biological: Intismeran autogene
Adjuvant Cohort: Pembrolizumab + PlaceboActive comparatorAdjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of placebo. Placebo doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
Receives: Biological: Pembrolizumab; Other: Placebo
Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and SurgeryExperimentalParticipants will receive neoadjuvant treatment with up to 4 cycles of pembrolizumab plus EV and 1 to 4 doses of intismeran autogene, followed by radical cystectomy [RC] plus pelvic lymph node dissection [PLND], and then adjuvant treatment with up to 13 cycles of pembrolizumab plus up to 5 cycles of EV and 5 to 8 doses of intismeran autogene (for a total of 9 neoadjuvant plus adjuvant Intismeran autogene doses), or until any of the protocol-specified criteria for discontinuation of study intervention are met. The total duration of treatment is up to approximately 16 months.
Receives: Biological: Pembrolizumab; Biological: Intismeran autogene; Biological: Enfortumab Vedotin; Procedure: Surgery (RC plus PLND)

What is being measured

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

  1. Adjuvant Cohort: Disease Free Survival (DFS)

    DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease or any high-grade non-muscle invasive disease in the urothelial tract (upper tract or lower tract) on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for the Adjuvant Cohort.

    Measured: Up to approximately 28 months

  2. Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience AEs will be reported for the Perioperative Cohort.

    Measured: Up to approximately 19 months

  3. Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be reported for the Perioperative Cohort.

    Measured: Up to approximately 16 months

Secondary outcomes (6)

  1. Adjuvant Cohort: Overall Survival (OS)

    Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for the Adjuvant Cohort.

    Measured: Up to approximately 28 months

  2. Adjuvant Cohort: Distant Metastasis-Free Survival (DMFS)

    DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for the Adjuvant Cohort.

    Measured: Up to approximately 28 months

  3. Adjuvant Cohort: Number of Participants Who Experience an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for the Adjuvant Cohort.

    Measured: Up to approximately 16 months

  4. Adjuvant Cohort: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be presented for the Adjuvant Cohort.

    Measured: Up to approximately 13 months

  5. Perioperative Cohort: Pathologic Complete Response (pCR) Rate

    pCR is defined as the absence of viable tumor (pT0N0) in examined tissue from RC plus PLND as assessed by the investigator. pCR rate will be reported as the percentage of participants in the Perioperative Cohort having pCR.

    Measured: Up to approximately 18 weeks

  6. Perioperative Cohort: Pathologic Downstaging (pDS) Rate

    pDS is defined as participants with <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC plus PLND as assessed by the investigator. pDS rate will be reported as the percentage of participants in the Perioperative Cohort having pDS.

    Measured: Up to approximately 18 weeks

Timeline

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

  1. First posted12 Mar 2024
  2. Study start28 Mar 2024
  3. Primary completion23 Apr 2027 (estimated)
  4. Study completion20 Oct 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Phase 2 Adjuvant Cohort is a placebo- and active-controlled, parallel-group, multicenter, double-blind safety and efficacy study of adjuvant intismeran autogene plus pembrolizumab versus adjuvant placebo plus pembrolizumab in participants with pathologic high-risk MIUC after radical resection. Eligible participants will be randomly assigned in a 1:1 ratio to receive treatment with either intismeran autogene plus pembrolizumab or placebo plus pembrolizumab. The Phase 1 Perioperative Cohort of this study has a single arm into which eligible participants are allocated. It will evaluate safety and preliminary efficacy of perioperative (neoadjuvant and adjuvant) intismeran autogene in combination with pembrolizumab plus EV for participants with muscle-invasive bladder cancer (MIBC).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305767
Sponsor's protocol ID
V940-005
Other IDs
V940-005, U1111-1292-1952, 2023-505658-17-00, INTerpath-005, 2023
Status last verified
Jan 2026
First submitted
5 Mar 2024
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab, Intismeran autogene and Enfortumab Vedotin in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 74 sites in 16 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 13 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Turkey (Türkiye), Canada, Chile, France and 11 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Adjuvant Cohort: Disease Free Survival (DFS) (time frame: Up to approximately 28 months). The study lists 3 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 NCT06305767.

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 13 Jan 2026.

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