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An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC (TU-04)

17. juli 2026 opdateret af: AstraZeneca

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.

Study details:

Duration: ~78 months (6.5 years) from FSI to last subject visit Treatment length: up to ~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

915

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
      • Auchenflower, Australien, 4066
        • Trukket tilbage
        • Research Site
      • Ballarat, Australien, 3350
        • Ikke rekrutterer endnu
        • Research Site
      • Clayton, Australien, 3168
        • Ikke rekrutterer endnu
        • Research Site
      • Darlinghurst, Australien, 2010
        • Ikke rekrutterer endnu
        • Research Site
      • Elizabeth Vale, Australien, 5112
        • Ikke rekrutterer endnu
        • Research Site
      • South Brisbane, Australien, 4101
        • Ikke rekrutterer endnu
        • Research Site
      • St Albans, Australien, 3021
        • Trukket tilbage
        • Research Site
  • Brasilien
      • Barretos, Brasilien, 14784-400
        • Ikke rekrutterer endnu
        • Research Site
      • Curitiba, Brasilien, 81520-060
        • Ikke rekrutterer endnu
        • Research Site
      • Salvador, Brasilien, 41950-640
        • Ikke rekrutterer endnu
        • Research Site
      • São Paulo, Brasilien, 05652-900
        • Ikke rekrutterer endnu
        • Research Site
      • São Paulo, Brasilien, 01323-903
        • Ikke rekrutterer endnu
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Ikke rekrutterer endnu
        • Research Site
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada, V2S0C2
        • Ikke rekrutterer endnu
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Rekruttering
        • Research Site
      • Hamilton, Ontario, Canada, L8V 5C2
        • Rekruttering
        • Research Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Ikke rekrutterer endnu
        • Research Site
      • London, Ontario, Canada, N6C 2R5
        • Ikke rekrutterer endnu
        • Research Site
      • Mississauga, Ontario, Canada, L5M 2N1
        • Ikke rekrutterer endnu
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Ikke rekrutterer endnu
        • Research Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Ikke rekrutterer endnu
        • Research Site
  • Det Forenede Kongerige
      • Bristol, Det Forenede Kongerige, BS2 8ED
        • Ikke rekrutterer endnu
        • Research Site
      • Cambridge, Det Forenede Kongerige, CB2 0QQ
        • Ikke rekrutterer endnu
        • Research Site
      • Preston, Det Forenede Kongerige, PR2 9HT
        • Ikke rekrutterer endnu
        • Research Site
      • Sheffield, Det Forenede Kongerige, S10 2SJ
        • Ikke rekrutterer endnu
        • Research Site
  • Forenede Stater
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Ikke rekrutterer endnu
        • Research Site
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Ikke rekrutterer endnu
        • Research Site
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Ikke rekrutterer endnu
        • Research Site
    • California
      • San Francisco, California, Forenede Stater, 94143
        • Ikke rekrutterer endnu
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Trukket tilbage
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Ikke rekrutterer endnu
        • Research Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64132
        • Ikke rekrutterer endnu
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68506
        • Ikke rekrutterer endnu
        • Research Site
      • Omaha, Nebraska, Forenede Stater, 68130
        • Ikke rekrutterer endnu
        • Research Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Ikke rekrutterer endnu
        • Research Site
      • New York, New York, Forenede Stater, 10065
        • Ikke rekrutterer endnu
        • Research Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Ikke rekrutterer endnu
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Ikke rekrutterer endnu
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Ikke rekrutterer endnu
        • Research Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Ikke rekrutterer endnu
        • Research Site
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Ikke rekrutterer endnu
        • Research Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Ikke rekrutterer endnu
        • Research Site
      • Tacoma, Washington, Forenede Stater, 98405
        • Ikke rekrutterer endnu
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Ikke rekrutterer endnu
        • Research Site
  • Frankrig
      • Bordeaux, Frankrig, 33000
        • Ikke rekrutterer endnu
        • Research Site
      • Montpellier, Frankrig, 34298
        • Ikke rekrutterer endnu
        • Research Site
      • Paris, Frankrig, 75014
        • Ikke rekrutterer endnu
        • Research Site
      • Pierre-Bénite, Frankrig, 69310
        • Ikke rekrutterer endnu
        • Research Site
      • Poitiers, Frankrig, 86000
        • Ikke rekrutterer endnu
        • Research Site
      • Strasbourg, Frankrig, 67098
        • Ikke rekrutterer endnu
        • Research Site
  • Indien
      • Kolkata, Indien, 700160
        • Ikke rekrutterer endnu
        • Research Site
      • Kottayam, Indien, 686008
        • Ikke rekrutterer endnu
        • Research Site
      • Nashik, Indien, 422011
        • Ikke rekrutterer endnu
        • Research Site
      • Navi Mumbai, Indien, 410210
        • Ikke rekrutterer endnu
        • Research Site
      • New Delhi, Indien, 110085
        • Ikke rekrutterer endnu
        • Research Site
      • New Delhi, Indien, 110076
        • Ikke rekrutterer endnu
        • Research Site
      • New Delhi, Indien, 11029
        • Ikke rekrutterer endnu
        • Research Site
  • Italien
      • Bari, Italien, 70120
        • Ikke rekrutterer endnu
        • Research Site
      • Florence, Italien, 50134
        • Ikke rekrutterer endnu
        • Research Site
      • Padova, Italien, 35128
        • Ikke rekrutterer endnu
        • Research Site
      • Roma, Italien, 00168
        • Ikke rekrutterer endnu
        • Research Site
      • Rozzano, Italien, 20089
        • Ikke rekrutterer endnu
        • Research Site
      • Tricase, Italien, 73039
        • Ikke rekrutterer endnu
        • Research Site
  • Japan
      • Fukuoka, Japan, 812-8582
        • Ikke rekrutterer endnu
        • Research Site
      • Fukuoka, Japan, 811-1347
        • Ikke rekrutterer endnu
        • Research Site
      • Hamamatsu, Japan, 431-3192
        • Ikke rekrutterer endnu
        • Research Site
      • Hirosaki-shi, Japan, 036-8563
        • Trukket tilbage
        • Research Site
      • Kanazawa, Japan, 920-8641
        • Ikke rekrutterer endnu
        • Research Site
      • Kashihara-shi, Japan, 634-8522
        • Ikke rekrutterer endnu
        • Research Site
      • Kawasaki-shi, Japan, 216-8511
        • Ikke rekrutterer endnu
        • Research Site
      • Kita-gun, Japan, 761-0793
        • Trukket tilbage
        • Research Site
      • Kobe, Japan, 650-0017
        • Ikke rekrutterer endnu
        • Research Site
      • Kumamoto, Japan, 860-0008
        • Ikke rekrutterer endnu
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Ikke rekrutterer endnu
        • Research Site
      • Nagasaki, Japan, 852-8501
        • Ikke rekrutterer endnu
        • Research Site
      • Nagoya, Japan, 466-8560
        • Ikke rekrutterer endnu
        • Research Site
      • Osaka, Japan, 545-8586
        • Ikke rekrutterer endnu
        • Research Site
      • Osaka, Japan, 541-8567
        • Ikke rekrutterer endnu
        • Research Site
      • Toyama, Japan, 930-0194
        • Ikke rekrutterer endnu
        • Research Site
      • Tsukuba, Japan, 305-8576
        • Ikke rekrutterer endnu
        • Research Site
  • Kina
      • Beijing, Kina, 100050
        • Ikke rekrutterer endnu
        • Research Site
      • Beijing, Kina, 100191
        • Ikke rekrutterer endnu
        • Research Site
      • Beijing, Kina, 100034
        • Ikke rekrutterer endnu
        • Research Site
      • Changsha, Kina, 410013
        • Ikke rekrutterer endnu
        • Research Site
      • Chengdu, Kina, 610072
        • Ikke rekrutterer endnu
        • Research Site
      • Chengdu, Kina, 610000
        • Ikke rekrutterer endnu
        • Research Site
      • Chongqing, Kina, 400030
        • Ikke rekrutterer endnu
        • Research Site
      • Chongqing, Kina, 400016
        • Ikke rekrutterer endnu
        • Research Site
      • Fuzhou, Kina, 350005
        • Ikke rekrutterer endnu
        • Research Site
      • Guangzhou, Kina, 510220
        • Ikke rekrutterer endnu
        • Research Site
      • Guangzhou, Kina, 510288
        • Ikke rekrutterer endnu
        • Research Site
      • Guiyang, Kina, 550044
        • Ikke rekrutterer endnu
        • Research Site
      • Hangzhou, Kina, 310003
        • Ikke rekrutterer endnu
        • Research Site
      • Hangzhou, Kina, 310009
        • Ikke rekrutterer endnu
        • Research Site
      • Harbin, Kina, 150049
        • Ikke rekrutterer endnu
        • Research Site
      • Jinan, Kina, 250012
        • Ikke rekrutterer endnu
        • Research Site
      • Jinan, Kina, 250021
        • Ikke rekrutterer endnu
        • Research Site
      • Kunming, Kina, 650101
        • Ikke rekrutterer endnu
        • Research Site
      • Kunming, Kina, 650118
        • Ikke rekrutterer endnu
        • Research Site
      • Lanzhou, Kina, 730030
        • Ikke rekrutterer endnu
        • Research Site
      • Nanchang, Kina, 330006
        • Ikke rekrutterer endnu
        • Research Site
      • Nanjing, Kina, 210008
        • Ikke rekrutterer endnu
        • Research Site
      • Nanning, Kina, 530021
        • Ikke rekrutterer endnu
        • Research Site
      • Ningbo, Kina, 315010
        • Ikke rekrutterer endnu
        • Research Site
      • Qingdao, Kina, 266003
        • Ikke rekrutterer endnu
        • Research Site
      • Shanghai, Kina, 200040
        • Ikke rekrutterer endnu
        • Research Site
      • Shenyang, Kina, 110042
        • Ikke rekrutterer endnu
        • Research Site
      • Shenyang, Kina, 110004
        • Ikke rekrutterer endnu
        • Research Site
      • Suining Shi, Kina, 629000
        • Ikke rekrutterer endnu
        • Research Site
      • Tianjin, Kina, 300211
        • Ikke rekrutterer endnu
        • Research Site
      • Wenzhou, Kina, 325000
        • Ikke rekrutterer endnu
        • Research Site
      • Wuhan, Kina, 430022
        • Ikke rekrutterer endnu
        • Research Site
      • Wuhan, Kina, 430030
        • Ikke rekrutterer endnu
        • Research Site
      • Xuzhou, Kina, 221000
        • Ikke rekrutterer endnu
        • Research Site
      • Zhengzhou, Kina, 450008
        • Ikke rekrutterer endnu
        • Research Site
  • Polen
      • Gdansk, Polen, 80-952
        • Ikke rekrutterer endnu
        • Research Site
      • Koszalin, Polen, 75-581
        • Ikke rekrutterer endnu
        • Research Site
      • Poznan, Polen, 61-731
        • Ikke rekrutterer endnu
        • Research Site
      • Siedlce, Polen, 08-110
        • Ikke rekrutterer endnu
        • Research Site
      • Skórzewo, Polen, 60-185
        • Ikke rekrutterer endnu
        • Research Site
      • Wroclaw, Polen, 53-413
        • Ikke rekrutterer endnu
        • Research Site
      • Wroclaw, Polen, 50-556
        • Ikke rekrutterer endnu
        • Research Site
  • Spanien
      • L'Hospitalet de Llobregat, Spanien, 08908
        • Ikke rekrutterer endnu
        • Research Site
      • Las Palmas de Gran Canaria, Spanien, 35016
        • Ikke rekrutterer endnu
        • Research Site
      • Madrid, Spanien, 28040
        • Ikke rekrutterer endnu
        • Research Site
      • Santander, Spanien, 39008
        • Ikke rekrutterer endnu
        • Research Site
      • Seville, Spanien, 41013
        • Ikke rekrutterer endnu
        • Research Site
  • Sydkorea
      • Seoul, Sydkorea, 3722
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 03080
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 06591
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 5505
        • Ikke rekrutterer endnu
        • Research Site
      • Seoul, Sydkorea, 6351
        • Ikke rekrutterer endnu
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Rekruttering
        • Research Site
      • Kaohsiung City, Taiwan, 83301
        • Ikke rekrutterer endnu
        • Research Site
      • Kaohsiung City, Taiwan, 813
        • Ikke rekrutterer endnu
        • Research Site
      • Tainan, Taiwan, 704
        • Ikke rekrutterer endnu
        • Research Site
      • Taipei, Taiwan, 11217
        • Ikke rekrutterer endnu
        • Research Site
      • Taoyuan, Taiwan, 333
        • Ikke rekrutterer endnu
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Ikke rekrutterer endnu
        • Research Site
      • Hat Yai, Thailand, 90110
        • Ikke rekrutterer endnu
        • Research Site
  • Tyskland
      • Bochum, Tyskland, 44791
        • Ikke rekrutterer endnu
        • Research Site
      • Bonn, Tyskland, 53127
        • Ikke rekrutterer endnu
        • Research Site
      • Dresden, Tyskland, 01307
        • Ikke rekrutterer endnu
        • Research Site
      • Duisburg, Tyskland, 47169
        • Ikke rekrutterer endnu
        • Research Site
      • Frankfurt am Main, Tyskland, 60431
        • Ikke rekrutterer endnu
        • Research Site
      • Hamburg, Tyskland, 20246
        • Ikke rekrutterer endnu
        • Research Site
      • Hanover, Tyskland, 30625
        • Ikke rekrutterer endnu
        • Research Site
      • Herne, Tyskland, 44625
        • Ikke rekrutterer endnu
        • Research Site
      • Magdeburg, Tyskland, 39120
        • Ikke rekrutterer endnu
        • Research Site
      • Mannheim, Tyskland, 68167
        • Ikke rekrutterer endnu
        • Research Site
      • Marburg, Tyskland, 35043
        • Ikke rekrutterer endnu
        • Research Site
      • Mettmann, Tyskland, 40822
        • Ikke rekrutterer endnu
        • Research Site
      • Münster, Tyskland, 48149
        • Ikke rekrutterer endnu
        • Research Site
      • Nuremberg, Tyskland, 90419
        • Ikke rekrutterer endnu
        • Research Site
      • Nürtingen, Tyskland, 72622
        • Ikke rekrutterer endnu
        • Research Site
      • Regensburg, Tyskland, 93053
        • Ikke rekrutterer endnu
        • Research Site
      • Rostock, Tyskland, 18057
        • Ikke rekrutterer endnu
        • Research Site
      • Stuttgart, Tyskland, 70174
        • Ikke rekrutterer endnu
        • Research Site
      • Tübingen, Tyskland, 72076
        • Ikke rekrutterer endnu
        • Research Site
      • Ulm, Tyskland, 89081
        • Ikke rekrutterer endnu
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion criteria:

  1. Participant must be > 18 years of age at the time of signing the ICF.
  2. Histologically confirmed MIUC of the bladder or upper tract.
  3. Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease.

  4. Pathologic evidence of urothelial carcinoma at high-risk of recurrence and

    1. not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage
    2. completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage
  5. No evidence of disease at screening,
  6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
  7. Minimum life expectancy of > 12 weeks at time of screening.
  8. An archival surgical tumour sample must be available pre-randomisation for central testing.
  9. Adequate organ and bone marrow function within 28 days before randomisation.

Exclusion criteria:

  1. Any tumour with predominant or pure high grade neuroendocrine carcinoma component.
  2. Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy.
  3. Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma.
  4. Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse.
  5. History of clinically significant corneal disease.
  6. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention and of low potential risk for recurrence.
  7. Ongoing toxicities except alopecia from prior cancer treatment must be Grade ≤ 1 or at baseline. Stable Grade 2 toxicities are allowed if unchanged for ≥3 months and managed by standard care.
  8. Active or uncontrolled hepatitis B or C virus infection.
  9. Known HIV infection that is not well controlled.
  10. Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisation.
  11. History of non-infectious ILD/pneumonitis including radiation, pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  12. Has clinically severe pulmonary function compromise.
  13. Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening
  14. Uncontrolled or significant cardiac conditions.
  15. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years.
  16. Prior exposure to TROP2-directed therapies, other ADCs with deruxtecan, therapeutic anti-cancer vaccines, anti-TIGIT therapy or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms.
  17. Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation.
  18. Known history of severe hypersensitivity reactions to any study drug
  19. Not eligible to receive at least one of SoC according to local regulations/approvals.
  20. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1: Dato-DXd + rilvegostomig
Dato-DXd: 6 mg/kg IV Q3W for 9 cycles (approximately 6 months), can be extended based on Investigator assessment of tolerability up to 17 cycles or up to 1 year + rilvegostomig: 750 mg IV Q3W 17 cycles or up to 1 year whichever occurs first.
Medicin: Dato-DXd
Dato-DXd is an ADC comprised of a recombinant humanised anti-TROP2 IgG1 mAb, MAAP-9001a, which is covalently conjugated via a cleavable drug-linker, MAAA1162a (the complex of MAAA-1181a and a maleimide tetrapeptide linker), using thioether bonds to the topoisomerase I inhibitor DXd.
Andre navne:
  • Datopotamab deruxtecan
  • (Dato-DXd, DS-1062a)
Medicin: Rilvegostomig
Rilvegostomig is a monovalent, bispecific, humanised, IgG1 mAb engineered with an Fc domain that carries a triple mutation (L234F/L235E/P331S) designed to reduce Fc-mediated effector functions. Rilvegostomig contains 2 distinct paratopes that bind to human TIGIT and PD-1 and inhibit binding to their respective immuno-suppressive ligands.
Andre navne:
  • AZD2936
Eksperimentel: Arm 2: Dato-DXd monotherapy
Dato-DXd: 6 mg/kg IV Q3W for 9 cycles (approximately 6 months), can be extended based on Investigator assessment of tolerability up to 17 cycles or up to 1 year.
Medicin: Dato-DXd
Dato-DXd is an ADC comprised of a recombinant humanised anti-TROP2 IgG1 mAb, MAAP-9001a, which is covalently conjugated via a cleavable drug-linker, MAAA1162a (the complex of MAAA-1181a and a maleimide tetrapeptide linker), using thioether bonds to the topoisomerase I inhibitor DXd.
Andre navne:
  • Datopotamab deruxtecan
  • (Dato-DXd, DS-1062a)
Aktiv komparator: Arm 3 (SoC): nivolumab or durvalumab or EV + pembrolizumab

Either: Nivolumab: 240 mg IV Q2W OR 480 mg IV Q4W up to 1 year

Or: Durvalumab: 1500 mg IV Q4W for 8 cycles (or at a dose of 20 mg/kg Q4W in participants who weigh ≤ 30 kg)

Or: EV 1.25 mg/kg D1, D8 Q3W up to 6 cycles + pembrolizumab 200 mg IV Q3W up to 14 cycles or 400 mg IV Q6W up to 7 cycles.
Medicin: Durvalumab
A fully human monoclonal antibody that blocks the PD-L1 checkpoint to restore anti-tumor T-cell activity. Durvalumab is approved for Muscle invasive bladder cancer (MIBC) as perioperative regime.
Andre navne:
  • Imfinzi, MEDI4736
Medicin: Nivolumab
A fully human monoclonal antibody against PD-1, promoting anti-tumor immunity. Approved across many malignancies such as melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, hepatocellular carcinoma, and colorectal cancer (dMMR/MSI-H), often alone or with ipilimumab. It's used in several cancers, notably unresectable stage III non-small cell lung cancer after chemoradiation and extensive-stage small cell lung cancer in combination regimens, among others, and is also approved for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence in the adjuvant setting.
Andre navne:
  • OPDIVO®, BMS-936558
Medicin: Pembrolizumab
A humanized monoclonal antibody targeting PD-1, enhancing T-cell-mediated immune responses against tumors. Indications span multiple cancers including melanoma, NSCLC, head and neck squamous cell carcinoma, urothelial carcinoma, MSI-H/dMMR tumors, and more.
Andre navne:
  • Keytruda, MK-3475
Medicin: Enfortumab vedotin

An antibody-drug conjugate (ADC) comprised of a fully human anti-Nectin-4 IgG1 monoclonal antibody, linked via a protease-cleavable maleimide-based linker to the microtubule-disrupting agent monomethyl auristatin E (MMAE), which is conjugated through thioether bonds.

Upon binding to Nectin-4-expressing cells, the ADC is internalized and releases MMAE, leading to disruption of microtubule dynamics and subsequent tumor cell death. Enfortumab vedotin is approved in urothelial cancers.

Andre navne:
  • Padcev®, ASG-22CE, AGS-22M6E

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of disease-free survival (DFS) (based on Investigator assessments).
Tidsramme: From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by Investigator, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of OS (Overall survival).
Tidsramme: OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
OS defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants as randomised. All deaths will be included regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.
OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
To demonstrate the superiority of Dato-DXd + rilvegostomig (Arm 1) relative to SoC (Arm 3) by assessment of DFS (based on Blinded Independent Central Review [BICR] assessments).
Tidsramme: From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
To estimate the effectiveness of Dato-DXd monotherapy (Arm 2) versus SoC (Arm 3) and effectiveness of Dato-DXd in combination with rilvegostomig (Arm 1) versus Dato-DXd monotherapy (Arm 2) by assessment of OS.
Tidsramme: OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
OS defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants as randomised. All deaths will be included regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.
OS is defined as the time from randomisation until the date of death due to any cause, up to 78 months from first subject in.
To estimate the effectiveness of Dato-DXd monotherapy (Arm 2) versus SoC (Arm 3) and effectiveness of Dato-DXd in combination with rilvegostomig (Arm 1) versus Dato-DXd monotherapy (Arm 2) by assessment of DFS based on Investigator assessments.
Tidsramme: From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by Investigator, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by investigator or death due to any cause (anticipated to be up to 49 months after the first subject in).
To estimate the effectiveness of Dato-DXd monotherapy (Arm 2) versus SoC (Arm 3) and effectiveness of Dato-DXd in combination with rilvegostomig (Arm 1) versus Dato-DXd monotherapy (Arm 2) by assessment of DFS by BICR.
Tidsramme: From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
DFS is defined as the time from randomisation until disease recurrence (local urothelial tract, local non urothelial tract or distant) per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant discontinues study treatment or receives another anti-cancer therapy. The measure of interest is the HR of DFS.
From randomisation until disease recurrence as assessed by BICR or death due to any cause (anticipated to be up to 49 months after the first subject in).
To demonstrate effectiveness of Dato-DXd + rilvegostomig (Arm 1) vs SoC (Arm 3) by evaluating DSS (Disease specific survival), NUTRFS (Non-urothelial tract recurrence-free survival), DMFS (Distant metastasis free survival).
Tidsramme: From randomisation up to 49 months after the first subject in.

DSS is defined as time from randomisation until death due to disease (urothelial cancer). The analysis will include all randomised participants as randomised. The measure of interest is the HR of DSS.

NUTRFS is defined as time from randomisation until first local non-urothelial tract or distant recurrence or death due to any cause. The analysis will include all randomised participants as randomised. The measure of interest is the HR of NUTRFS.

DMFS is defined as time from randomisation until first distant recurrence (non-local) or death due to any cause The analysis will include all randomised participants as randomised. The measure of interest is the HR of DMFS.
From randomisation up to 49 months after the first subject in.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the pharmacokinetics (PK) of Dato-DXd and DXd, alone in the Dato-DXd monotherapy arm (Arm 2) and in combination with rilvegostomig (Arm 1). To assess the PK of rilvegostomig in Arm 1.
Tidsramme: Day 1 of Cycles 1, 2, 4, 5, and 8 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
Concentration of Dato-DXd and DXd in plasma. Concentration of rilvegostomig in serum.
Day 1 of Cycles 1, 2, 4, 5, and 8 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
To investigate the immunogenicity of Dato-DXd and rilvegostomig in Dato-DXd + rilvegostomig combination therapy (Arm 1) and Dato-DXd monotherapy (Arm 2).
Tidsramme: Day 1 of Cycles 1, 2, 4, 5, 6, 8, 10, and 14 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
Presence of antidrug antibody (ADA) for Dato-DXd in plasma and rilvegostomig in serum (confirmatory results: positive or negative, titres).
Day 1 of Cycles 1, 2, 4, 5, 6, 8, 10, and 14 (each cycle is 21 days), at the end of treatment (approximately up to 12 months after randomization), and at the end of safety follow-up (approximately up to 15 months after randomization).
To assess participant-reported global health status (GHS)/quality of life (QoL) in participants treated with Dato-DXd + rilvegostomig (Arm 1) as compared with SoC (Arm 3).
Tidsramme: D1C1, then every 3w (21d cycles) until end of treatment (~12m from randomization); thereafter every 6w after treatment discontinuation until recurrence, start of subsequent therapy, or study discontinuation, up to 18m post-treatment.
Proportion of participants with maintained or improved GHS/QoL as measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) GHS/QoL subscale (EORTC IL6) at each time point.
D1C1, then every 3w (21d cycles) until end of treatment (~12m from randomization); thereafter every 6w after treatment discontinuation until recurrence, start of subsequent therapy, or study discontinuation, up to 18m post-treatment.
Safety of adjuvant Dato-DXd in combination with rilvegostomig as compared with Dato-DXd monotherapy and SoC.
Tidsramme: From randomization through the end of treatment (approximately up to 12 months after randomization) and through the end of safety follow-up (approximately up to 15 months after randomization).
Safety will be evaluated in terms of AEs.
From randomization through the end of treatment (approximately up to 12 months after randomization) and through the end of safety follow-up (approximately up to 15 months after randomization).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Samarbejdspartnere

Daiichi Sankyo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juli 2026

Primær færdiggørelse (Anslået)

11. september 2030

Studieafslutning (Anslået)

23. november 2032

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D763TC00001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingstidsramme

Study start to completion date

IPD-delingsadgangskriterier

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Understøttende informationstype

  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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