Actively Recruiting
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Led by Daiichi Sankyo · Updated on 2026-05-14
630
Participants Needed
98
Research Sites
225 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment. This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
CONDITIONS
Official Title
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 18 years or older at the time of informed consent
- Histologically or cytologically confirmed unresectable locally advanced or metastatic urothelial carcinoma of bladder, renal pelvis, ureter, or urethra
- Predominantly urothelial histology including transitional cell carcinoma with squamous differentiation or mixed cell types
- Participants with nonclinically active prostate cancer allowed if no radiological metastasis and no rising PSA
- Must provide tumor tissue sample for biomarker testing, not from irradiated lesion unless at least 3 months after radiation and lesion increased or appeared
- Archival tumor tissue collected after most recent anticancer treatment and within 12 months before consent is preferred
- Eligible to receive cisplatin- or carboplatin-containing chemotherapy based on investigator judgment
- If previously treated with gemcitabine, carboplatin, or cisplatin in adjuvant/neoadjuvant setting, at least 1 year since last dose before trial treatment
- Cisplatin-ineligible participants defined by GFR below 60 mL/min, Grade 2 or higher hearing loss, Grade 2 or higher peripheral neuropathy, or NYHA Class III heart failure
- Experienced radiographic progression or relapse during or after first-line enfortumab vedotin plus pembrolizumab
- Participants who discontinued enfortumab vedotin plus pembrolizumab due to toxicity are eligible if disease progressed afterward
- Participants progressing during or within 12 months after neoadjuvant/adjuvant EV plus PD-1/PD-L1 inhibitors may be eligible with sponsor approval
You will not qualify if you...
- Prior systemic therapy for locally advanced or metastatic urothelial carcinoma other than EV plus pembrolizumab, except with sponsor approval
- History of allogeneic bone marrow or solid organ transplant
- Concomitant treatment with prohibited medications per protocol
- Prior TROP2-directed antibody-drug conjugate therapy
- Uncontrolled or significant cardiovascular disease including QTcF interval over 450 ms, recent myocardial infarction, uncontrolled angina, NYHA Class 3 or 4 heart failure, or uncontrolled hypertension
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids, current or suspected ILD/pneumonitis
- Clinically severe pulmonary compromise from pulmonary illnesses or autoimmune/connective tissue disorders with lung involvement
- Toxicities from previous anticancer therapy not improved to Grade 1 or baseline, except for stable Grade 2 toxicities managed with standard care
- Residual toxicities including anticancer therapy-induced neuropathy and certain endocrine disorders like hypothyroidism, hyperthyroidism, type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, or vitiligo
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 98 locations
1
Research Site
Fullerton, California, United States, 92835
Active, Not Recruiting
2
Research Site
Glendale, California, United States, 91204
Active, Not Recruiting
3
Research Site
La Jolla, California, United States, 92093
Active, Not Recruiting
4
Research Site
Orange, California, United States, 92868
Active, Not Recruiting
5
Research Site
San Francisco, California, United States, 94158
Active, Not Recruiting
6
Research Site
Aurora, Colorado, United States, 80012
Active, Not Recruiting
7
Research Site
Orange City, Florida, United States, 32763
Active, Not Recruiting
8
Research Site
St. Petersburg, Florida, United States, 33701
Active, Not Recruiting
9
Research Site
Tamarac, Florida, United States, 62269
Active, Not Recruiting
10
Research Site
Atlanta, Georgia, United States, 30342
Active, Not Recruiting
11
Research Site
Locust Grove, Georgia, United States, 30248
Active, Not Recruiting
12
Research Site
Effingham, Illinois, United States, 62401
Active, Not Recruiting
13
Research Site
Niles, Illinois, United States, 60714
Actively Recruiting
14
Research Site
Peoria, Illinois, United States, 61615
Actively Recruiting
15
Research Site
Largo, Maryland, United States, 20774
Active, Not Recruiting
16
Research Site
Boston, Massachusetts, United States, 02216
Active, Not Recruiting
17
Research Site
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
18
Research Site
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
19
Research Site
St Louis, Missouri, United States, 63110
Active, Not Recruiting
20
Research Site
New York, New York, United States, 10029
Active, Not Recruiting
21
Research Site
Chapel Hill, North Carolina, United States, 27514
Active, Not Recruiting
22
Research Site
Raleigh, North Carolina, United States, 27610
Active, Not Recruiting
23
Research Site
Portland, Oregon, United States, 97227
Active, Not Recruiting
24
Research Site
Monroeville, Pennsylvania, United States, 15146
Active, Not Recruiting
25
Research Site
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
26
Research Site
Providence, Rhode Island, United States, 02906
Active, Not Recruiting
27
Research Site
Myrtle Beach, South Carolina, United States, 29572
Active, Not Recruiting
28
Research Site
Germantown, Tennessee, United States, 38138
Active, Not Recruiting
29
Research Site
Memphis, Tennessee, United States, 38120
Active, Not Recruiting
30
Research Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
31
Research Site
Austin, Texas, United States, 33322
Active, Not Recruiting
32
Research Site
Dallas, Texas, United States, 75246
Actively Recruiting
33
Research Site
Dallas, Texas, United States, 75390
Active, Not Recruiting
34
Research Site
Charlottesville, Virginia, United States, 22908
Active, Not Recruiting
35
Research Site
Norfolk, Virginia, United States, 23502-1871
Actively Recruiting
36
Research Site
Spokane, Washington, United States, 99208
Active, Not Recruiting
37
Research Site
Madison, Wisconsin, United States, 53715
Active, Not Recruiting
38
Research Site
Graz, Austria, 8036
Active, Not Recruiting
39
Research Site
Krems, Austria
Active, Not Recruiting
40
Research Site
Linz, Austria, 4010
Active, Not Recruiting
41
Research Site
Salzburg, Austria, 5020
Active, Not Recruiting
42
Research Site
Vienna, Austria
Active, Not Recruiting
43
Research Site
Beijing, China, 100142
Actively Recruiting
44
Research Site
Chengdu, China
Active, Not Recruiting
45
Research Site
Guangzhou, China
Active, Not Recruiting
46
Research Site
Angers, France, 49055
Active, Not Recruiting
47
Research Site
Bordeaux, France, 33075
Actively Recruiting
48
Research Site
Brest, France
Actively Recruiting
49
Research Site
Calais, France
Active, Not Recruiting
50
Research Site
Cedex 10, France
Actively Recruiting
51
Research Site
Créteil, France
Actively Recruiting
52
Research Site
Grenoble, France
Active, Not Recruiting
53
Research Site
La Chaussée-Saint-Victor, France
Active, Not Recruiting
54
Research Site
La Roche-sur-Yon, France
Active, Not Recruiting
55
Research Site
Le Mans, France
Actively Recruiting
56
Research Site
Lyon, France
Actively Recruiting
57
Research Site
Marseille, France, 13273
Active, Not Recruiting
58
Research Site
Marseille, France
Active, Not Recruiting
59
Research Site
Montpellier, France
Actively Recruiting
60
Research Site
Nantes, France
Active, Not Recruiting
61
Research Site
Nîmes, France
Active, Not Recruiting
62
Research Site
Paris, France
Actively Recruiting
63
Research Site
Paris, France
Active, Not Recruiting
64
Research Site
Pierre-Bénite, France, 69310
Active, Not Recruiting
65
Research Site
Poitiers, France
Actively Recruiting
66
Research Site
Quint-Fonsegrives, France
Active, Not Recruiting
67
Research Site
Reims, France
Active, Not Recruiting
68
Research Site
Saint-Etienne, France
Actively Recruiting
69
Research Site
Saint-Herblain, France
Active, Not Recruiting
70
Research Site
Strasbourg, France, 67065
Active, Not Recruiting
71
Research Site
Toulouse, France
Active, Not Recruiting
72
Research Site
Vandœuvre-lès-Nancy, France
Actively Recruiting
73
Research Site
Eisleben Lutherstadt, Germany, 06295
Active, Not Recruiting
74
Research Site
Nürtingen, Germany
Actively Recruiting
75
Research Site
Stuttgart, Germany, 70174
Active, Not Recruiting
76
Research Site
Naples, Italy
Active, Not Recruiting
77
Research Site
Roma, Italy
Active, Not Recruiting
78
Research Site
Rozzano, Italy
Active, Not Recruiting
79
Research Site
Bunkyō City, Japan, 113-8519
Active, Not Recruiting
80
Research Site
Bunkyō City, Japan
Active, Not Recruiting
81
Research Site
Fukuoka, Japan, 812-8582
Active, Not Recruiting
82
Research Site
Fukuoka, Japan
Active, Not Recruiting
83
Research Site
Hirosaki-shi, Japan
Active, Not Recruiting
84
Research Site
Kanazawa, Japan
Active, Not Recruiting
85
Research Site
Kawasaki, Japan
Active, Not Recruiting
86
Research Site
Kōtoku, Japan, 135-8550
Active, Not Recruiting
87
Research Site
Kumamoto, Japan
Active, Not Recruiting
88
Research Site
Kyoto, Japan, 606-8507
Active, Not Recruiting
89
Research Site
Nagoya, Japan
Active, Not Recruiting
90
Research Site
Niigata, Japan
Active, Not Recruiting
91
Research Site
Okayama, Japan, 700-8558
Actively Recruiting
92
Research Site
Osaka, Japan
Actively Recruiting
93
Research Site
Osakasayama-shi, Japan, 589-8511
Active, Not Recruiting
94
Research Site
Sapporo, Japan
Active, Not Recruiting
95
Research Site
Shinjuku-ku, Japan
Active, Not Recruiting
96
Research Site
Toyama, Japan
Active, Not Recruiting
97
Research Site
Tsukuba, Japan, 305-8576
Active, Not Recruiting
98
Research Site
Ube-shi, Japan, 755-8505
Actively Recruiting
Research Team
C
Contact for Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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