OncoMatch/Clinical Trials/NCT07129993
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Is NCT07129993 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2/3 trial studies multiple treatments including Dato-DXd and Carboplatin for urothelial cancer.
Treatment: Dato-DXd · Carboplatin · Cisplatin · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage T4B, ANY N, ANY T, N2-3, ANY T, ANY N, M1
unresectable or locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) urothelial carcinoma
Prior therapy
Must have received: systemic therapy (EV plus pembrolizumab or other vedotin payload plus PD-1/PD-L1 inhibitor) (enfortumab vedotin, pembrolizumab) — locally advanced or metastatic urothelial carcinoma
Must have experienced radiographic progression or relapse during or after 1L of EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1/PD-L1 inhibitors).
Cannot have received: systemic therapy other than EV plus pembrolizumab for la/mUC
Exception: Participants who progressed during or after treatments with assets that include either anti-Nectin 4 or vedotin payload (MMAE or other microtubule inhibitors) combined with PD1/PD-L1 inhibitors in 1L la/mUC may be eligible after approval by the Sponsor's Medical Monitor or designee.
Has had prior systemic therapy other than the combination of EV and pembrolizumab for la/mUC. The following participants may be considered eligible after approval by the Sponsor's Medical Monitor or Sponsor's designee.
Cannot have received: TROP2 directed antibody-drug conjugate therapy
Prior TROP2 directed ADC therapy
Lab requirements
Kidney function
cisplatin-ineligible if GFR <60 mL/min (may be eligible for carboplatin); for phase 2: GFR <60 but ≥50 mL/min may be considered cisplatin-eligible at investigator's discretion; for phase 3: CrCl ≥40 mL/min to <60 mL/min may receive split-dose cisplatin; CrCl ≥50 mL/min to <60 mL/min may receive full-dose cisplatin at investigator's discretion
Cardiac function
NYHA Class III or IV heart failure is a cisplatin ineligibility criterion and an exclusion criterion; uncontrolled or significant cardiovascular disease (QTcF >470 ms, recent MI, uncontrolled angina, uncontrolled hypertension)
Participants are cisplatin-ineligible if they meet any of the following criteria: a. GFR <60 mL/min ... b. NCI-CTCAE Grade ≥2 audiometric hearing loss c. NCI-CTCAE Grade ≥2 peripheral neuropathy d. NYHA Class III heart failure ... Uncontrolled or significant cardiovascular disease, including: QTcF interval >470 ms ... myocardial infarction within 6 months ... uncontrolled angina ... NYHA Class 3 or 4 congestive heart failure ... uncontrolled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Fullerton, California
- Research Site · Glendale, California
- Research Site · La Jolla, California
- Research Site · Los Angeles, California
- Research Site · Orange, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07129993 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy other than EV plus pembrolizumab for la/mUC, TROP2 directed antibody-drug conjugate therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage T4B, ANY N or ANY T, N2-3 or ANY T, ANY N, M1 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages