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Dato-DXd plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Previously Treated la/mUC.
EU CTIS ID: 2024-516906-47-00
What this study is testing
Phase 2: To evaluate the relative efficacy of Dato-DXd 4 mg/kg plus platinum therapy and Dato-DXd 6 mg/kg plus platinum therapy as measured by overall response rate (ORR) by investigator. Phase 3: To compare the efficacy of Dato-DXd plus platinum therapy with gemcitabine plus platinum therapy as measured by progression-free survival (PFS) by Blinded Independent Central Review (BICR). To compare the efficacy of Dato-DXd plus platinum therapy with gemcitabine plus platinum therapy as measured by overall survival (OS).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult ≥18 years at the time the ICF is signed.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra.
- Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing.
- Participant must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator’s judgment.
- Must have experienced radiographic progression or relapse during or after 1L of enfortumab vedotin (EV) and pembrolizumab. Participant who discontinued EV and pembrolizumab in 1L due to toxicity are eligible if they have experienced disease progression following discontinuation.
- Measurable disease on CT/MRI per RECIST version 1.1 as assessed by investigator.
You likely can't join if
- Has had prior systemic therapy other than the combination of EV and pembrolizumab for la/mUC.
- Has had treatment with any of the following: History of an allogeneic bone marrow or solid organ transplant, concomitant treatment with any prohibited medications in the protocol, prior TROP2 directed ADC therapy.
- Uncontrolled or significant cardiovascular disease.
- Has a 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.
- Has clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses.
- Has toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Participants may be enrolled with chronic, stable Grade 2 toxicities which the investigator deems related to previous anticancer therapy.
See the full eligibility criteria
- Adult ≥18 years at the time the ICF is signed.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra.
- Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing.
- Participant must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator’s judgment.
- Must have experienced radiographic progression or relapse during or after 1L of enfortumab vedotin (EV) and pembrolizumab. Participant who discontinued EV and pembrolizumab in 1L due to toxicity are eligible if they have experienced disease progression following discontinuation.
- Measurable disease on CT/MRI per RECIST version 1.1 as assessed by investigator.
- ECOG PS of 0 or 1.
- Has required baseline laboratory data: adequate bone marrow function, adequate renal function, adequate hepatic function, and adequate blood clotting function.
- Has had prior systemic therapy other than the combination of EV and pembrolizumab for la/mUC.
- Has had treatment with any of the following: History of an allogeneic bone marrow or solid organ transplant, concomitant treatment with any prohibited medications in the protocol, prior TROP2 directed ADC therapy.
- Uncontrolled or significant cardiovascular disease.
- Has a 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.
- Has clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses.
- Has toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Participants may be enrolled with chronic, stable Grade 2 toxicities which the investigator deems related to previous anticancer therapy.
- History of severe hypersensitivity to either the drug or inactive ingredients of Dato-DXd, platinum (i.e., both carboplatin and cisplatin), or gemcitabine.
- Has an uncontrolled infection requiring systemic therapy
- Has clinically significant corneal disease.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Argentina
- Australia
- Japan
- Brazil
- Taiwan
- China
- Canada
- Korea, Democratic People's Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Argentina; Australia; Japan; Brazil; Taiwan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.