Trial comparing treatments for Urothelial Cancer
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
ClinicalTrials.gov ID: NCT07129993
What this study is testing
What is Dato-DXd?
This is an investigational medicine being studied as a potential treatment for urothelial cancer. It is designed to attach to specific targets on cancer cells and deliver a chemotherapy drug directly into them to help stop their growth.
Also referred to as Datopotamab Deruxtecan.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether datopotamab deruxtecan plus carboplatin or cisplatin works better than gemcitabine plus carboplatin or cisplatin in people with advanced bladder cancer who have already had other medicines.
- Who it's for
- You may be able to join if you have advanced bladder cancer that got worse after receiving enfortumab vedotin and pembrolizumab.
- What's involved
- You would receive either datopotamab deruxtecan with carboplatin or cisplatin, or gemcitabine with carboplatin or cisplatin. You will have regular doctor visits and tests to check how you feel.
- Time commitment
- The study lasts several months with visits at the start, during treatment, and later check‑ins.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult ≥18 years at the time the ICF is signed (if the legal age of consent is \> 18 years old, then follow the local regulatory requirements).
- Histologically or cytologically confirmed unresectable or locally advanced (T4b, any N
- Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing.
- Archival tissue collected after the most recent anticancer treatment and within 12 months before the informed consent date is preferred.
- Participants with borderline renal function CrCl ≥40 mL/min to \<60 mL/min who have no other cisplatin ineligibility criteria (items b, c, and d) may...
You likely can't join if
- Has had prior systemic therapy other than the combination of EV and pembrolizumab for la/mUC.
- Participant who progressed during or after treatments with assets that include either anti-Nectin 4 or vedotin payload (MMAE or other microtubule...
- History of an allogeneic bone marrow or solid organ transplant.
- Concomitant treatment with any prohibited medications in this protocol.
- Prior TROP2 directed ADC therapy.
- Uncontrolled or significant cardiovascular disease, including: QTcF interval \>470 ms based on the average of triplicate 12-lead (ECG per local read)...
See the full eligibility criteria
- Adult ≥18 years at the time the ICF is signed (if the legal age of consent is \> 18 years old, then follow the local regulatory requirements).
- Histologically or cytologically confirmed unresectable or locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) 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.
- Archival tissue collected after the most recent anticancer treatment and within 12 months before the informed consent date is preferred.
- Participants with borderline renal function CrCl ≥40 mL/min to \<60 mL/min who have no other cisplatin ineligibility criteria (items b, c, and d) may receive cisplatin using a split-dose regimen, administered as...
- In participants with CrCl ≥50 mL/min to \<60 mL/min, full-dose cisplatin may also be administered at the investigator's discretion, based on the overall clinical assessment.
- 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).
- 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.
- Participant 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.
- History of an allogeneic bone marrow or solid organ transplant.
- Concomitant treatment with any prohibited medications in this protocol.
- Prior TROP2 directed ADC therapy.
- Uncontrolled or significant cardiovascular disease, including: QTcF interval \>470 ms based on the average of triplicate 12-lead (ECG per local read) at screening.
- Screening myocardial infarction within 6 months prior to randomization.
- Uncontrolled angina pectoris within 6 months prior to randomization.
- NYHA Class 3 or 4 congestive heart failure at screening.
- Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).
- 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 including, but not limited to, any underlying pulmonary disorder (eg, severe asthma, severe...
- Hypothyroidism/ hyperthyroidism
- Type I diabetes
- Hyperglycemia
- Adrenal insufficiency
- Adrenalitis c. Skin hypopigmentation (vitiligo)
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Niles, Illinois, United States
- Peoria, Illinois, United States
- Grand Rapids, Michigan, United States
- Chapel Hill, North Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Norfolk, Virginia, United States
- Beijing, China
- Bordeaux, France
- Brest, France
- Cedex 10, France
- Créteil, France
- La Roche-sur-Yon, France
- Le Mans, France
- Lyon, France
- Montpellier, France
- Paris, France
- Poitiers, France
- Saint-Etienne, France
+ 9 more site(s).
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Niles, Illinois, United States; Peoria, Illinois, United States; Grand Rapids, Michigan, United States; Chapel Hill, North Carolina, United States; Nashville, Tennessee, United States and 23 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.