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Compares treatment options 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?
Dato-DXd is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urothelial cancer.
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 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.
- 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 locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) urothelial...
- Note 2: Participants with la/mUC and a history of nonclinically active prostate cancer are allowed into the trial if:
- Participant does not have radiological metastasis of a proven prostate cancer.
- Participant with nonmetastatic prostate cancer do not have rising PSA (as determined using local testing by a validated or approved test method)...
You likely can't join if
- Has had prior systemic therapy other than the combination of EV and pembrolizumab for la/mUC. The following participants may be considered eligible...
- Treatment with any of the following:
- 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:
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 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. Participants...
- Note 2: Participants with la/mUC and a history of nonclinically active prostate cancer are allowed into the trial if:
- Participant does not have radiological metastasis of a proven prostate cancer.
- Participant with nonmetastatic prostate cancer do not have rising PSA (as determined using local testing by a validated or approved test method) defined as follows:
- Increase in PSA within 2 consecutive measurements separated by at least 1 week (completed within 4 weeks prior to consent or within Screening) and neither of the measurements with an absolute value above 2 ng/mL.
- Participant does not currently receive androgen deprivation therapy for the treatment of prostate cancer.
- Note 3: Participant with MIBC (T2-T4aN0M0 or T1-T4aN1M0) who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1/PD-L1 inhibitors) as neoadjuvant/adjuvant therapy and progressed during...
- Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing. Tumor tissue sample should not be collected from a lesion that was irradiated unless...
- Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment. Participants eligible for cisplatin will receive cisplatin. If a participant received...
- GFR \<60 mL/min (GFR may be estimated by calculated CrCl using the Cockcroft-Gault formula, Modification of Diet in Renal Disease, or 24-hour urine) For Phase 2 part:
- Participants with a GFR \<60 mL/min but ≥50 mL/min but have no other cisplatin ineligibility criteria (items b, c, and d) may be considered cisplatin-eligible based on the investigator's clinical judgment. For Phase 3...
- 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. The dosing schedule and dose level for...
- 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). Participants who discontinued EV (or other...
- 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...
- Treatment with any of the following:
- 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.
- 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...
- Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2...
- Anticancer therapy-induced neuropathy
- Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies which may include:
- Hypothyroidism/ hyperthyroidism
- Type I diabetes
- Hyperglycemia
- Adrenal insufficiency
- Adrenalitis c. Skin hypopigmentation (vitiligo)
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
- Glendale, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Orange City, Florida, United States
- St. Petersburg, Florida, United States
- Tamarac, Florida, United States
- Atlanta, Georgia, United States
- Locust Grove, Georgia, United States
- Effingham, Illinois, United States
- Niles, Illinois, United States
- Peoria, Illinois, United States
- Largo, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
+ 75 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 - 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?
Study sites include Fullerton, California, United States; Glendale, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States and 89 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 ClinicalTrials.gov; the study team decides eligibility.