BridgeMD
Compares treatment options for High-risk Muscle Invasive Urothelial Carcinoma
Official title An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
ClinicalTrials.gov ID: NCT07720284
What this study is testing
What is Dato-DXd?
Dato-DXd is an investigational medicine, being studied as a potential treatment for high-risk muscle invasive urothelial carcinoma.
Also referred to as Datopotamab deruxtecan, (Dato-DXd, DS-1062a).
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
- Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection. Study details: Duration: \~78 months (6.5 years) from FSI to last subject visit Treatment length: up to \~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3
- 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
- Participant must be \> 18 years of age at the time of signing the ICF.
- Histologically confirmed MIUC of the bladder or upper tract.
- Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease.
- Pathologic evidence of urothelial carcinoma at high-risk of recurrence and
- not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage
You likely can't join if
- Any tumour with predominant or pure high grade neuroendocrine carcinoma component.
- Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy.
- Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma.
- Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social...
- History of clinically significant corneal disease.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first...
See the full eligibility criteria
- Participant must be \> 18 years of age at the time of signing the ICF.
- Histologically confirmed MIUC of the bladder or upper tract.
- Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease.
- Pathologic evidence of urothelial carcinoma at high-risk of recurrence and
- not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage
- completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage
- No evidence of disease at screening,
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
- Minimum life expectancy of \> 12 weeks at time of screening.
- An archival surgical tumour sample must be available pre-randomisation for central testing.
- Adequate organ and bone marrow function within 28 days before randomisation.
- Any tumour with predominant or pure high grade neuroendocrine carcinoma component.
- Partial cystectomy in the setting of bladder cancer primary tumour or partial nephrectomy.
- Any adjuvant systemic or radiation therapy post-surgery for urothelial carcinoma.
- Severe or uncontrolled systemic diseases, history of organ transplant or allogeneic stem cell transplant, or psychological disorders/social situations, and/or substance abuse.
- History of clinically significant corneal disease.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention and of low potential risk for recurrence.
- Ongoing toxicities except alopecia from prior cancer treatment must be Grade ≤ 1 or at baseline. Stable Grade 2 toxicities are allowed if unchanged for ≥3 months and managed by standard care.
- Active or uncontrolled hepatitis B or C virus infection.
- Known HIV infection that is not well controlled.
- Any other active or uncontrolled infection including tuberculosis requiring systemic treatment that has not resolved by the time of randomisation.
- 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 function compromise.
- Mean resting corrected QTcF \> 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening
- Uncontrolled or significant cardiac conditions.
- Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment in the past 5 years.
- Prior exposure to TROP2-directed therapies, other ADCs with deruxtecan, therapeutic anti-cancer vaccines, anti-TIGIT therapy or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms.
- Current or prior use of immunosuppressive medication within 14 days prior to treatment assignment/randomisation.
- Known history of severe hypersensitivity reactions to any study drug
- Not eligible to receive at least one of SoC according to local regulations/approvals.
- Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Hot Springs, Arkansas, United States
- Little Rock, Arkansas, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- Albany, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Falls Church, Virginia, United States
- Seattle, Washington, United States
- Tacoma, Washington, United States
- Milwaukee, Wisconsin, United States
- Auchenflower, Australia
- Ballarat, Australia
+ 116 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 Hot Springs, Arkansas, United States; Little Rock, Arkansas, United States; San Francisco, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Kansas City, Missouri, United States and 130 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.