Datopotamab Deruxtecan + Platinum-Based Therapy for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with advanced bladder cancer who did not respond to previous treatments. The study compares a new drug combination, including Datopotamab Deruxtecan (an experimental treatment) and standard platinum-based chemotherapy (such as carboplatin or cisplatin), against usual chemotherapy treatments. It aims to determine which approach is more effective and safer for patients. Suitable candidates have advanced urothelial carcinoma that returned or worsened after a specific previous treatment combination. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to explore new options.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it mentions that certain medications are prohibited. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that Datopotamab Deruxtecan (Dato-DXd) yields promising results in treating various cancers, including bladder cancer. Research suggests that this treatment can be effective, with some patients experiencing a noticeable reduction in tumor size. Previous trials have not identified any unexpected safety issues, indicating that the treatment is generally well-tolerated.
It is important to understand that this clinical trial remains in its early stages, and researchers continue to gather detailed safety information. The trial's progression to this stage suggests some confidence in the treatment's safety based on earlier studies. Participants in clinical trials are closely monitored to ensure their safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Datopotamab Deruxtecan (Dato-DXd) for bladder cancer because it introduces a novel approach by combining an antibody-drug conjugate with platinum-based chemotherapy. Unlike traditional chemotherapy that broadly attacks rapidly dividing cells, Dato-DXd specifically targets and delivers chemotherapy directly to cancer cells, potentially increasing its effectiveness and minimizing damage to healthy cells. This targeted mechanism might lead to better outcomes and fewer side effects compared to the standard treatments like Gemcitabine with Carboplatin or Cisplatin. Additionally, the trial explores varying doses of Dato-DXd to determine the optimal regimen, which could refine and enhance treatment protocols for future patients.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
In this trial, participants will receive different treatment combinations to evaluate their effectiveness for advanced bladder cancer. Research has shown that datopotamab deruxtecan, one of the treatments tested in this trial, shows promise when combined with platinum-based treatments like carboplatin or cisplatin. Specifically, earlier studies indicated that patients receiving datopotamab deruxtecan experienced a median progression-free survival of 6.9 months, meaning their cancer did not worsen for nearly 7 months on average. Additionally, this combination effectively shrank or controlled tumors in many patients. These findings suggest that this treatment could benefit those whose cancer has worsened after previous treatments.34567
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced or metastatic urothelial carcinoma, predominantly transitional cell type. Participants must have progressed after EV and pembrolizumab treatment, not have prostate cancer metastasis or high PSA levels, and cannot be on androgen deprivation therapy. They need to provide a tumor tissue sample and have a GFR of at least 50 mL/min.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 2 Treatment
Participants receive Dato-DXd plus carboplatin or cisplatin to assess preliminary efficacy and safety, and determine the recommended Phase 3 dose (RP3D)
Phase 3 Treatment
Participants receive either Dato-DXd at the RP3D or gemcitabine plus carboplatin or cisplatin to evaluate progression-free survival and overall survival
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Datopotamab Deruxtecan
- Gemcitabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology