DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers (NCT04388852) | Clinical Trial Compass
Active — Not RecruitingPhase 1
DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers
United States65 participantsStarted 2020-08-20
Plain-language summary
This phase Ib trial studies the side effects and best dose of DS3201 when given together with and ipilimumab for the treatment of patients with prostate, urothelial, or renal cell cancer that has spread to other places in the body (metastatic). DS3201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving DS3201 and ipilimumab may help to control the disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Histologically or cytologically confirmed prostate carcinomas, urothelial carcinomas and clear cell renal carcinomas. For patients with prostate carcinomas, variant histologies, such as small cell or neuroendocrine carcinomas are permitted
* Evidence of metastatic disease by conventional imaging studies (computed tomography \[CT\], magnetic resonance imaging \[MRI\] and/or bone scan). Patients with locally advanced disease that is not amenable to locoregional therapies such as surgery or radiation, are considered metastatic and eligible to participate
* Patients with prostate carcinomas must have castration resistant disease, i.e. evidence of disease progression while having castrate levels of testosterone (=\< 50 ng/dL or =\< 2.0 nM) or an unsatisfactory response to \>= 1 month of castration, as defined by lack of symptom control and/or serum tumor marker response of \< 20% (confirmed by a second value drawn on a different day). Exception: patients with small cell carcinoma histology are not required to have progressed during prior androgen deprivation therapy. However, all patients with prostate cancer (including those with small cell carcinomas) are required to maintain castrate levels of testosterone throughout the duration of the study
* Patients with prostate carcinomas must also display the AVPC molecular signature (i.e. known loss or mutation \[by Clinical Laboratory Improvement …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: Up to 60 days after last valemetostat dose and 100 days after last ipilimumab dose