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BMS-986218 + Nivolumab + Docetaxel for Prostate Cancer
Study Summary
This trial is testing 3 different combinations of drugs to see which is most effective at treating men with metastatic prostate cancer that has progressed after other treatments.
- Castration-resistant Prostate Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729Trial Design
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Who is running the clinical trial?
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- You have another type of cancer that requires treatment or you have had cancer within the past two years.There are other requirements and restrictions for being part of this study that will be explained to you.
- Group 1: Arm 1A: Docetaxel + BMS-986218
- Group 2: Arm 2C: Docetaxel + BMS-986218 + Nivolumab
- Group 3: Arm 2B: Docetaxel + BMS-986218
- Group 4: Arm 1B: Docetaxel + BMS-986218 + Nivolumab
- Group 5: Arm 2A: Docetaxel
- Group 6: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are enrolled in this trial?
"This medical trial requires 204 voluntary participants that qualify for the inclusion criteria. Intending volunteers can take part from various sites, such as University of Texas MD Anderson Cancer Center in Columbia, Maryland and Willamette Valley Cancer Institute And Research Center in Tampa, Florida."
How is the medication Docetaxel most commonly utilized?
"Docetaxel is predominantly employed to address cancerous neoplasms, but can also be utilized for treating a multitude of other illnesses such as unresectable melanoma, squamous cell carcinoma and sarcoma."
What is the ultimate objective of this research endeavor?
"This trial, which entails a 4 year period of observation and monitoring, aims to measure the frequency of adverse events (AEs). Secondary objectives include measuring AEs leading to discontinuation as classified in Part 2, duration of response per Prostate cancer Working Group 3 (DOR-PCWG3) as stipulated in Part 2, and death rate according to Part 2."
Has the FDA sanctioned Docetaxel for therapeutic applications?
"There is some evidence of the safety profile for Docetaxel, so it has been assigned a score of 2. In this Phase 2 clinical trial, efficacy data remains absent."
How many centers are currently conducting this research project?
"Across the United States, 33 clinical trial sites are recruiting patients to participate in this research. Prominent locations include University of Texas MD Anderson Cancer Center (Columbia), Willamette Valley Cancer Institute and Research Centre (Tampa), and Texas Oncology (Marietta)."
Have prior experiments been conducted using Docetaxel?
"Currently, there are 1,016 clinical trials studying the effects of Docetaxel. Specifically, 201 live studies in Phase 3 have been documented with 61190 locations running experiments on this drug located predominantly in Fuzhou, Fujian."
Is there availability for prospective participants in this experiment?
"As per clinicaltrials.gov, this trial is recruiting participants as of now. The listing was initially posted on February 14th 2022 and changed most recently on August 1st 2022."
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