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BMS-986416 + Nivolumab for Solid Tumors
Study Summary
This trial is testing a new drug, BMS-986416, to see if it is safe and effective when used alone or with another drug, nivolumab, to treat advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have serious heart problems that are not under control.I have a diagnosed connective tissue disorder like Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome.My cancer is advanced, cannot be surgically removed, has spread, or come back.My condition allows for repeated tissue sampling.There are other requirements for participation that will be explained in the study's guidelines.My cancer type is one of the specified: NSCLC, UC, SCCHN, HCC, MSS CRC, or PDAC.I need long-term blood thinners other than low-dose aspirin.My condition hasn't improved with standard treatments.
- Group 1: Part 1A: Monotherapy (BMS-986416)
- Group 2: Part 1B: Combination Therapy (BMS-986416 + 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
What indications have warranted the administration of BMS-986416?
"BMS-986416 is generally prescribed to address malignant tumors, but it can also be employed as a therapeutic approach for additional medical conditions such as metastatic esophageal adenocarcinoma and unresectable melanoma."
Is this a previously unexplored research endeavor?
"As of today, Ono Pharmaceutical Co. Ltd's BMS-986416 has 717 live trials being conducted in 2356 cities and 49 nations. Starting back in 2012 with 659 participants who went through Phase 1 & 2 approval stages, 252 additional studies have since been successfully completed."
How many participants is the research team recruiting for this clinical trial?
"Indeed, clinicaltrials.gov confirms that this study is presently enrolling 134 individuals from 20 different medical centres. The trial was initially posted on August 9th 2021 and the most recent update was November 28th 2022."
What prior research has been done concerning BMS-986416?
"Presently, there are 82 BMS-986416 trials in phase 3 and 717 studies ongoing. Basel, BE is the primary site for many of these tests; however, 40290 locations worldwide have clinical trials studying this medication."
What is the geographical scope of this clinical experiment?
"The experiment is currently enrolling patients from 20 different sites, including Madison, Toronto and Aurora. To reduce the burden of travel for participants it is advised to select a location that is proximate."
Has the FDA sanctioned BMS-986416 as a therapeutic course of action?
"The safety of BMS-986416 is assessed to be a 1 due its standing as a Phase 1 trial, thus providing limited evidence for both efficacy and safety."
Does this clinical trial currently have openings for participants?
"As confirmed by clinicaltrials.gov, this trial is still welcoming participants since it was initially listed on August 9th 2021 and updated November 28th 2022."
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