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DKY709 + PDR001 for Cancer
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective.
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 am fully active and can carry on all my pre-disease activities without restriction.For the additional part of the study, patients must have one of the following: non-small cell lung cancer with a history of PD-L1 levels of at least 1% and disease progression after at least 4 months of stable or improved condition with previous anti-PD-L1 treatment; previously treated cutaneous melanoma with documented disease progression after anti-PD-1/PD-L1 therapy; nasopharyngeal carcinoma (NPC) without prior anti-PD-1/PD-L1 therapy; microsatellite stable colorectal cancer (mssCRC) without prior anti-PD-1/PD-L1 therapy; triple-negative breast cancer (TNBC) without prior anti-PD-1/PD-L1 therapy.I do not have serious heart problems or recent heart attacks.My advanced cancer has worsened after standard treatment, or I can't tolerate it, and no other standard treatments work for me.I have NSCLC or melanoma treated with anti-PD-1/PD-L1 therapy, or I have NPC.You have a measurable disease according to specific guidelines.Your kidney function, liver function, and blood cell counts need to be within certain ranges to qualify for the study.I am 18 years old or older.I have brain metastases that are stable, and I haven't taken steroids for 2 weeks.You have had a serious allergic reaction to any part of the study drug or similar medications.I am willing and able to have a biopsy of my cancer as per my hospital's rules.
- Group 1: DKY709 + PDR001
- Group 2: DKY709
- 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 risks, if any, are associated with PDR001?
"As PDR001 is currently in its initial clinical trial, the safety score assigned to this medication was a 1. This indicates that there are only limited data supporting both efficacy and security."
Is this experiment a pioneering endeavor in its field?
"Since its inception in 2011, PDR001 has been subject to many trials. The initial study was sponsored by Novartis Pharmaceuticals and yielded 185 participants. Subsequently the drug received approval for Phase 1 in 2011 and currently there are 27 active studies occurring across 122 urban areas and 35 nations."
How many participants are presently being treated with this experimental protocol?
"Affirmative. The clinicaltrials.gov website supports the fact that this medical investigation is actively recruiting volunteers - it was first announced on May 7th 2019 and most recently updated on 26th of May 2022. This trial requires 380 participants to be recruited from three sites in total."
Is there any existing research exploring the effects of PDR001?
"PDR001 was initially investigated by the UCLA School of Medicine in 2011. There have been 21 concluded studies and there are currently 27 trials still ongoing, with a substantial amount of these being conducted out of Nashville, Tennessee."
Are there any new participants currently being accepted for this research project?
"Affirmative. According to the information hosted on clinicaltrials.gov, this research is actively seeking volunteers since it was initially announced on May 7th 2019 and last modified on May 26th 2022. 380 participants are needed for the study at 3 distinct sites."
What is the end goal of this investigation?
"This 1 month clinical trial intends to assess the tolerability of DKY709 as a single agent or in combination with PDR001. The secondary objectives include determining the best overall response and measuring the area under curve (AUC) and maximum concentration (Cmax) of both drugs being tested."
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