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Relacorilant + Pembrolizumab for Adrenocortical Cancer
Study Summary
This trial will study if a new drug combo is safe and effective for a particular type of 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 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- You have taken a certain type of medication before and it worked to improve your condition.You have brain metastases that have not been treated, or your central nervous system (CNS) metastases are not under control. You must be stable without needing steroids for at least 3 weeks before starting the study. If you have any neurological symptoms, you will need a CT or MRI scan to check for hidden CNS metastases.You are currently taking long-term steroid or other medication to treat an autoimmune disease.You need to use inhaled steroids, and there are no other treatment options if your condition gets worse during the study.You recently had treatment that caused severe side effects, and those side effects have not gone away completely.You have had another type of cancer in the past 3 years that is likely to come back, except for certain types like skin cancer or certain early-stage cancers that have been treated successfully.You have HIV, chronic or active hepatitis B, or chronic or active hepatitis C.You have been diagnosed with advanced ACC that cannot be removed with surgery.You have a disease that can be measured using specific guidelines set by the Investigator.You have too much cortisol in your body, as confirmed by medical records.If you have taken mitotane in the last 3 months, the level of mitotane in your body should be less than 4 mg/L when you are screened for the trial.You are able to perform daily activities with little or no help.Your organs and bone marrow work well, as shown by blood and urine tests.Women who can have babies must take a pregnancy test before the study and every 6 weeks to make sure they are not pregnant.You are taking a certain type of medication that can affect how other drugs work in your body.You have taken certain medications or treatments recently, or had a bad reaction to a specific type of medication.
- Group 1: Relacorilant in Combination with Pembrolizumab
- 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 results are researchers hoping to achieve from this clinical trial?
"This clinical trial will monitor a variety of endpoints over 24 months, starting from the date of first treatment until either disease progression or death. The primary objective is to observe Dose-Limiting Toxicity (DLT), while secondary outcomes include Non-Progression Rate (NPR) per RECIST v1.1, an evaluation of cortisol excess' effects on hypertension and diabetes mellitus, as well as Duration of Response (DOR)."
Has Relacorilant been sanctioned by the Food and Drug Administration?
"Our team at Power has determined that Relacorilant's safety rating is a 1, due to the limited data supporting its efficacy and level of harmlessness available from this Phase 1 clinical trial."
How many participants are engaging in this experiment?
"Affirmative. According to the clinicaltrials.gov database, this medical research is still actively seeking participants as of June 27th 2022; it was first posted on September 30th 2020. The trial requires 26 volunteers from 6 different cities/regions."
What is the geographic distribution of this experiment?
"There are 6 trial sites currently accepting participants, including Site #030 Mayo Clinic in Rochester, Site #150 Stanford Cancer Center in Stanford and Site#007 Moffitt Cancer Center in Tampa. Additionally, there are 3 other locations where the study is running."
Are there any registration opportunities still available for this trial?
"Affirmative. According to clinicaltrials.gov, this examination is actively recruiting patients as of June 27th 2022 - the last edit date for the trial post which was initially published on September 30th 2020. 6 sites are currently in need of 26 participants for the study."
What primary maladies is Relacorilant prescribed to address?
"Relacorilant is largely used to address malignant neoplasms, yet it also has potential applications for treating unresectable melanoma, microsatellite instability high, and chemotherapy-induced disease advancement."
Have other research initiatives explored the efficacy of Relacorilant?
"Relacorilant was initially documented in a research paper originating from the City of Hope during 2010. To this day, there are 260 completed studies and 963 trials still recruiting participants; many of these experiments take place at Rochester's medical facilities."
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