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Pembrolizumab + Olaparib for Metastatic Castration-resistant Prostate Cancer(KEYLYNK-010 Trial)
KEYLYNK-010 Trial Summary
This trial will study if a PARP inhibitor in combination with a immunotherapy drug is better than the current standard of care for men with metastatic prostate cancer who have failed to respond to either abiraterone acetate or enzalutamide.
KEYLYNK-010 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
KEYLYNK-010 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2021 Phase 3 trial • 453 Patients • NCT03066778
Awards & Highlights
KEYLYNK-010 Trial Design
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Who is running the clinical trial?
- You have a condition where your immune system attacks your own body and have needed medicine to treat it in the past two years.You have had a lung condition called pneumonitis in the past that needed treatment with steroids, or you currently have pneumonitis.You have already received radiation therapy or other radioactive treatment for prostate cancer in the past.You have already been treated with certain medications that target specific receptors on immune cells.You have cancer that has spread to the brain or covering of the brain (meninges).You have a history of seizures or any condition that makes you more likely to have seizures.You have fainted or lost consciousness within the past year.You have experienced severe allergic reactions to pembrolizumab or any of its ingredients.You have another type of cancer that has been getting worse or needed treatment in the past 3 years.You have already been treated with olaparib or any other medication like it called a PARP inhibitor.You have already been treated with apalutamide or darolutamide before.You have already been treated with enzalutamide or apalutamide for advanced prostate cancer that is sensitive to hormones.You have used herbal products that can affect prostate cancer or lower PSA levels before the study start date.You have previously been treated with either abiraterone acetate or enzalutamide, but not both at the same time.If you have received a medication called abiraterone acetate for advanced prostate cancer that has spread to other parts of the body, you should not have also taken abiraterone acetate or another medication called enzalutamide for a different stage of advanced prostate cancer.You have received a specific type of chemotherapy called docetaxel for advanced prostate cancer, but your cancer has continued to grow during or after this treatment.
- Group 1: Pembrolizumab + Olaparib
- Group 2: Next-generation Hormonal Agent Monotherapy (NHA)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Has Pembrolizumab completed the necessary steps for FDA approval?
"Pembrolizumab has undergone Phase 3 clinical trials, meaning that there is evidence of its efficacy and that it is safe."
Are there a few research sites near me that are testing this new treatment?
"There are 42 sites associated with this trial, with 3 major sites located in California, Utah, and Ohio. These are UCLA Hematology/Oncology - Santa Monica ( Site 0081), Huntsman Cancer Institute ( Site 0002), and The Urology Group- Cincinnati ( Site 0094) respectively."
Why was this research study conducted?
"The primary outcome of this clinical trial will be Overall Survival (OS), which will be measured over a period of up to 29 months. Secondary outcomes include the Objective Response Rate (ORR) as assessed by the Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Time to Pain Progression (TTPP) as assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3, and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score)."
Does Pembrolizumab have a long and extensive research history?
"Pembrolizumab was first trialled in 2001 at Hulston Cancer Center. In the 20 years since, there have been 1028 completed studies and 1587 active trials worldwide. A large portion of these active trials are based in Los Angeles, Californian Cancer Center. In the 20 years since, there have been 1028 completed studies and 1587 active trials worldwide. A large portion of these active trials are based in Los Angeles, California."
What autoimmune disease does Pembrolizumab commonly help to alleviate?
"Pembrolizumab is a treatment for unresectable melanoma, and can also be used to manage microsatellite instability high, ulcerative colitise melanoma, and can also be used to manage microsatellite instability high, ulcerative colitis, and high risk of recurrence."
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