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Androgen Receptor Inhibitor
Pembrolizumab + Olaparib for Prostate Cancer (KEYLYNK-010 Trial)
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~31 months
Awards & highlights
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.
Who is the study for?
Men with advanced prostate cancer that has spread and is resistant to hormone therapy. They must have previously been treated with abiraterone acetate or enzalutamide, but not both, and docetaxel chemotherapy without success. Participants need a testosterone level below 50 ng/dL and an ECOG performance status of 0 or 1.Check my eligibility
What is being tested?
The trial tests if combining pembrolizumab (an immunotherapy drug) with olaparib (a PARP inhibitor) is more effective than the standard treatments abiraterone acetate or enzalutamide in improving survival and slowing disease progression in metastatic castration-resistant prostate cancer.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, fatigue, nausea, blood-related issues like anemia, potential for infections due to lowered immunity, allergic reactions to medication components, and other individual-specific responses.
KEYLYNK-010 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~31 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Radiographic Progression-Free Survival (rPFS)
Secondary outcome measures
Duration of Response (DOR)
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience an Adverse Event (AE)
+6 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
KEYLYNK-010 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + OlaparibExperimental Treatment2 Interventions
Participants will receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
Group II: Next-generation Hormonal Agent Monotherapy (NHA)Active Control4 Interventions
Participants will receive a single NHA, which will be either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,490 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,290 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,095 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,306 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Next-generation Hormonal Agent Monotherapy (NHA)
- Group 2: Pembrolizumab + Olaparib
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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)."
Answered by AI
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, California."
Answered by AI
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 colitis, and high risk of recurrence."
Answered by AI
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