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Androgen Receptor Inhibitor
Pembrolizumab + Olaparib for Metastatic Castration-resistant 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
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before screening
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to ~31 months
Awards & highlights
No Placebo-Only Group
Pivotal 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 Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have previously been treated with either abiraterone acetate or enzalutamide, but not both at the same time.
Select...
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.
Select...
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.
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 2021 Phase 3 trial • 453 Patients • NCT0306677854%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course
Awards & Highlights
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.
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 3
~2030
Olaparib
2017
Completed Phase 4
~1270
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,170 Total Patients Enrolled
6 Trials studying Prostate Cancer
15,103 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,822 Previous Clinical Trials
5,013,985 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,898 Patients Enrolled for Prostate Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,733 Previous Clinical Trials
8,016,233 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: Pembrolizumab + Olaparib
- Group 2: Next-generation Hormonal Agent Monotherapy (NHA)
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, 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."
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 colitise 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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