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PARP Inhibitor
Olaparib + Pembrolizumab for Eye Melanoma
Phase 2
Recruiting
Led By Nikhil I Khushalani, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male participants must agree to use contraception during the treatment period and refrain from donating sperm
Male or female participants who are at least 18 years of age with histologically confirmed diagnosis of metastatic uveal melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new combination drug therapy for advanced uveal melanoma, a type of skin cancer.
Who is the study for?
Adults with confirmed metastatic uveal melanoma can join this trial if they're not pregnant, breastfeeding, or planning to conceive. They must be able to take oral meds and have good organ function. Prior treatments for eye melanoma are okay, but no recent cancer therapies or live vaccines, and no history of certain diseases like active hepatitis or tuberculosis.Check my eligibility
What is being tested?
The study is testing a combination of two drugs: Olaparib (a PARP inhibitor) and Pembrolizumab (an immune checkpoint inhibitor), in patients with advanced eye melanoma. It's a phase II trial to see how well these drugs work together against this type of cancer.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs, fatigue, nausea, blood cell changes increasing infection risk. Specific side effects from each drug may vary; Olaparib might cause digestive issues while Pembrolizumab could lead to skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control and not donate sperm during the study.
Select...
I am 18 or older with a confirmed diagnosis of metastatic uveal melanoma.
Select...
I am not pregnant or breastfeeding and follow the required contraceptive guidelines.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Number of Adverse Events related to study treatment
Overall Survival (OS)
Progression Free Survival (PFS)
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and OlaparibExperimental Treatment2 Interventions
Participants will be given 200 mg Pembrolizumab IV every 21 days + will take 300 mg Olaparib by mouth twice daily days 1-21 of each 21 day cycle. Treatment will continue until progression, unacceptable toxicity, or for a maximum of 35 treatment cycles
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?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,445 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,634 Total Patients Enrolled
Nikhil I Khushalani, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
112 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take pills by mouth.My organs are functioning well.You have a specific amount of disease that can be measured using a standard guideline.I agree to use birth control and not donate sperm during the study.I have had pneumonitis treated with steroids or currently have it.I have received a transplant from another person.I have not received a live vaccine in the last 30 days.I have been diagnosed with HIV.I have previously been treated with PARP inhibitors.I have another cancer that is getting worse or needs treatment.I have an active case of tuberculosis.I am 18 or older with a confirmed diagnosis of metastatic uveal melanoma.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have had liver treatment for eye melanoma that has spread.I had radiotherapy less than 2 weeks before starting the study treatment.I don't have any health issues that could affect the study's results.I have been treated for an autoimmune disease in the last 2 years.I am a woman who can have children and I tested positive for pregnancy recently.I was treated with specific immune therapy for eye melanoma in the last 2 years.I am currently on medication for an infection.I have an active Hepatitis B or C infection.I have an immune system disorder or I'm on long-term steroids.I have active brain metastases or cancer in the lining of my brain.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab and Olaparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any life-threatening risks associated with Olaparib?
"While there is some data supporting Olaparib's safety, it remains unproven whether or not the drug is effective. Consequently, it received a score of 2."
Answered by AI
How many individuals are being helped by this lenalidomide study?
"The information available on clinicaltrials.gov suggests that this research study is still recruiting patients. This trial was first posted on October 5th, 2020 and has not been updated since then. 37 individuals are needed for the research to be conducted at 1 location."
Answered by AI
Are people still being accepted into this trial?
"That is correct, the clinical trial mentioned is currently looking for patients. This information can be found on clinicaltrials.gov. The first posting was on 10/5/2022 and the last update was also on that date. They are searching for 37 patients from 1 location."
Answered by AI
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