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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 or female participants who are at least 18 years of age with histologically confirmed diagnosis of metastatic uveal melanoma
Prior hepatic directed therapy for metastatic uveal melanoma is permitted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

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 below
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I am 18 or older with a confirmed diagnosis of metastatic uveal melanoma.
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I have had liver treatment for eye melanoma that has spread.
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I agree to use birth control and not donate sperm during the study.
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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.
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I can take pills by mouth.
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My organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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 • NCT02184195
49%
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%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
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%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
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%
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%
General physical health deterioration
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2070
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
535 Previous Clinical Trials
134,521 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,845 Previous Clinical Trials
5,045,912 Total Patients Enrolled
Nikhil I Khushalani, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
112 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05524935 — Phase 2
Uveal Melanoma Research Study Groups: Pembrolizumab and Olaparib
Uveal Melanoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT05524935 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05524935 — Phase 2

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
~13 spots leftby Dec 2024