Olaparib for Melanoma, Uveal

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Moffitt Cancer Center, Tampa, FL
Melanoma, Uveal+3 More
Olaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination drug therapy for advanced uveal melanoma, a type of skin cancer. Olaparib is used to treat melanoma and uveal cancer. It has previously been approved by the FDA for another condition. However, in this trial, patients will not receive a placebo.

Eligible Conditions

  • Melanoma, Uveal
  • Ocular Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Melanoma, Uveal

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: up to 24 months

up to 24 months
Number of Adverse Events related to study treatment
Overall Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Melanoma, Uveal

Trial Design

1 Treatment Group

Pembrolizumab and Olaparib
1 of 1
Experimental Treatment

37 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Pembrolizumab and OlaparibExperimental Group · 2 Interventions: Olaparib, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2017
Completed Phase 4
~2060
Pembrolizumab
2017
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Closest Location: Moffitt Cancer Center · Tampa, FL
Photo of moffitt cancer center 1Photo of moffitt cancer center 2Photo of moffitt cancer center 3
2009First Recorded Clinical Trial
1 TrialsResearching Melanoma, Uveal
228 CompletedClinical Trials

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,631 Previous Clinical Trials
4,949,580 Total Patients Enrolled
3 Trials studying Melanoma, Uveal
546 Patients Enrolled for Melanoma, Uveal
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
487 Previous Clinical Trials
123,383 Total Patients Enrolled
1 Trials studying Melanoma, Uveal
16 Patients Enrolled for Melanoma, Uveal
Nikhil I Khushalani, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
112 Total Patients Enrolled
1 Trials studying Melanoma, Uveal
16 Patients Enrolled for Melanoma, Uveal

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Male participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 200 days after the last dose of study treatment and refrain from donating sperm during this period.
You provide informed consent for the trial.
You have measurable disease based on RECIST 1.1.49 Lesions situated in a previously irradiated area.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
You have the ability to swallow oral medications.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.