Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05524935
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ocular Melanoma
  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab Day 1 of each 21 day (3 week) cycle
  • Olaparib — DRUG
    Olaparib by mouth days 1-21 of each 21 day (3 week) cycle

Study Details

This is a prospective phase II multi-center trial of the combination of the PARP inhibitor olaparib with the immune checkpoint inhibitor pembrolizumab in advanced uveal melanoma.

Key Dates

Start date
Oct 11, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab and Olaparib
    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

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Nikhil I Khushalani, MD (PRINCIPAL_INVESTIGATOR)
Andrew Brohl, MD (SUB_INVESTIGATOR)
Zeynep Eroglu, MD (SUB_INVESTIGATOR)
Joseph Markowitz, MD, PhD (SUB_INVESTIGATOR)
Jane Messina, MD (SUB_INVESTIGATOR)
Keiran Smalley, PhD (SUB_INVESTIGATOR)
Ahmad Tarhini, MD, PhD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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