Actively Recruiting
Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
37
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with histologically confirmed metastatic uveal melanoma
- Prior liver-directed therapy for metastatic uveal melanoma is allowed
- Male participants must agree to use contraception during treatment and for 200 days after last dose and avoid sperm donation during this time
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during treatment and for 120 days after last dose
- Written informed consent must be provided
- Measurable disease based on RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to swallow oral medications (olaparib)
- Adequate organ function as defined in the protocol
You will not qualify if you...
- Positive pregnancy test within 72 hours before starting study therapy for women of childbearing potential
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents for uveal melanoma
- Prior PARP inhibitor therapy
- Systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment
- Radiotherapy within 2 weeks before study intervention unless recovery and no corticosteroids needed
- Live vaccine within 30 days before first dose of study drug
- Immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days before first dose
- Active progressing malignancy requiring treatment
- Active CNS metastases or carcinomatous meningitis unless stable and on low-dose corticosteroids
- Severe hypersensitivity to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of pneumonitis requiring steroids or current pneumonitis
- Active infection needing systemic therapy
- Known HIV infection
- Active Hepatitis B or C infection
- Active tuberculosis
- Conditions or abnormalities interfering with study participation
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or planning conception/fathering during study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
M
Maureen Canelo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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