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PARP Inhibitor

Olaparib + Pembrolizumab for Eye Melanoma

Tampa, FL

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

Must not have

History of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Had an allogenic tissue/solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination drug therapy for advanced uveal melanoma, a type of skin cancer.

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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 agree to use birth control and not donate sperm during the study.

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I am 18 or older with a confirmed diagnosis of metastatic uveal melanoma.

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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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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or currently have it.

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I have received a transplant from another person.

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I have been diagnosed with HIV.

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I have previously been treated with PARP inhibitors.

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I have another cancer that is getting worse or needs treatment.

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I have an active case of tuberculosis.

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I have been treated for an autoimmune disease in the last 2 years.

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I am a woman who can have children and I tested positive for pregnancy recently.

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I was treated with specific immune therapy for eye melanoma in the last 2 years.

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I am currently on medication for an infection.

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I have an active Hepatitis B or C infection.

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I have an immune system disorder or I'm on long-term steroids.

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I have active brain metastases or cancer in the lining of my brain.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

Number of Adverse Events related to study treatment

Overall Survival (OS)

Progression Free Survival (PFS)

Side effects data

From 2022 Phase 4 trial • 202 Patients • NCT04330040

51%

Anaemia

22%

Thrombocytopenia

20%

Nausea

17%

Vomiting

16%

Fatigue

11%

Leukopenia

11%

Diarrhoea

11%

Decreased appetite

10%

Pyrexia

10%

Back pain

Abdominal pain

Neutropenia

Asthenia

Constipation

Headache

Cough

Dyspnoea

COVID-19

Malaria

Pericardial effusion

Abdominal pain upper

Death

Dengue fever

Ischaemic stroke

Vaginal discharge

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Ovarian Cancer

Breast Cancer

Both Ovarian Cancer and Breast Cancer

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

~2630

Olaparib

2017

Completed Phase 4

~2310