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PARP Inhibitor

Olaparib + Pembrolizumab for Melanoma

Phase 2
Recruiting
Led By Kevin B Kim, MD
Research Sponsored by California Pacific Medical Center Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have genetic HR mutation/ alteration including ARID1A/B, ARID2, ATM, ATR, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCA, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B
Disease must be refractory or resistant to anti PD-1 therapy (defined as disease progression within 6 months after the last dose of anti PD-1 antibody therapy) and, for V600 BRAF mutation, disease must be progressed after BRAF inhibitor therapy; or patients could not have tolerated the standard therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Study Summary

This trial is testing a combination of drugs to treat patients with advanced melanoma that has progressed despite other treatments. Olaparib may stop the growth of tumor cells, and pembrolizumab may help the immune system attack the tumor. The trial will assess the safety and effectiveness of the combination.

Who is the study for?
This trial is for adults with advanced melanoma that can't be removed by surgery or has spread, and have specific gene changes called HR mutations. They must have tried immunotherapy and, if they have a BRAF mutation, also BRAF inhibitors without success or couldn't tolerate them. Participants need to be fairly healthy overall and not on high-dose steroids.Check my eligibility
What is being tested?
The study tests the combination of Olaparib, which blocks enzymes helping tumor growth, with Pembrolizumab, an immune system booster against cancer. It's for patients whose melanoma worsened after previous treatments. The goal is to see how effective and safe this drug combo is in these cases.See study design
What are the potential side effects?
Olaparib may cause nausea, vomiting, fatigue, anemia (low red blood cells), and more serious issues like lung problems or blood clots. Pembrolizumab might lead to flu-like symptoms, skin reactions, organ inflammation but could also result in severe immune system attacks on organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific genetic mutation.
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My cancer did not respond or stopped responding to PD-1 inhibitors, and if it has the BRAF mutation, it also did not respond to BRAF inhibitors or I couldn't tolerate the treatment.
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I have had only one chemotherapy treatment but may have had multiple immunotherapy or targeted therapy treatments.
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My melanoma cannot be removed by surgery and is in stage III or IV.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have recovered from side effects of previous treatments to my normal or mild condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Overall survival (OS)
Progression-free survival (PFS)

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Olaparib + PembrolizumabExperimental Treatment2 Interventions
This arm will enroll patients who has advanced melanoma with a genetic HR mutation/ alteration including mutation/ deletion in ARID1A/B, ARID2, ATM, ATR, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCA, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

California Pacific Medical Center Research InstituteLead Sponsor
43 Previous Clinical Trials
12,485 Total Patients Enrolled
5 Trials studying Melanoma
117 Patients Enrolled for Melanoma
M.D. Anderson Cancer CenterOTHER
2,944 Previous Clinical Trials
1,775,340 Total Patients Enrolled
102 Trials studying Melanoma
25,305 Patients Enrolled for Melanoma
Kevin B Kim, MDPrincipal InvestigatorCalifornia Pacific Medical Center Research Institute
3 Previous Clinical Trials
125 Total Patients Enrolled
3 Trials studying Melanoma
125 Patients Enrolled for Melanoma

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04633902 — Phase 2
Melanoma Research Study Groups: Olaparib + Pembrolizumab
Melanoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04633902 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04633902 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Olaparib been trialed in other medical experiments?

"As of this moment, 1114 clinical trials for Olaparib are in operation. Of these studies, 143 have progressed to the third stage of development. Though the majority is based in Houston, Texas there are 42747 sites where research about this medication is being conducted."

Answered by AI

What indications is Olaparib typically recommended for?

"Olaparib is primarily prescribed to treat unresectable melanoma, but has been known to be effective in the management of microsatellite instability high and cases with a heightened risk of relapse."

Answered by AI

Is this a fresh endeavor in medical trials?

"Olaparib has been the subject of clinical research since 2005 when AstraZeneca completed their first trial involving 98 participants. This study led to Olaparib's Phase 1 drug approval and today there are 1114 active studies in 3058 cities from 66 countries around the world."

Answered by AI

What is the upper limit of participants for this research endeavor?

"Affirmative. Clinicaltrials.gov suggests that this medical trial is actively enrolling participants; it was first made available on March 3rd 2021 and the most recent update occurred April 30th 2021. The research requires 41 individuals from one location to take part in the study."

Answered by AI

Is enrolment in this experiment currently available to participants?

"This clinical trial, first posted on March 3rd 2021, is actively recruiting study participants. The data hosted by clinicaltrials.gov was last updated April 30th of this year."

Answered by AI

How can the risk of adverse effects be minimized when administering Olaparib?

"The safety of Olaparib is rated as a 2 on our scale, based off the fact that Phase 2 trials have only demonstrated preliminary evidence regarding its safety but no proof of efficacy."

Answered by AI
~10 spots leftby Feb 2025