Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 (NCT05482074) | Clinical Trial Compass
WithdrawnPhase 2
Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2
Stopped: Principal Investigator left the institute
0Started 2022-10-04
Plain-language summary
The purpose of this study is to evaluate how effective Olaparib is when given as a treatment for primary or recurrent, unresectable or metastatic melanoma. This research study involves targeted therapy.
-The name of the study drug involved in this study is: Olaparib (also known as Lynparza)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must have histologically or cytologically confirmed diagnosis of primary or recurrent metastatic melanoma including cutaneous, mucosal, or uveal melanoma.
* Participants must have a germline or somatic DNA damage repair mutation or deletion in BRCA1 or BRCA2. The result may have been obtained from one of the following test providers: OncoPanel, SNaPshot Panel, Myriad Genetics, Invitae, Ambry, Quest, Colour Genomics, IMPACT, Foundation Medicine (tissue or ctDNA based), Guardant, or another CLIA approved tissue and/or serum based next generation sequencing-based assay. (Variants of uncertain significance are excluded.)
* Participants must have measurable disease as defined by RECIST 1.1 criteria
* At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) (or Clinical examination) and which is suitable for accurate repeated measurements.
* Subjects must have received prior checkpoint inhibitor therapy (defined as anti-CTLA4 or anti-PD-1 or combination anti-CTLA4/anti-PD-1), either for metastatic or unresectable disease or progressed on adjuvant therapy.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of olaparib in participants \<18 years of age, children are excluded from this study, but will be eligible for …