Phase II study of olaparib in combination with pembrolizumab in patients with advanced melanoma with homologous recombination (HR) pathway gene mutation

The purpose of this research is to test if the combination of two drugs, olaparib and pembrolizumab, is safe and effective in improving your disease status and/or delaying progression of your disease. The use of these drugs in this research is investigational.

For more information, visit: https://clinicaltrials.gov/study/NCT04633902

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

1. Histologically confirmed diagnosis of unresectable or metastatic stage III or IV melanoma. 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
2. Disease must be refractory or resistant to anti PD-1 therapy (defined as disease progression within 6 months after the last dose of anit 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
3. Prior systemic cytotoxic therapy up to 1 regimen is allowed; There is no limit on the number of prior immunotherapy or targeted therapy regimens. 

1. Has received prior therapy with PARP inhibitor
2. Has a history of (non-infectious) pneumonitis due to a single agent PD-1 / PD-L1 antibody therapy that required steroids or has current pneumonitis.
3. Has active autoimmune disease that has required systemic treatment in the past 2 years
4. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
5. Previous solid organ or allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT) for solid tumors.