OncoMatch/Clinical Trials/NCT03786796
Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations
Is NCT03786796 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Olaparib for renal cell carcinoma.
Treatment: Olaparib — Single arm, single site, open-label Phase II study of the effects of oral olaparib in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy. Must have measurable disease on CT imaging per RECIST 1.1 criteria.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Biomarker criteria
Required: BAP1 somatic or germline mutation
Somatic or germline mutation in BAP-1
Required: ATM somatic or germline mutation
Somatic or germline mutation in ATM
Required: BRCA1 somatic or germline mutation
Somatic or germline mutation in BRCA1
Required: BRCA2 somatic or germline mutation
Somatic or germline mutation in BRCA2
Required: PALB2 somatic or germline mutation
Somatic or germline mutation in PALB2
Required: CHEK2 somatic or germline mutation
Somatic or germline mutation in CHEK2
Required: BRIP1 somatic or germline mutation
Somatic or germline mutation in BRIP1
Required: RAD51C somatic or germline mutation
Somatic or germline mutation in RAD51C
Required: BARD1 somatic or germline mutation
Somatic or germline mutation in BARD1
Required: CDK12 somatic or germline mutation
Somatic or germline mutation in CDK12
Required: CHEK1 somatic or germline mutation
Somatic or germline mutation in CHEK1
Required: FANCL somatic or germline mutation
Somatic or germline mutation in FANCL
Required: PP2R2A somatic or germline mutation
Somatic or germline mutation in PP2R2A
Required: RAD51B somatic or germline mutation
Somatic or germline mutation in RAD51B
Required: RAD51D somatic or germline mutation
Somatic or germline mutation in RAD51D
Required: RAD54L somatic or germline mutation
Somatic or germline mutation in RAD54L
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-angiogenic agent
at least one prior treatment with an anti-angiogenic agent
Must have received: immune checkpoint inhibitor
at least one prior treatment with an immune checkpoint inhibitor
Cannot have received: PARP inhibitor (olaparib)
Any previous treatment with PARP inhibitor, including olaparib
Cannot have received: allogenic bone marrow transplant or double umbilical cord blood transplantation
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Lab requirements
Blood counts
Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days; ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L
Kidney function
Creatinine clearance ≥ 40 mL/min calculated by Cockroft-Gault formula or 24 hour urine test
Liver function
Total bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5 x ULN
Cardiac function
Resting ECG with QTc ≤ 500 ms and no indication of uncontrolled cardiac conditions
Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days; ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Total bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5 x ULN. Patients must have a creatinine clearance ≥ 40 mL/min calculated by Cockroft-Gault formula or 24 hour urine test. Resting ECG with QTc > 500 ms and/or indication of uncontrolled cardiac conditions [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify