Actively Recruiting
Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-03-30
20
Participants Needed
1
Research Sites
456 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent before any study procedures
- Age 18 years or older
- Histological confirmation of renal cell carcinoma (clear cell or non-clear cell)
- Metastatic renal cell carcinoma (AJCC Stage IV)
- Somatic or germline mutation in specified DNA repair genes confirmed by clinical genetic testing
- Prior treatment with at least one anti-angiogenic agent or immune checkpoint inhibitor
- Any number of prior systemic therapies allowed
- Measurable disease per RECIST 1.1 criteria
- Normal organ and bone marrow function within 28 days before treatment, including hemoglobin ≥ 10.0 g/dL without recent transfusion, ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases present)
- Creatinine clearance ≥ 40 mL/min
- ECOG performance status ≤ 1
- Life expectancy of at least 16 weeks
- Women of childbearing potential must be postmenopausal or have evidence of non-childbearing status with negative pregnancy test
- Male patients must use condoms during treatment and for 3 months after when having intercourse with a pregnant woman or woman of childbearing potential
- Female partners of male patients of childbearing potential should use highly effective contraception
You will not qualify if you...
- Other malignancies unless curatively treated with no evidence of disease for 5 or more years, except certain treated skin and cervical cancers and select breast or endometrial cancers
- Symptomatic uncontrolled brain metastases or spinal cord compression without stable disease
- Previous allogenic bone marrow or double umbilical cord blood transplant
- Inability or unwillingness to comply with study requirements
- Breastfeeding women
- Use of prohibited medications within 2 weeks prior
- Involvement in planning or conduct of this study
- Participation in another investigational drug study within 2 weeks
- Recent systemic chemotherapy or radiotherapy within 3 weeks (except palliative)
- Prior treatment with any PARP inhibitor
- Resting ECG with QTc > 500 ms or uncontrolled cardiac conditions
- Use of strong or moderate CYP3A inhibitors or inducers without required washout
- Persistent toxicities from previous cancer therapy greater than grade 2 (except alopecia)
- Diagnosis or suspicion of myelodysplastic syndrome or acute myeloid leukemia
- Major surgery within 2 weeks prior to treatment without recovery
- Serious uncontrolled medical disorders or infections
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Immunocompromised status including HIV
- Known hypersensitivity to olaparib or its components
- Active hepatitis B or C infection
- Recent red blood cell or platelet transfusions within 28 days prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21228
Actively Recruiting
Research Team
I
Irina Rifkind, RN, MSN
CONTACT
R
Rana Sullivan, RN, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here