OncoMatch/Clinical Trials/NCT03682289
Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors
Is NCT03682289 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ceralasertib and Olaparib for clear cell renal cell carcinoma.
Treatment: Ceralasertib · Olaparib · Durvalumab — This phase II trial studies how well ceralasertib, am Ataxia telangiectasia and Rad3-related (ATR) kinase inhibitor, works alone or in combination with olaparib or durvalumab in treating participants with renal cell carcinoma (RCC), urothelial carcinoma, all pancreatic cancers, endometrial cancer, and other solid tumors excluding clear cell ovarian cancer that have spread to nearby tissue or lymph nodes or other parts of the body. ATR kinase inhibitor AZD6738 and olaparib or durvalumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if giving ATR kinase inhibitor AZD6738 with or without olaparib or durvalumab may work better in treating participants with solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Pancreatic Cancer
Tumor Agnostic
Urothelial Carcinoma
Endometrial Cancer
Prostate Cancer
Biomarker criteria
Required: ARID1A pathogenic mutation
presence of pathogenic ARID1A alteration on CLIA-approved next-generation sequencing panel
Required: ARID1A loss of BAF250a expression
BAF250a expression by ARID1A immunohistochemistry
Required: ATM pathogenic mutation
pathogenic ATM mutation in CLIA-approved assay
Required: ATM loss of expression (< 5% of tumor cells expressing ATM)
loss of ATM expression by IHC (Ventana Ab)
Required: MSH2 intact mismatch repair protein (intact)
presence of intact mismatch repair proteins by immunohistochemistry
Required: MSH6 intact mismatch repair protein (intact)
presence of intact mismatch repair proteins by immunohistochemistry
Required: MLH1 intact mismatch repair protein (intact)
presence of intact mismatch repair proteins by immunohistochemistry
Required: PMS2 intact mismatch repair protein (intact)
presence of intact mismatch repair proteins by immunohistochemistry
Disease stage
Required: Stage III, IV
Excluded: Stage STAGE I UTERINE CANCER
Histologically confirmed locally advanced or metastatic solid tumor malignancy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — locally advanced or metastatic
progression on at least one prior systemic therapy
Must have received: androgen signaling inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) — castration resistant prostate cancer
Prior treatment with at least one androgen signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide)
Must have received: immune checkpoint inhibitor — endometrial cancer, locally advanced or metastatic
progression on at least one prior line of therapy containing an immune checkpoint inhibitor that was administered for a minimum duration of 6 weeks
Cannot have received: ATR inhibitor
Prior treatment with ATR inhibitor
Lab requirements
Blood counts
Hemoglobin >= 9.0 g/dL (no transfusion within 14 days); Platelets > 100,000 x 10^9/L; ANC > 1.5 x 10^9/L
Kidney function
Estimated GFR >= 45 ml/min (Cockcroft-Gault or 24h urine)
Liver function
AST/ALT < 2.5 x ULN (< 5x ULN in patients with known liver metastases); total bilirubin < 1.5 x ULN (direct bilirubin < 1.5 x ULN in patients with known Gilbert's disease or UGT1A1 homozygote)
Cardiac function
QTcF <= 470 ms (females) or <= 450 ms (males); no recent MI, unstable angina, TIA/CVA, uncontrolled arrhythmia, class III/IV CHF, or LV EF < 50%
Adequate organ function as defined by: Hemoglobin (Hgb) >= 9.0 g/dL in the absence of transfusion within 14 days prior to screening laboratory assessment. Platelets (Plt) count > 100,000 x 10^9/L. Absolute neutrophil count > 1.5 x 10^9/L. Estimated glomerular filtration rate (GFR) >= 45 ml/min based on Cockcroft-Gault equation or 24 hour urine collection. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) (< 5x ULN in patients with known liver metastases). Total bilirubin < 1.5 x ULN (direct bilirubin < 1.5 x ULN in patients with known Gilbert's disease or UGT1A1 homozygote). Fridericia's QT correction formula (QTcF) > 470 ms (females) or > 450 ms (males) on screening electrocardiography (ECG), or immediate family history of congenital long QT syndrome or sudden cardiac death at age less than 40.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
- University of California, San Francisco · San Francisco, California
- University of Chicago Comprehensive Cancer Center · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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