OncoMatch/Clinical Trials/NCT05222971
Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy
Is NCT05222971 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Olaparib for biliary tract cancer.
Treatment: Durvalumab · Olaparib — First-line gemcitabine plus cisplatin chemotherapy is the standard first-line treatment for unresectable or metastatic advanced biliary tract cancer and the optimal duration of the treatment is not mentioned in current clinical guidelines. In the pivotal phase 3 ABC-02 trial, patients received up to 6 to 8 cycles of treatment and stopped without maintenance and our retrospective study shows no significant benefit of continuing gemcitabine plus cisplatin beyond 6 to 8 cycles. However, the survival outcomes of patients who completed 6 to 8 cycles of gemcitabine plus cisplatin without progression are dismal with progression-free survival from the last dose of the treatment of median 5.2 months in a prior retrospective study. Indeed, there is an unmet clinical need in terms of maintenance therapy for advanced biliary tract cancer without progression to first-line gemcitabine plus cisplatin chemotherapy. Durvalumab with/without tremelimumab, anti-CTLA4 inhibitor, showed encouraging results in recently presented study for treatment of advanced biliary tract cancer combination with gemcitabine plus cisplatin. Combination of olaparib and durvalumab showed promising results for metastatic HER-2 negative BRCA mutated breast cancer. For DDR gene mutated advanced biliary tract cancer, olaparib plus durvalumab combination may show synergistic effect with better efficacy than olaparib monotherapy. Both olaparib and durvalumab are relatively well tolerated compared to other cytotoxic chemotherapeutic agents. Olaparib may have some degree of myelosuppression, most patients are expected to well tolerate. Although combination of durvalumab and olaparib may cause additional adverse events, these also might be tolerable, considering that there are no overlapping toxicities between durvalumab and olaparib and the safety data for the combination of durvalumab with olaparib. Considering poor prognosis in patients with advanced biliary tract cancer and lack of maintenance treatment following scheduled first-line GemCis, clinical benefits with maintenance olaparib or olaparib plus durvalumab weigh more than the potential risks.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: ATM mutation
Required: ATR mutation
Required: BAP1 mutation
Required: BARD1 mutation
Required: BLM mutation
Required: BRCA1 mutation
Required: BRCA2 mutation
Required: BRIP1 mutation
Required: CHEK1 mutation
Required: CHEK2 mutation
Required: FANCA mutation
Required: FANCD2 mutation
Required: GEN1 mutation
Required: MLH1 mutation
Required: MRE11A mutation
Required: MSH2 mutation
Required: MSH6 mutation
Required: NBN mutation
Required: PALB2 mutation
Required: PMS2 mutation
Required: POLE mutation
Required: RAD50 mutation
Required: RAD51 mutation
Required: RAD51C mutation
Required: RAD51D mutation
Required: XRCC2 mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — first-line
Lab requirements
Blood counts
haemoglobin ≥10.0 g/dl with no blood transfusion in past 28 days, platelets ≥ 100 x 10^9/l, neutrophils ≥ 1.5 x 10^9/l
Kidney function
creatinine clearance estimated of ≥51 ml/min using cockcroft-gault or 24 hour urine test
Liver function
serum total bilirubin ≤ 1.5 x uln and alt or ast ≤ 2.5 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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