Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026
A Phase II Multicenter Trial of Rucaparib and Nivolumab as Maintenance Therapy in Patients with Advanced Biliary Tract Cancer: BilT-02.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03639935 (Phase II Multi-Center Study of PARP Inhibitor Rucaparib in Combination With Anti-PD-1 Antibody Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy), which is not on this map. Not yet cited in PubMed.
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Phase II Multi-Center Study of PARP Inhibitor Rucaparib in Combination With Anti-PD-1 Antibody Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
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17 authors.
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Abstract
purposeThis phase II trial investigated rucaparib [poly (ADP-ribose) polymerase (PARP) inhibitor] in combination with nivolumab in patients with advanced biliary tract cancer (BTC) without progression after 4 to 6 months of first-line platinum-based chemotherapy. PATIENTS AND
methodsThe primary endpoint was the 4-month progression-free survival (PFS) rate with null and alternative hypotheses of 63% and 85%. Secondary endpoints included the PFS rate in patients with DNA damage response (DDR) and isocitrate dehydrogenase 1 (IDH1) mutations, median PFS and overall survival (OS) from the start of study treatment (PFS1 and OS1) and first-line chemotherapy (PFS2 and OS2), best overall response, and safety (NCT03639935).
resultsOf 31 patients, 24 (77.6%) had Eastern Cooperative Oncology Group performance status 1, and 22 (71%) had intrahepatic cholangiocarcinoma. Nine (29%) patients had DDR or IDH1 mutations [BRCA2 (n = 3), ATM (2), FANCA (1), and IDH1 (3)]. Four-month PFS rate was 54.8% [95% confidence intervals (CI), 36-72.7] in all patients and 83.3% and 100% in the DDR and IDH1 cohorts, respectively. Median PFS1 and OS1 were 4.6 months (95% CI, 3.7-6.2) and 15.9 months (95% CI, 9.8-24.1), respectively. Median PFS2 and OS2 were 9.9 months (95% CI, 8.3-11.3) and 21.4 months (95% CI, 14.8-26.7), respectively. Two (6.4%) patients had a partial response. The most common grade ≥3 treatment-related adverse events included anemia (12.9%), neutropenia (9.7%), and elevated liver enzymes (12.9%).
conclusionsThe primary endpoint of the PFS rate at 4 months was not met. The PFS rate at 4 months in the DDR and IDH1 cohorts was longer than expected and supports further investigation of the addition of a PARP inhibitor during maintenance immune checkpoint inhibition for DDR and IDH1-altered patients with BTC.
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