Clinical trial · Interventional
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
A Phase II, Randomized, Double-Blind Placebo-Controlled Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Atezo+Bev+CisGem, followed by Atezo+Bev
- description
- Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
- interventionNames
- Drug: Atezolizumab
- Drug: Bevacizumab
- Drug: Cisplatin
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Atezo+PBO+CisGem, followed by Atezo+PBO
- description
- Participants will receive atezolizumab intravenously on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. Participants will receive placebo matching bevacizumab intravenously on Day 1 of each 21-day cycle. Participants will receive cisplatin intravenously followed by gemcitabine on Days 1 and 8 of each 21-day cycle for Cycles 1-8.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment * Documentation of recurrent/metastatic or locally advanced unresectable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) scans * Histologically or cytologically confirmed diagnosis of iCCA, eCCA, or GBC * No prior systemic therapy for advanced BTC * At least one measurable untreated lesion (per RECIST v1.1) * Adequate biliary drainage with no evidence of ongoing infection * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Life expectancy of \> 3 months * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: * Recurrent disease \<=6 months after curative surgery or \<= 6 months after the completion of adjuvant therapy * Prior local regional therapy such as radioembolization * Combined or mixed hepatocellular/cholangiocarcinoma * Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 of Cycle 1 * National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade \>= 2 peripheral neuropathy * Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to Day 1 of Cycle 1 * Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab, cisplatin or gemcitabine * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan * History of malignancy other than BTC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Symptomatic, untreated, or actively progressing CNS metastases * For patients with lung metastases, if one of the following criteria applies: Large, centrally located pulmonary metastases; Clear tumor infiltration into the thoracic great vessels seen on imaging; Clear cavitation of pulmonary lesions seen on imaging * Active tuberculosis * Co-infection with HBV and HCV * Treatment with systemic immunostimulatory agents or immunosuppressive medication * Inadequately controlled arterial hypertension * History of hypertensive crisis or hypertensive encephalopathy * Significant vascular disease * Evidence of bleeding diathesis or significant coagulopathy * Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture * Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID) * Preexisting renal impairment, myelosuppression, or hearing impairment
References
Publications (2)
- DERIVEDMacarulla T, Ren Z, Chon HJ, Park JO, Kim JW, Pressiani T, Li D, Zhukova L, Zhu AX, Chen MH, Hack SP, Wu S, Liu B, Guan X, Lu S, Wang Y, El-Khoueiry AB. Atezolizumab Plus Chemotherapy With or Without Bevacizumab in Advanced Biliary Tract Cancer: Clinical and Biomarker Data From the Randomized Phase II IMbrave151 Trial. J Clin Oncol. 2025 Feb 10;43(5):545-557. doi: 10.1200/JCO.24.00337. Epub 2024 Oct 18. PMID 39423355
- DERIVEDHack SP, Verret W, Mulla S, Liu B, Wang Y, Macarulla T, Ren Z, El-Khoueiry AB, Zhu AX. IMbrave 151: a randomized phase II trial of atezolizumab combined with bevacizumab and chemotherapy in patients with advanced biliary tract cancer. Ther Adv Med Oncol. 2021 Jul 31;13:17588359211036544. doi: 10.1177/17588359211036544. eCollection 2021. PMID 34377158