Clinical trial · Interventional
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy
- 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)
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
Conditions
Conditions (3)
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 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M7824 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- M7824
- interventionNames
- Drug: M7824
Primary outcomes (1)
- measure
- Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
- timeFrame
- Time from first treatment up to 555 days
- description
- Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.
Secondary outcomes (18)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC. * Availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory * Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy administered for locally advanced or metastatic disease. Only one prior treatment line is allowed * Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1 * Life expectancy \>= 12 weeks as judged by the Investigator * Adequate hematological function defined by white blood cell (WBC) count \>= 3 \* 10\^9/Litre with absolute neutrophil count (ANC) \>= 1.5 \* 109/Litre, lymphocyte count \>= 0.5 \* 10\^9/Litre, platelet count \>=75 \* 10\^9/Litre, and hemoglobin (Hgb) \>= 9 grams/decilitre * Adequate hepatic function defined by a total bilirubin level =\< 1.5 \* upper limit of normal (ULN), an aspartate aminotransferase (AST) level =\< 2.5 \* ULN, and an alanine aminotransferase (ALT) level =\<2.5 \* ULN. For participants with liver involvement in their tumor, AST =\< 5.0 \* ULN and ALT =\< 5.0 \* ULN is acceptable * Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) =\< 1.5 \* ULN unless the participant is receiving anticoagulant therapy * Albumin \>= 3.0 grams/decilitre * Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals * Adequate renal function defined by either creatinine =\< 1.5 \* ULN or an estimated creatinine clearance (CCr) \> 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Ampullary cancer was excluded * Significant acute or chronic infections * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent * Interstitial lung disease or its history * Participants who were not eligible for or have not been treated with 1L systemic chemotherapy * Anticancer treatment within 21 days before the start of study intervention * Concurrent treatment with nonpermitted drugs * Prior participation in a M7824 clinical trial * Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies. * Pregnancy or breast feeding * Systemic anticancer treatment after failing 1L platinum-based chemotherapy * Other protocol defined exclusion criteria could apply
References
Publications (3)
- RESULTYoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564. PMID 32461347
- DERIVEDMilenkovic-Grisic AM, Terranova N, Mould DR, Vugmeyster Y, Mrowiec T, Machl A, Girard P, Venkatakrishnan K, Khandelwal A. Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non-small cell lung cancer based on bintrafusp alfa trials. CPT Pharmacometrics Syst Pharmacol. 2024 Jan;13(1):143-153. doi: 10.1002/psp4.13068. Epub 2023 Dec 13. PMID 38087967
- DERIVEDYoo C, Javle MM, Verdaguer Mata H, de Braud F, Trojan J, Raoul JL, Kim JW, Ueno M, Lee CK, Hijioka S, Cubillo A, Furuse J, Azad N, Sato M, Vugmeyster Y, Machl A, Bajars M, Bridgewater J, Oh DY, Borad MJ. Phase 2 trial of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers. Hepatology. 2023 Sep 1;78(3):758-770. doi: 10.1097/HEP.0000000000000365. Epub 2023 Apr 1. PMID 36999533