Investigation of Predictive Biomarkers in Patients With Advanced BTC Treated With Lenvatinib Plus Pembrolizumab

NCT06648057 | Recruiting

• 1 other identifier: CHAMC 2024-08-040
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the clinical efficacy and safety of lenvatinib plus pembrolizumab combination therapy in patients with advanced biliary tract cancer (BTC). This study aims to identify potential biomarkers that may predict treatment response by analyzing genetic data from blood and tissue samples. The study will focus on real-world clinical outcomes and the exploratory discovery of biomarkers associated with the efficacy of this treatment regimen.

Conditions

Biliary Tract Cancer; Cholangiocarcinoma

Keywords

Lenvatinib; Pembrolizumab; Biliary Tract Cancer; Biomarker; RNA sequencing

Outcome Measures

Primary Outcomes (2)

• collected tumor samples

  Tumor samples will be collected from patients with advanced biliary tract cancer. The incidence of genetic alterations in these samples will be analyzed using H\&E staining, immunohistochemistry (IHC), and RNA sequencing. The data will be reported as the percentage of patients with detectable genetic alterations and correlated with treatment response and survival duration.

  through study competition, an average of 2 years

• Collected Blood Samples

  Blood samples will be collected from patients with advanced biliary tract cancer.These samples will undergo flow cytometry, ELISA, and ctDNA analysis, and the results will be correlated with treatment response and survival outcomes. (PFS, OS).

  Through study completion, an average of 2 years

Secondary Outcomes (2)

• Multi-Omics Analysis for Therapeutic Target Identification

  Through study completion, an average of 2 years.

• Biomarkers on the Efficacy of Lenvatinib and Pembrolizumab for Advanced Biliary Tract Cancer

  Through study completion, an average of 2 years.

Other Outcomes (4)

• Progression-Free Survival (PFS)

  Through study completion, an average of 2 years.

• Overall Survival (OS)

  Through study completion, an average of 2 years.

• Objective Response Rate (ORR)

  Through study completion, an average of 2 years.

Study Arms (1)

Len/Pemb

lenvatinib plus pembrolizumab combination therapy.

Drug: lenvatinib plus pembrolizumab

Interventions

lenvatinib plus pembrolizumab DRUG

* The collection of peripheral blood samples will follow the schedule below (20 cc per collection, up to 5 times): * Before systemic therapy, at 3 weeks after starting systemic therapy (Cycle 1), at 6 weeks (Cycle 2) * (If possible) at the time of confirmed partial response (1 time), and at the time of disease progression (1 time). * Additional tumor tissue samples will be collected only if possible, according to the following schedule: If the patient undergoes surgery or additional biopsy related to treatment (collected from preserved specimens).

Also known as: Liquid biopsy, RNA-sequencing, NGS

Len/Pemb

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Advenced Biliary Tract Cancer will be recruited at CHA Bundang Medical Center

You may qualify if:

• Patients with histologically or cytologically confirmed advanced biliary tract cancer.
• Patients scheduled to receive Lenvatinib + Pembrolizumab for the treatment of advanced biliary tract cancer.
• ECOG performance status of 0-2.
• Patients aged 20 years or older at the time of treatment initiation.
• Patients who understand and consent to participate in this study, and agree to provide samples obtained during the examination process.

You may not qualify if:

• Patients who do not consent to participate in the study or withdraw their consent.

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

Related Publications (7)

• Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

  PMID: 20375404 RESULT

• Oh DY, Ruth He A, Qin S, Chen LT, Okusaka T, Vogel A, Kim JW, Suksombooncharoen T, Ah Lee M, Kitano M, Burris H, Bouattour M, Tanasanvimon S, McNamara MG, Zaucha R, Avallone A, Tan B, Cundom J, Lee CK, Takahashi H, Ikeda M, Chen JS, Wang J, Makowsky M, Rokutanda N, He P, Kurland JF, Cohen G, Valle JW. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022 Aug;1(8):EVIDoa2200015. doi: 10.1056/EVIDoa2200015. Epub 2022 Jun 1.

  PMID: 38319896 RESULT

• Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.

  PMID: 37075781 RESULT

• Lamarca A, Palmer DH, Wasan HS, Ross PJ, Ma YT, Arora A, Falk S, Gillmore R, Wadsley J, Patel K, Anthoney A, Maraveyas A, Iveson T, Waters JS, Hobbs C, Barber S, Ryder WD, Ramage J, Davies LM, Bridgewater JA, Valle JW; Advanced Biliary Cancer Working Group. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021 May;22(5):690-701. doi: 10.1016/S1470-2045(21)00027-9. Epub 2021 Mar 30.

  PMID: 33798493 RESULT

• Shi C, Li Y, Yang C, Qiao L, Tang L, Zheng Y, Chen X, Qian Y, Yang J, Wu D, Xie F. Lenvatinib Plus Programmed Cell Death Protein-1 Inhibitor Beyond First-Line Systemic Therapy in Refractory Advanced Biliary Tract Cancer: A Real-World Retrospective Study in China. Front Immunol. 2022 Jul 27;13:946861. doi: 10.3389/fimmu.2022.946861. eCollection 2022.

  PMID: 35967452 RESULT

• Lin J, Yang X, Long J, Zhao S, Mao J, Wang D, Bai Y, Bian J, Zhang L, Yang X, Wang A, Xie F, Shi W, Yang H, Pan J, Hu K, Guan M, Zhao L, Huo L, Mao Y, Sang X, Wang K, Zhao H. Pembrolizumab combined with lenvatinib as non-first-line therapy in patients with refractory biliary tract carcinoma. Hepatobiliary Surg Nutr. 2020 Aug;9(4):414-424. doi: 10.21037/hbsn-20-338.

  PMID: 32832493 RESULT

• Li L, Yu D, Yang J, Zhang F, Zhang D, Lin Z, Zhai M, Wang J, Zhang T, Zhao L. Significant response to pembrolizumab plus lenvatinib in Epstein-Barr-virus-associated intrahepatic cholangiocarcinoma: a case report. Cancer Biol Ther. 2024 Dec 31;25(1):2338644. doi: 10.1080/15384047.2024.2338644. Epub 2024 Apr 22.

  PMID: 38650446 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, Blood

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma

Interventions

lenvatinib; pembrolizumab; Liquid Biopsy; Base Sequence

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Hong Jae Chon, MD. PhD

  CHA University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jae Chon, MD. PhD

CONTACT

82-31-780-3928; minidoctor@cha.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 18, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)