---
title: "Trastuzumab + nivolumab with gemcitabine–cisplatin as first-line therapy for HER2-positive unresec"
id: "nature-3-trastuzumab-plus-nivolumab-with-gemcitabine-and-cisplatin-as-first-line-therapy"
canonical_url: "https://medichelpline.com/clinical-feed/nature-3-trastuzumab-plus-nivolumab-with-gemcitabine-and-cisplatin-as-first-line-therapy"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04679-x"
published_at: "2026-09-22T12:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Trastuzumab + nivolumab with gemcitabine–cisplatin as first-line therapy for HER2-positive unresec
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-3-trastuzumab-plus-nivolumab-with-gemcitabine-and-cisplatin-as-first-line-therapy
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04679-x)
- **Published At:** 2026-09-22T12:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- This multi-institutional, open-label phase 1b/2 HERBOT trial evaluated an upfront quadruplet regimen of **trastuzumab**, **nivolumab**, **gemcitabine** and **cisplatin** in patients with HER2-positive unresectable biliary tract cancer (BTC). - The primary endpoint was met: an **objective response rate (ORR)** of 55% (95% CI 38.5–70.7) among 40 participants, including one complete response and 21 partial responses. - The **disease control rate** was 95% (95% CI 83.5–99.4); median duration of response was 12.6 months (95% CI 5.7–not reached). - With a median follow-up of 17.0 months, median **progression-free survival (PFS)** was 10.6 months (95% CI 7.8–17.4); median overall survival (OS) was not reached at data cutoff. - Two participants (5.0%) underwent curative-intent conversion surgery after therapy. - Common grade ≥3 treatment-related adverse events included **neutropenia** (57.5%), **anemia** (30.0%) and **thrombocytopenia** (22.5%). - Preplanned artificial-intelligence-powered whole-slide image analyses indicated that tumors with higher proportions of **HER2 3+** cells correlated with greater clinical benefit. - The study supports the concept of upfront **HER2-targeted therapeutic intensification** in BTC and is relevant to ongoing phase 3 investigations. ClinicalTrials.gov identifier: NCT05749900.
## Clinical Analysis & Structured Key Points
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[articles](https://www.nature.com/nm/articles?type=article) 4. article Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial [ Download PDF ](https://www.nature.com/articles/s41591-026-04679-x.pdf) [ Download PDF ](https://www.nature.com/articles/s41591-026-04679-x.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 22 September 2026 # Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial * [Choong-kun Lee](https://www.nature.com/articles/s41591-026-04679-x#auth-Choong_kun-Lee-Aff1-Aff2) [ORCID: orcid.org/0000-0001-5151-5096](https://orcid.org/0000-0001-5151-5096)[1](https://www.nature.com/articles/s41591-026-04679-x#Aff1),[2](https://www.nature.com/articles/s41591-026-04679-x#Aff2), * [Taek Chung](https://www.nature.com/articles/s41591-026-04679-x#auth-Taek-Chung-Aff3)[3](https://www.nature.com/articles/s41591-026-04679-x#Aff3), * [Il Hwan Kim](https://www.nature.com/articles/s41591-026-04679-x#auth-Il_Hwan-Kim-Aff4)[4](https://www.nature.com/articles/s41591-026-04679-x#Aff4), * [Hong Jae Chon](https://www.nature.com/articles/s41591-026-04679-x#auth-Hong_Jae-Chon-Aff5)[5](https://www.nature.com/articles/s41591-026-04679-x#Aff5), * [Jin Won Kim](https://www.nature.com/articles/s41591-026-04679-x#auth-Jin_Won-Kim-Aff6) [ORCID: orcid.org/0000-0002-1357-7015](https://orcid.org/0000-0002-1357-7015)[6](https://www.nature.com/articles/s41591-026-04679-x#Aff6), * [Se Jun Park](https://www.nature.com/articles/s41591-026-04679-x#auth-Se_Jun-Park-Aff7) [ORCID: orcid.org/0000-0001-5486-9818](https://orcid.org/0000-0001-5486-9818)[7](https://www.nature.com/articles/s41591-026-04679-x#Aff7), * [Woo Kyun Bae](https://www.nature.com/articles/s41591-026-04679-x#auth-Woo_Kyun-Bae-Aff8)[8](https://www.nature.com/articles/s41591-026-04679-x#Aff8), * [Junghun Kang](https://www.nature.com/articles/s41591-026-04679-x#auth-Junghun-Kang-Aff9)[9](https://www.nature.com/articles/s41591-026-04679-x#Aff9), * [Changhoon Yoo](https://www.nature.com/articles/s41591-026-04679-x#auth-Changhoon-Yoo-Aff10)[10](https://www.nature.com/articles/s41591-026-04679-x#Aff10), * [Dong-Hoe Koo](https://www.nature.com/articles/s41591-026-04679-x#auth-Dong_Hoe-Koo-Aff11) [ORCID: orcid.org/0000-0001-9913-8883](https://orcid.org/0000-0001-9913-8883)[11](https://www.nature.com/articles/s41591-026-04679-x#Aff11), * [Sora Kang](https://www.nature.com/articles/s41591-026-04679-x#auth-Sora-Kang-Aff12)[12](https://www.nature.com/articles/s41591-026-04679-x#Aff12), * [Minsuk Kwon](https://www.nature.com/articles/s41591-026-04679-x#auth-Minsuk-Kwon-Aff13) [ORCID: orcid.org/0000-0003-1833-6576](https://orcid.org/0000-0003-1833-6576)[13](https://www.nature.com/articles/s41591-026-04679-x#Aff13), * [Ju Won Kim](https://www.nature.com/articles/s41591-026-04679-x#auth-Ju_Won-Kim-Aff14)[14](https://www.nature.com/articles/s41591-026-04679-x#Aff14), * [Beodeul Kang](https://www.nature.com/articles/s41591-026-04679-x#auth-Beodeul-Kang-Aff5) [ORCID: orcid.org/0000-0001-5177-8937](https://orcid.org/0000-0001-5177-8937)[5](https://www.nature.com/articles/s41591-026-04679-x#Aff5), * [Sejung Park](https://www.nature.com/articles/s41591-026-04679-x#auth-Sejung-Park-Aff2)[2](https://www.nature.com/articles/s41591-026-04679-x#Aff2), * [Woochan Hwang](https://www.nature.com/articles/s41591-026-04679-x#auth-Woochan-Hwang-Aff15)[15](https://www.nature.com/articles/s41591-026-04679-x#Aff15), * [Chang Ho Ahn](https://www.nature.com/articles/s41591-026-04679-x#auth-Chang_Ho-Ahn-Aff15)[15](https://www.nature.com/articles/s41591-026-04679-x#Aff15), * [Chang Gon Kim](https://www.nature.com/articles/s41591-026-04679-x#auth-Chang_Gon-Kim-Aff1)[1](https://www.nature.com/articles/s41591-026-04679-x#Aff1) & * … * [Hye Jin Choi](https://www.nature.com/articles/s41591-026-04679-x#auth-Hye_Jin-Choi-Aff1)[1](https://www.nature.com/articles/s41591-026-04679-x#Aff1) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04679-x#citeas) [ Save article ](https://www.nature.com/articles/s41591-026-04679-x/save-research?_csrf=ju-7uz1dfJfCy4jF_mhdipSRqziNzvut) [ View saved research ](https://www.nature.com/saved-research) ## Abstract Biliary tract cancers (BTCs) are associated with poor outcomes despite recent incorporation of immune checkpoint inhibitors into first-line chemotherapy. Human epidermal growth factor receptor 2 (HER2) overexpression or amplification defines a therapeutically targetable subset of BTC but its integration into first-line chemoimmunotherapy has not been prospectively evaluated. This multi-institutional, open-label, phase 1b/2 HERBOT study (KCSG-HB23-05) aimed to evaluate first-line HER2-targeted quadruplet regimen consisting of trastuzumab, nivolumab, gemcitabine and cisplatin in participants with HER2-positive advanced BTC. Here the primary endpoint was met with an objective response rate of 55% (95% confidence interval (CI) 38.5–70.7; one complete response and 21 partial responses among 40 participants) and a disease control rate of 95% (95% CI 83.5–99.4); the median duration of response was 12.6 months (95% CI 5.7–not reached). With a median follow-up of 17.0 months, the median progression-free survival was 10.6 months (95% CI 7.8–17.4) and median overall survival was not reached. Two participants (5.0%) underwent curative-intent conversion surgery. Common grade ≥3 treatment-related adverse events included neutropenia (57.5%), anemia (30.0%) and thrombocytopenia (22.5%). Preplanned artificial-intelligence-powered whole-slide image analyses suggested that tumors with higher proportions of HER2 3+ cells were associated with greater clinical benefit. These findings suggest that upfront HER2-targeted therapeutic intensification in BTC may represent a promising direction for future first-line treatment strategies, with relevance to ongoing phase 3 studies. ClinicalTrials.gov identifier: [NCT05749900](https://clinicaltrials.gov/study/NCT05749900). ### Explore related subjects Discover the latest articles and news in related subjects. * [Outcomes research](https://www.nature.com/subjects/outcomes-research) * [Targeted therapies](https://www.nature.com/subjects/targeted-therapies) ## Main Biliary tract cancers (BTCs) comprise a heterogeneous group of malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer (GBC), and are associated with poor prognosis and limited therapeutic options. The incidence and mortality of BTCs have increased worldwide over the past two decades[1](https://www.nature.com/articles/s41591-026-04679-x#ref-CR1 "Banales, J. M. et al. Cholangiocarcinoma 2026: status quo, unmet needs and priorities. Nat. Rev. Gastroenterol. Hepatol. 23, 65–96 \(2026\)."),[2](https://www.nature.com/articles/s41591-026-04679-x#ref-CR2 "Roa, J. C. et al. Gallbladder cancer. Nat. Rev. Dis. Primers 8, 69 \(2022\)."). The current first-line standard of care for advanced BTC consists of immune checkpoint inhibitors (ICIs), such as anti-PDL1 durvalumab or anti-PD1 pembrolizumab, in combination with gemcitabine and cisplatin, according to recent phase 3 trials[3](https://www.nature.com/articles/s41591-026-04679-x#ref-CR3 "Ueno, M. et al. Nivolumab alone or in combination with cisplatin plus gemcitabine in Japanese patients with unresectable or recurrent biliary tract cancer: a non-randomised, multicentre, open-label, phase 1 study. Lancet Gastroenterol. Hepatol. 4, 611–621 \(2019\)."),[4](https://www.nature.com/articles/s41591-026-04679-x#ref-CR4 "Kim, R. D. et al. A phase 2 multi-institutional study of nivolumab for patients with advanced refractory biliary tract cancer. JAMA Oncol. 6, 888–894 \(2020\)."),[5](https://www.nature.com/articles/s41591-026-04679-x#ref-CR5 "Oh, D. Y. et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. 1, EVIDoa2200015 \(2022\)."),[6](https://www.nature.com/articles/s41591-026-04679-x#ref-CR6 "Kelley, R. K. et al. 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 401, 1853–1865 \(2023\)."). Nonetheless, most patients ultimately experience disease progression, with a median progression-free survival (PFS) of approximately 7 months and an overall survival (OS) slightly exceeding 1 year, highlighting the need for more effective first-line strategies. Human epidermal growth factor receptor 2 (HER2; also known as erythroblastic oncogene B2, ERBB2) overexpression or amplification is observed in approximately 15% of BTCs and is associated with poor clinical outcomes, while also representing a clinically actionable therapeutic target[7](https://www.nature.com/articles/s41591-026-04679-x#ref-CR7 "Vivaldi, C. et al. HER2 overexpression as a poor prognostic determinant in resected biliary tract cancer. Oncologist 25, 886–893 \(2020\)."),[8](https://www.nature.com/articles/s41591-026-04679-x#ref-CR8 "Hiraoka, N. et al. Details of human epidermal growth factor receptor 2 status in 454 cases of biliary tract cancer. Hum. Pathol. 105, 9–19 \(2020\)."),[9](https://www.nature.com/articles/s41591-026-04679-x#ref-CR9 "Lee, S. H. et al. ARID1A mutation from targeted next-generation sequencing predicts primary resistance to gemcitabine and cisplatin chemotherapy in advanced biliary tract cancer. Cancer Res. Treat. 55, 1291–1302 \(2023\)."),[10](https://www.nature.com/articles/s41591-026-04679-x#ref-CR10 "Lee, S. S. et al. HER2-positivity as a prognostic biomarker and therapeutic target in advanced biliary tract cancer: a multi-institutional analysis. Clin. Cancer Res. 32, 1745–1754 \(2026\)."). In BTC, however, the clinical development of HER2-targeted therapies has largely been limited to later-line settings. Prospective studies of various HER2-targeted regimens have demonstrated encouraging activity in previously treated patients, establishing HER2 as a therapeutically actionable alteration in this disease[11](https://www.nature.com/articles/s41591-026-04679-x#ref-CR11 "Javle, M. et al. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer \(MyPathway\): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 22, 1290–1300 \(2021\)."),[12](https://www.nature.com/articles/s41591-026-04679-x#ref-CR12 "Lee, C. K. et al. Trastuzumab plus FOLFOX for HER2-positive biliary tract cancer refractory to gemcitabine and cisplatin: a multi-institutional phase 2 trial of the Korean Cancer Study Group \(KCSG-HB19-14\). Lancet Gastroenterol. Hepatol. 8, 56–65 \(2023\)."),[13](https://www.nature.com/articles/s41591-026-04679-x#ref-CR13 "Harding, J. J. et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer \(HERIZON-BTC-01\): a multicentre, single-arm, phase 2b study. Lancet Oncol. 24, 772–782 \(2023\)."),[14](https://www.nature.com/articles/s41591-026-04679-x#ref-CR14 "Nakamura, Y. et al. Tucatinib and trastuzumab for previously treated human epidermal growth factor receptor 2-positive metastatic biliary tract cancer \(SGNTUC-019\): a phase II basket study. J. Clin. Oncol. 41, 5569–5578 \(2023\)."),[15](https://www.nature.com/articles/s41591-026-04679-x#ref-CR15 "Ohba, A. et al. Trastuzumab deruxtecan in human epidermal growth factor receptor 2-expressing biliary tract cancer \(HERB; NCCH1805\): a multicenter, single-arm, phase II trial. J. Clin. Oncol. 42, 3207–3217 \(2024\)."). However, these approaches have not been systematically evaluated in the first-line setting, particularly in combination with current standard-of-care chemoimmunotherapy regimens. Given the aggressive clinical course of BTC and the risk of early treatment failure, a substantial proportion of patients may not receive later-line HER2-targeted therapy, highlighting the need to explore upfront integration strategies. Emerging evidence suggests that HER2-targeted therapies may modulate the tumor microenvironment and enhance antitumor immunity[16](https://www.nature.com/articles/s41591-026-04679-x#ref-CR16 "Muller, P. et al. Trastuzumab emtansine \(T-DM1\) renders HER2+ breast cancer highly susceptible to CTLA-4/PD-1 blockade. Sci. Transl. Med. 7, 315ra188 \(2015\)."),[17](https://www.nature.com/articles/s41591-026-04679-x#ref-CR17 "Chaganty, B. K. R. et al. Trastuzumab upregulates PD-L1 as a potential mechanism of trastuzumab resistance through engagement of immune effector cells and stimulation of IFNγ secretion. Cancer Lett. 430, 47–56 \(2018\)."). HER2-directed antibodies can promote antigen release and cross-presentation, activate HER2-specific T cell responses and induce antibody-dependent cellular cytotoxicity, while chemotherapy may further augment antigen presentation through tumor cell death, collectively providing a rationale for combining HER2-targeted therapy with ICIs[18](https://www.nature.com/articles/s41591-026-04679-x#ref-CR18 "zum Buschenfelde, C. M., Hermann, C., Schmidt, B., Peschel, C. & Bernhard, H. Antihuman epidermal growth factor receptor 2 \(HER2\) monoclonal antibody trastuzumab enhances cytolytic activity of class I-restricted HER2-specific T lymphocytes against HER2-overexpressing tumor cells. Cancer Res. 62, 2244–2247 \(2002\)."),[19](https://www.nature.com/articles/s41591-026-04679-x#ref-CR19 "Park, S. et al. The therapeutic effect of anti-HER2/neu antibody depends on both innate and adaptive immunity. Cancer Cell 18, 160–170 \(2010\)."),[20](https://www.nature.com/articles/s41591-026-04679-x#ref-CR20 "Stagg, J. et al. Anti-ErbB-2 mAb therapy requires type I and II interferons and synergizes with anti-PD-1 or anti-CD137 mAb therapy. Proc. Natl Acad. Sci. USA 108, 7142–7147 \(2011\)."),[21](https://www.nature.com/articles/s41591-026-04679-x#ref-CR21 "Triulzi, T. et al. HER2 signaling regulates the tumor immune microenvironment and trastuzumab efficacy. Oncoimmunology 8, e1512942 \(2019\)."),[22](https://www.nature.com/articles/s41591-026-04679-x#ref-CR22 "Ghiringhelli, F. et al. Activation of the NLRP3 inflammasome in dendritic cells induces IL-1β-dependent adaptive immunity against tumors. Nat. Med. 15, 1170–1178 \(2009\)."). This therapeutic strategy has already transformed treatment paradigms in HER2-positive gastric and gastroesophageal junction cancers. For example, in the phase 3 KEYNOTE-811 trial, the addition of pembrolizumab to trastuzumab and chemotherapy significantly improved OS, establishing HER2-targeted chemoimmunotherapy as a first-line standard of care in these cancers[23](https://www.nature.com/articles/s41591-026-04679-x#ref-CR23 "Janjigian, Y. Y. et al. Pembrolizumab in HER2-positive gastric cancer. N. Engl. J. Med. 391, 1360–1362 \(2024\)."). This clinical success supports the rationale that HER2-targeted therapy and ICIs may act synergistically when combined upfront with c
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