ArticleCancer medicine2022
Tolerability and efficacy of durvalumab, either as monotherapy or in combination with tremelimumab, in patients from Asia with advanced biliary tract, esophageal, or head-and-neck cancer.
Article in Cancer medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01938612 (A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours), which is not on this map. Cited by 49 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
Who cites it
49 citing papers in PubMed, 3 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Immunotherapy checkpoint inhibitor-combination therapy versus chemotherapy alone among Chinese population in cholangiocarcinoma treatment: a systematic review and meta-analysis.European journal of clinical pharmacology · 2026Pooled it
- The predictive value of PD-L1 expression in response to anti-PD-1/PD-L1 therapy for biliary tract cancer: a systematic review and meta-analysis.Frontiers in immunology · 2024Pooled it
- The role of immune checkpoint inhibitors in the first-line treatment for patients with advanced biliary tract cancer: a systematic review and meta-analysis of randomized trials.Frontiers in oncology · 2024Pooled it
- Trial
- A Phase II Trial of Pembrolizumab plus Granulocyte-Macrophage Colony-Stimulating Factor in Advanced Biliary Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Prognostic, Predictive, and Clinical Relevance of DNA Damage Repair Alterations in Biliary Tract Cancers.Cancers · 2026Review
- The Evolving Landscape of Immune Regulation and Immunotherapy in Cholangiocarcinoma and Biliary Tract Cancer.Cancers · 2026Review
- Review
- Current Status of Drug Treatment of Cholangiocarcinoma-Updated Progress and Critical Limitations.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Phase Ib multicenter study of anti-TIM-3 (S095018/Sym023) in combination with anti-PD-1 (Sym021) in patients with advanced/metastatic recurrent biliary tract cancer.Journal for immunotherapy of cancer · 2026Article
- New progress and clinical research translation of immune checkpoint inhibitors in systemic therapy of gallbladder cancer.Frontiers in immunology · 2026Review
- Harnessing the microbiome: unveiling the influence of the gut microbiota on hepatobiliary cancer therapeutic strategies.Clinical and molecular hepatology · 2026Review
- Research progress on immune checkpoint inhibitors in intrahepatic cholangiocarcinoma.Annals of medicine · 2025Review
- Recent advancements in systemic therapy for biliary tract cancers: a literature review.Journal of gastrointestinal oncology · 2025Review
- Targeted therapies and immunotherapies for unresectable cholangiocarcinoma.Chinese medical journal · 2025Review
- Real-world effectiveness and prognostic factors of durvalumab plus chemotherapy in a multicentric cohort with advanced biliary tract cancer.The oncologist · 2025Article
- Development and challenges in the treatment of advanced gallbladder cancer (Review).Oncology letters · 2025Review
- Combination of PD-1/PD-L1 and CTLA-4 inhibitors in the treatment of cancer - a brief update.Frontiers in immunology · 2025Review
- Ablatio-bilica: safety of biliary intraductal radiofrequency ablation in patients with unresectable extrahepatic biliary tract cancer undergoing systemic anti-tumor therapy: a phase II, multi-center, randomized, and controlled study.Frontiers in oncology · 2025Article
- Targeting the tumor microenvironment in cholangiocarcinoma to improve immune checkpoint blockade: potential strategies and translational pre-clinical models.Clinical & translational immunology · 2025Review
Corrections and comments
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Authors and funding
13 authors at 10 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAgents targeting the programmed cell death-1 pathway have demonstrated encouraging activity across multiple solid tumor types. The dose expansion phase of this phase I study evaluated the safety, tolerability, and antitumor activity of durvalumab monotherapy, and durvalumab plus tremelimumab (an anti-cytotoxic T-lymphocyte-associated antigen 4 monoclonal antibody) combination therapy, in patients from Asia with biliary tract cancer (BTC), esophageal squamous cell carcinoma (ESCC), or head and neck squamous cell carcinoma (HNSCC).
methodsPatients with advanced BTC, ESCC, or HNSCC with disease progression during or following ≥1 platinum-based therapy received durvalumab monotherapy (10 mg/kg every 2 weeks) or durvalumab plus tremelimumab (durvalumab 20 mg/kg every 4 weeks [Q4W] plus tremelimumab 1 mg/kg Q4W for 4 doses, followed by durvalumab 20 mg/kg Q4W). The primary objective was safety and tolerability. Secondary objectives included antitumor activity.
resultsDurvalumab monotherapy was assessed in 116 patients (median age 63.5 years, 75.9% male) of whom, 42, 42, and 32 had BTC, ESCC, or HNSCC, respectively. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 19.0%, 9.5%, and 25.0% of patients with BTC, ESCC, and HNSCC, respectively. Objective response rate (ORR) was 4.8%, 7.1%, and 9.4% in BTC, ESCC, and HNSCC. Durvalumab plus tremelimumab was evaluated in 124 patients (median age 62.0 years, 79.8% male) of whom 65 had BTC and 59 had ESCC. Grade ≥3 TRAEs were reported in 23.1% and 13.6% of patients with BTC and ESCC. ORR was 10.8% and 20.3% in BTC and ESCC. There were two complete responses and 10 partial responses in ESCC, and seven partial responses in BTC.
conclusionIn general, durvalumab monotherapy and durvalumab plus tremelimumab combination therapy displayed acceptable safety profiles consistent with published literature, and also demonstrated clinical benefit, in patients from Asia with BTC, ESCC, or HNSCC with disease progression on ≥1 prior treatment. CLINICALTRIALS: gov Identifier: NCT01938612.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.