Trial reportClinical and translational science2023
Exposure-response analysis for nivolumab plus ipilimumab combination therapy in patients with advanced hepatocellular carcinoma (CheckMate 040).
Trial report in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 13 citations in OpenAlex.
- Exposure-response relationship of nivolumab and ipilimumab in patients with metastatic renal cell carcinoma from the randomised phase 2 BIONIKK study.British journal of cancer · 2026Trial
- Exposure-response analysis for nivolumab plus ipilimumab combination therapy in patients with advanced hepatocellular carcinoma (CheckMate 040).Clinical and translational science · 2023Trial
- Exposure-Response Analyses of Datopotamab Deruxtecan (Dato-DXd), a TROP2-Directed Antibody-Drug Conjugate, in Advanced Non-small Cell Lung Cancer.Clinical pharmacology and therapeutics · 2026Article
- Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products.The oncologist · 2026Review
- Chinese Expert Consensus on the Whole-Course Management of Hepatocellular Carcinoma (2023 Edition).Liver cancer · 2025Review
- Effect of immune checkpoint inhibitors on patients with hepatitis B virus infection.Journal of the Chinese Medical Association : JCMA · 2025Review
- Immune-mediated liver injury from checkpoint inhibitors: mechanisms, clinical characteristics and management.Nature reviews. Gastroenterology & hepatology · 2025Review
- TSC/mTORC1 mediates mTORC2/AKT1 signaling in c-MYC-induced murine hepatocarcinogenesis via centromere protein M.The Journal of clinical investigation · 2024Article
- Nivolumab and Ipilimumab Acting as Tormentors of Advanced Tumors by Unleashing Immune Cells and Associated Collateral Damage.Pharmaceutics · 2024Review
- Overcoming Resistance to Immune Checkpoint Blockade in Liver Cancer with Combination Therapy: Stronger Together?Seminars in liver disease · 2024Review
- The AFCRPLITY score for predicting the prognosis of immunotherapy combined with local-regional therapy in unresectable hepatocellular carcinoma.Therapeutic advances in medical oncology · 2024Article
- Immune-Based Combination Therapies for Advanced Hepatocellular Carcinoma.Journal of hepatocellular carcinoma · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This analysis was conducted to inform dose selection of a combination of nivolumab plus ipilimumab for the treatment of sorafenib-experienced patients with hepatocellular carcinoma (HCC). CheckMate 040 is an open-label, multicohort, phase I/II trial in adults with advanced HCC that evaluated nivolumab monotherapy (0.1-10 mg/kg once every 2 weeks [q2w]) and the following three combinations of nivolumab plus ipilimumab: (1) nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks (q3w) for four doses, followed by nivolumab monotherapy 240 mg q2w (arm A); (2) nivolumab 3 mg/kg plus ipilimumab 1 mg/kg q3w for four doses, followed by nivolumab monotherapy 240 mg q2w (arm B); and (3) nivolumab 3 mg/kg q2w plus ipilimumab 1 mg/kg every 6 weeks continuously (arm C). Exposure-response relationships (efficacy and safety) were characterized using nivolumab and ipilimumab concentrations after the first dose (Cavg1) as the exposure measure. Objective tumor response (OTR) and overall survival (OS) improvements were associated with increased ipilimumab exposure (OTR: odds ratio 1.45, 95% confidence interval [CI], 1.13-1.86; OS: hazard ratio 0.86, 95% CI 0.75-0.98), but not nivolumab exposure (OTR: odds ratio 0.99, 95% CI 0.97-1.02; OS: hazard ratio 1.08, 95% CI 0.89-1.32). Hepatic treatment-related and immune-mediated adverse events were more common in arm A than in arms B or C. Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg q3w for four doses, followed by nivolumab monotherapy 240 mg q2w had the most favorable benefit:risk profile in patients with advanced HCC.
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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.