Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017
Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.
Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
17 citing papers in PubMed, 21 citations in OpenAlex.
- Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma.Journal for immunotherapy of cancer · 2021Trial
- Trial to evaluate the immunogenicity and safety of a melanoma helper peptide vaccine plus incomplete Freund's adjuvant, cyclophosphamide, and polyICLC (Mel63).Journal for immunotherapy of cancer · 2021Trial
- A narrative review of adaptive Phase I/II clinical trial designs for drug combinations in oncology.Frontiers in oncology · 2026Review
- crm12comb: Phase I/II adaptive design for drug combinations based on CRM design through R.PloS one · 2025Article
- Applications of the partial-order continual reassessment method in the early development of treatment combinations.Clinical trials (London, England) · 2024Article
- Operating characteristics are needed to properly evaluate the scientific validity of phase I protocols.Contemporary clinical trials · 2021Article
- Designing Dose-Finding Phase I Clinical Trials: Top 10 Questions That Should Be Discussed With Your Statistician.JCO precision oncology · 2021Article
- Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs.BMC medicine · 2020Article
- Flexible Phase I-II design for partially ordered regimens with application to therapeutic cancer vaccines.Statistics in biosciences · 2020Article
- Efficient dose-finding for drug combination studies involving a shift in study populations.Contemporary clinical trials communications · 2020Article
- Tailoring early-phase clinical trial design to address multiple research objectives.Cancer immunology, immunotherapy : CII · 2020Article
- Reprioritizing Risk and Benefit: The Future of Study Design in Early-Phase Cancer Research.Ethics & human research · 2019Article
- A Bayesian design for phase I cancer therapeutic vaccine trials.Statistics in medicine · 2019Article
- Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.Journal of the National Cancer Institute · 2019Review
- Revisiting isotonic phase I design in the era of model-assisted dose-finding.Clinical trials (London, England) · 2018Article
- Design considerations for early-phase clinical trials of immune-oncology agents.Journal for immunotherapy of cancer · 2018Article
- Implementation of a Model-Based Design in a Phase Ib Study of Combined Targeted Agents.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
Background: In recent years, investigators have asserted that the 3 + 3 design lacks flexibility, making its use in modern early-phase trial settings, such as combinations and/or biological agents, inefficient. More innovative approaches are required to address contemporary research questions, such as those posed in trials involving immunotherapies. Design: We describe the implementation of an adaptive design for identifying an optimal treatment regimen, defined by low toxicity and high immune response, in an early-phase trial of a melanoma helper peptide vaccine plus novel adjuvant combinations. Results: Operating characteristics demonstrate the ability of the method to effectively recommend optimal regimens in a high percentage of trials with reasonable sample sizes. Conclusions: The proposed design is a practical, early-phase, adaptive method for use with combined immunotherapy regimens. This design can be applied more broadly to early-phase combination studies, as it was used in an ongoing study of two small molecule inhibitors in relapsed/refractory mantle cell lymphoma.
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Identifiers
What OpenQuestion holds
Registered trials
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.