Trial reportContemporary clinical trials2015
A Phase I/II adaptive design to determine the optimal treatment regimen from a set of combination immunotherapies in high-risk melanoma.
Trial report in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.
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
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Pooled it
- 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
- Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- 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
- Practical implementation of the partial ordering continual reassessment method in a Phase I combination-schedule dose-finding trial.Statistics in medicine · 2022Article
- Adapting isotonic dose-finding to a dynamic set of drug combinations with application to a phase I leukemia trial.Clinical trials (London, England) · 2021Article
- Novel strategies in immune checkpoint inhibitor drug development: How far are we from the paradigm shift?British journal of clinical pharmacology · 2020Review
- 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
- A Bayesian design for phase I cancer therapeutic vaccine trials.Statistics in medicine · 2019Article
- Two-stage design for phase I-II cancer clinical trials using continuous dose combinations of cytotoxic agents.Journal of the Royal Statistical Society. Series C, Applied statistics · 2019Article
- 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
- Article
- Implementation of adaptive methods in early-phase clinical trials.Statistics in medicine · 2017Review
- Immuno-oncology combinations: raising the tail of the survival curve.Cancer biology & medicine · 2016Article
- Practical designs for Phase I combination studies in oncology.Journal of biopharmaceutical statistics · 2016Review
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
In oncology, vaccine-based immunotherapy often investigates regimens that demonstrate minimal toxicity overall and higher doses may not correlate with greater immune response. Rather than determining the maximum tolerated dose, the goal of the study becomes locating the optimal biological dose, which is defined as a safe dose demonstrating the greatest immunogenicity, based on some predefined measure of immune response. Incorporation of adjuvants, new or optimized peptide vaccines, and combining vaccines with immune modulators may enhance immune response, with the aim of improving clinical response. Innovative dose escalation strategies are needed to establish the safety and immunogenicity of new immunologic combinations. We describe the implementation of an adaptive design for identifying the optimal treatment strategy in a multi-site, FDA-approved, phase I/II trial of a novel vaccination approach using long-peptides plus TLR agonists for resected stage IIB-IV melanoma. Operating characteristics of the design are demonstrated under various possible true scenarios via simulation studies. Overall performance indicates that the design is a practical Phase I/II adaptive method for use with combined immunotherapy agents. The simulation results demonstrate the method's ability to effectively recommend optimal regimens in a high percentage of trials with manageable sample sizes. The numerical results presented in this work include the type of simulation information that aid review boards in understanding design performance, such as average sample size and frequency of early trial termination, which we hope will augment early-phase trial design in cancer immunotherapy.
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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.