ArticleClinical cancer research : an official journal of the American Association for Cancer Research2017
Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 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
30 citing papers in PubMed.
- Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: CheckMate 153.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Association of BRAF V600E/K Mutation Status and Prior BRAF/MEK Inhibition With Pembrolizumab Outcomes in Advanced Melanoma: Pooled Analysis of 3 Clinical Trials.JAMA oncology · 2020Trial
- Equivalence of neoadjuvant and perioperative therapies in patients with stage III non-small cell lung cancer: a systematic review and meta-analysis.Journal of thoracic disease · 2026Article
- PD-1/PD-L1 blockade in HIV-associated advanced lung cancer: from mechanisms to clinical practice.Frontiers in immunology · 2026Review
- Application of extended immunotherapy in advanced clear cell renal cell carcinoma treated with first-line combination of immune-checkpoint inhibitor and tyrosine kinase inhibitor.International urology and nephrology · 2025Article
- Adverse event profile of five anti head and neck squamous cell carcinoma drugs: a descriptive analysis from WHO-VigiAccess.Frontiers in pharmacology · 2025Article
- Non-Viral Systems Based on PAMAM-Calix-Dendrimers for Regulatory siRNA Delivery into Cancer Cells.International journal of molecular sciences · 2024Article
- Pembrolizumab-induced myocarditis with complete atrioventricular block and concomitant myositis in a metastatic bladder cancer patient: a case report and review of the literature.Journal of medical case reports · 2024Review
- Deterioration in multifocal motor neuropathy upon treatment of immune-related adverse events of checkpoint inhibition.Immunotherapy · 2024Article
- Article
- Closing the gaps in recruitment and retention in cancer trials: sufficient evidence but poor implementation.BMJ oncology · 2023Article
- Pre-Existing Autoimmune Disease and Mortality in Patients Treated with Anti-PD-1 and Anti-PD-L1 Therapy.Journal of the National Cancer Institute · 2022Article
- The Association between Early Changes in Neutrophil-Lymphocyte Ratio and Survival in Patients Treated with Immunotherapy.Journal of clinical medicine · 2022Article
- Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma.CPT: pharmacometrics & systems pharmacology · 2022Article
- Immuno-oncology trends: preclinical models, biomarkers, and clinical development.Journal for immunotherapy of cancer · 2022Review
- Dendritic cell targeting with Fc-enhanced CD40 antibody agonists induces durable antitumor immunity in humanized mouse models of bladder cancer.Science translational medicine · 2021Article
- Low-dose ipilimumab plus nivolumab combined with IL-2 and hyperthermia in cancer patients with advanced disease: exploratory findings of a case series of 131 stage IV cancers - a retrospective study of a single institution.Cancer immunology, immunotherapy : CII · 2021Article
- Lights and Shadows in Immuno-Oncology Drug Development.Cancers · 2021Article
- Characterizing tumor shrinkage as a measure of clinical benefit for immune checkpoint inhibitors.Journal for immunotherapy of cancer · 2021Article
- A Novel Mice Model for Studying the Efficacy and IRAEs of Anti-CTLA4 Targeted Immunotherapy.Frontiers in oncology · 2021Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
Recent advances in immuno-oncology and regulatory approvals have been rapid and paradigm shifting in many difficult-to-treat malignancies. Despite immune checkpoint inhibitor therapy becoming the standard of care across multiple tumor types, there are many unanswered questions that need to be addressed before this therapeutic modality can be fully harnessed. Areas of limitations include treatment of patients not sufficiently represented in clinical trials, uncertainty of the optimal treatment dosing and duration, and lack of understanding regarding long-term immune related toxicities and atypical tumor responses. Patients such as those with autoimmune disease, chronic viral infections, limited performance status, and brain metastases were often excluded from initial trials due to concerns of safety. However, limited data suggest that some of these patients can benefit from therapy with manageable toxicities; thus, future studies should incorporate these patients to clearly define safety and efficacy. There are still controversies regarding the optimal dosing strategy that can vary from weight-based to flat dosing, with undefined treatment duration. Further elucidation of the optimal dosing approach and evaluation of predictive biomarkers should be incorporated in the design of future trials. Finally, there are long-term immune-mediated toxicities, atypical tumor responses such as pseudoprogression and endpoints unique to immuno-oncology that are not adequately captured by traditional trial designs; thus, novel study designs are needed. In this article, we discuss in detail the above challenges and propose needed areas of research for exploration and incorporation in the next generation of immuno-oncology clinical trials.
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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.