Questions to Bring to Your Oncology Team
Personalized neoantigen vaccines are investigational immunotherapies designed from sequencing data from an individual patient's tumor. Products, evidence, trial criteria, and expanded-access pathways differ by cancer setting and sponsor.
FDA Expanded Access is a potential pathway to an investigational product outside a clinical trial in some circumstances. It is not approval and does not guarantee access. A treating physician, sponsor or manufacturer, institutional review board, FDA review, informed consent, medical eligibility, timing, and cost can all matter.
This page helps you organize questions for an oncology appointment. It does not calculate, predict, or determine eligibility, and it does not ask for, store, or send your medical details.
Medical Disclaimer: This tool does not provide medical advice, diagnosis, treatment recommendations, or eligibility decisions. Do not delay or change care based on it. Ask your oncologist and the relevant trial or expanded-access program about current criteria.
Bring these questions
A non-scoring checklist for an oncology appointment
You do not need to enter medical details here. Copy or print the questions that are useful. A treating oncology team and the relevant trial or program must interpret the answers.
- 1. Evidence: Which personalized neoantigen vaccine evidence, if any, applies to this exact cancer type, stage, and treatment setting?
- 2. Trials: Is there a suitable clinical trial, and what are its current status, location, eligibility criteria, and covered expenses?
- 3. Tissue and sequencing: Which tissue and sequencing results already exist, and are they sufficient for the specific trial or program?
- 4. Expanded access: If expanded access is being considered, who would serve as treating physician and sponsor, and are the manufacturer, IRB, and FDA pathway available?
- 5. Timing: How could disease changes, current treatment, design, manufacturing, and travel affect whether the pathway remains medically appropriate?
- 6. Risks and uncertainty: What is known about safety and possible benefit for this specific product and setting, and what remains unknown?
- 7. Costs: Which charges, ordinary clinical costs, travel expenses, stage payments, coverage decisions, and refund terms should be confirmed in writing?
Important: Do not delay or change treatment while researching. Expanded access is a potential pathway, not guaranteed access, and an investigational product may not help and may cause serious side effects.