Personalized Cancer Vaccine Evidence Tracker (2026)

Updated October 25, 2026. Personalized cancer vaccines are moving from experimental immunology into larger clinical trials, but the evidence is not equally strong across cancer types. A positive Phase 3 trial in melanoma, a promising small study in pancreatic cancer, and a discontinued colorectal cancer trial illustrate why each vaccine must be evaluated by its own clinical results.

This personalized cancer vaccine evidence tracker monitors major individualized neoantigen vaccine programs, including trial designs, clinical endpoints, biomarker findings, manufacturing feasibility, safety signals and unresolved questions. Its purpose is to distinguish evidence of an immune response from evidence that a treatment actually helps patients live longer or remain cancer-free.

Important distinction: A therapeutic cancer vaccine is given to someone who already has cancer, often after surgery when the amount of remaining disease may be very small. It is different from preventive vaccines such as HPV and hepatitis B vaccines, which reduce the risk of infections associated with certain cancers.

Key finding as of October 25, 2026: Merck and Moderna's individualized mRNA therapy, intismeran autogene (V940), has reported positive Phase 3 results in resected high-risk melanoma. Overall-survival benefit has not yet been established. Meanwhile, BioNTech and Genentech discontinued their Phase 2 autogene cevumeran trial in resected colorectal cancer following a futility assessment and a numerical imbalance in overall survival. These are different products, trials and treatment settings; neither result establishes a universal effect for personalized cancer vaccines.

Contents

• Executive summary
• What personalized cancer vaccines are
• Live evidence and trial tracker
• V940 Phase 3 melanoma results
• BNT122: pancreatic and colorectal cancer
• TG4050 and head and neck cancer
• The biomarker evidence matrix
• Manufacturing, access and real-world feasibility
• How we grade the evidence
• Funding, reporting and bias checklist
• How to find relevant clinical trials
• Questions to ask an oncologist
• Frequently asked questions
• Sources and further reading

1. Personalized cancer vaccine evidence: the current picture

Program	Cancer setting	Evidence status	Main interpretation
V940 / intismeran autogene	Resected high-risk melanoma	Positive Phase 3 RFS and DMFS results	Strongest randomized clinical evidence among the programs highlighted here; overall survival remains immature.
BNT122 / autogene cevumeran	Resected pancreatic ductal adenocarcinoma	Early Phase 1 evidence; Phase 2 randomized study ongoing	Promising vaccine-induced T-cell findings require confirmation in a randomized comparison.
BNT122 / autogene cevumeran	Resected, ctDNA-positive colorectal cancer	Phase 2 trial discontinued in August 2026	A significant negative development for this regimen and setting; the findings should not automatically be extrapolated to other cancers.
TG4050	Resected head and neck squamous cell carcinoma	Promising small randomized Phase 1 study; Phase 2 follow-up pending	Encouraging disease-free and immune-response signals, but the small study cannot establish efficacy definitively.

This tracker is a curated, actively maintained evidence watchlist, not a complete registry of every cancer vaccine trial worldwide. Results are classified by the specific product, cancer type, disease stage, treatment combination and study design.

2. What is a personalized cancer vaccine?

A personalized cancer vaccine is a treatment designed around characteristics of an individual patient's tumor. One important approach is an individualized neoantigen vaccine, which uses selected tumor mutations to help the immune system recognize cancer cells.

Unlike a conventional vaccine that targets the same antigen in many people, an individualized neoantigen vaccine may contain a different set of targets for each patient. The intended goal is to activate or expand T cells capable of recognizing cells that express those selected neoantigens.

How an individualized vaccine is developed

1. Tumor sampling: A tumor specimen is obtained, often during surgery. Blood or another normal-tissue sample may be used to help distinguish tumor mutations from inherited variants.
2. Genomic analysis: DNA sequencing identifies candidate somatic mutations. RNA and other data can help establish whether candidate targets are expressed.
3. Neoantigen selection: Computational prediction, including estimates of antigen processing and HLA presentation, helps prioritize candidates for the vaccine.
4. Vaccine manufacture: The selected sequences are incorporated into a platform such as mRNA, synthetic peptides or a viral vector.
5. Administration and immune monitoring: The vaccine is administered under a clinical protocol. Researchers can measure vaccine-specific T-cell responses and clinical outcomes.

This pipeline is scientifically plausible but does not guarantee that the vaccine will work. A predicted neoantigen may not be presented effectively by tumor cells, the patient's immune system may not mount a useful response, and cancer cells may evade immune recognition.

For a general explanation of cancer treatment vaccines, see the National Cancer Institute's overview of cancer treatment vaccines.

Why different vaccine platforms should not be treated as interchangeable

Platform	How it works	Key question
mRNA	Delivers instructions encoding selected neoantigens.	Does the vaccine generate durable, clinically useful immune responses?
Synthetic peptide	Delivers selected peptide targets, usually with immune-stimulating components.	Are the selected antigens presented effectively and recognized by relevant T cells?
Viral vector	Uses a modified virus to deliver genetic instructions for selected antigens.	Can the vector generate durable antitumor immunity with acceptable safety and feasible manufacturing?
Dendritic-cell approach	Uses antigen-presenting immune cells prepared or activated as part of a treatment.	Does the approach improve meaningful outcomes compared with appropriate standard care?

The evidence tracker concentrates on individualized or patient-specific neoantigen approaches. Shared-antigen vaccines and other therapeutic cancer immunotherapies should be tracked separately when their target-selection methods or mechanisms differ.

3. Personalized cancer vaccine evidence tracker: major programs

The table below separates published findings from sponsor announcements and ongoing clinical questions. A trial can produce a positive result for one endpoint while leaving overall survival, quality of life or long-term durability unresolved.

Vaccine / trial	Cancer and setting	Study design / status	Evidence to date	What remains unresolved
V940 / intismeran autogene INTerpath-001 NCT05933577	Completely resected high-risk stage IIB-IV cutaneous melanoma	Randomized, double-blind Phase 3; vaccine plus pembrolizumab versus placebo plus pembrolizumab.	Positive recurrence-free survival and distant metastasis-free survival results reported in 2026.	Mature overall survival, durability, regulatory decisions, cost and broader real-world applicability.
Autogene cevumeran / BNT122 Pancreatic Phase 1 NCT04161755	Resected pancreatic ductal adenocarcinoma	Early clinical study involving a vaccine, checkpoint inhibition and chemotherapy.	A 2025 Nature report found vaccine-induced T-cell responses in a subset of participants; immune responders had encouraging recurrence-free survival observations.	Whether the vaccine itself improves recurrence-free or overall survival compared with a suitable control group.
Autogene cevumeran / BNT122 Pancreatic Phase 2 NCT05968326	Resected pancreatic ductal adenocarcinoma	Randomized Phase 2 comparison of autogene cevumeran plus atezolizumab and modified FOLFIRINOX versus modified FOLFIRINOX alone. Recruitment was reported complete; the study remains active.	A randomized clinical test of the incremental benefit of the vaccine-containing regimen.	Comparative clinical efficacy, toxicity, recurrence outcomes and long-term survival.
Autogene cevumeran / BNT122 Colorectal Phase 2 NCT04486378	Resected, ctDNA-positive stage II high-risk or stage III colorectal cancer	Trial terminated in August 2026 following a data-monitoring recommendation.	Further continuation was considered unlikely to change the efficacy outcome. The monitoring committee identified a numerical overall-survival imbalance.	The full clinical context and detailed data underlying the imbalance. The finding must not be generalized to every individualized vaccine or every cancer type.
TG4050 NCT04183166	Resected, locally advanced HPV-negative head and neck squamous cell carcinoma	Randomized Phase 1 study with a subsequent Phase 2 component.	Small Phase 1 results published in Nature Communications in August 2026 showed persistent immune responses and an encouraging recurrence pattern.	Confirmation in the larger randomized Phase 2 cohort, including prespecified disease-free survival results.

Important: The Phase 1 and Phase 2 pancreatic studies are different trials. Early findings from NCT04161755 should not be presented as if they were the efficacy results of the randomized NCT05968326 study.

4. V940 cancer vaccine: what the Phase 3 melanoma results actually show

On August 19, 2026, Merck and Moderna announced positive topline results from INTerpath-001. More detailed findings were presented at the 2026 European Society for Medical Oncology (ESMO) Congress and reported on October 24, 2026.

Intismeran autogene, previously known as V940 or mRNA-4157, is an investigational individualized mRNA-based neoantigen therapy. It is designed using mutations identified in an individual patient's tumor and is being studied in combination with pembrolizumab, an anti-PD-1 checkpoint inhibitor.

The central clinical question is whether adding the personalized vaccine to pembrolizumab can improve outcomes beyond pembrolizumab alone after complete surgical removal of high-risk melanoma.

INTerpath-001: key numbers

Measure	V940 + pembrolizumab	Placebo + pembrolizumab
Participants in randomized groups	757	380
Median follow-up	24.6 months
Estimated 24-month recurrence-free survival	82.2%	70.0%
Estimated 24-month distant metastasis-free survival	88.5%	80.2%
Hazard ratio for recurrence or death	0.58 (95% CI 0.45-0.75; P less than 0.001)
Hazard ratio for distant metastasis or death	0.62 (95% CI 0.45-0.85; P = 0.002)
Overall survival	Immature; a statistically significant survival benefit has not been established.

Sources: Moderna's detailed results recap and the 2026 ESMO data summary.

How should the 42% reduction be interpreted?

The reported hazard ratio of 0.58 corresponds to a 42% relative reduction in the hazard of recurrence or death during the analyzed follow-up. It does not mean that 42% of patients were cured, that every individual receives the same benefit, or that the probability of recurrence fell by exactly 42 percentage points.

The estimated two-year recurrence-free survival rates were 82.2% with the combination and 70.0% with pembrolizumab alone, a difference of 12.2 percentage points. These are time-to-event estimates, not proof that the vaccine permanently prevents recurrence in those patients.

For distant metastasis-free survival, the corresponding estimates were 88.5% and 80.2%, a difference of 8.3 percentage points.

What about overall survival?

Overall survival is a separate endpoint. At the reported analysis, the overall-survival hazard ratio was 0.77 (95% CI 0.45-1.31; P = 0.33). The confidence interval includes no effect, and the data were immature. The trial has not yet established that the vaccine combination helps patients live longer.

This distinction matters because delaying recurrence, preventing distant metastases and extending life are related but different outcomes. Longer follow-up is needed to understand the magnitude and durability of any survival benefit.

What is known about safety?

The reported safety findings were broadly consistent with the known profiles of the treatments. Grade 3-5 treatment-related adverse events occurred in 14.2% of participants receiving the combination and 13.4% receiving pembrolizumab alone. Fever, injection-site pain and fatigue were among the commonly reported adverse events in the combination group.

These results do not establish that every patient will tolerate treatment similarly. Individual risks depend on medical history, concurrent treatment and other clinical factors.

What happens next for V940?

Merck and Moderna have said they intend to engage regulators regarding submissions. As of October 25, 2026, the results should not be interpreted as proof that V940 is already approved for routine melanoma treatment in a given country.

Tracker assessment: Positive Phase 3 evidence for recurrence-free and distant metastasis-free survival in the studied melanoma setting. Overall survival, regulatory status and the applicability of the results to other malignancies remain important open questions.

Primary sources: Merck's Phase 3 announcement and ClinicalTrials.gov record NCT05933577.

5. BNT122: pancreatic cancer promise and colorectal cancer setback

Autogene cevumeran, also known as BNT122 or RO7198457, is an individualized mRNA-based cancer immunotherapy developed by BioNTech and Genentech. Its recent clinical history illustrates why results must be interpreted according to the specific cancer, trial design and treatment combination.

Pancreatic cancer: encouraging but early evidence

Pancreatic ductal adenocarcinoma is a difficult disease in which recurrence after surgery remains a major concern. A personalized neoantigen vaccine is intended to stimulate T cells against tumor-specific mutations that may remain relevant after the visible tumor has been removed.

A Phase 1 study evaluated an approach combining surgery, atezolizumab, autogene cevumeran and modified FOLFIRINOX chemotherapy. In a 2025 Nature report with a median follow-up of 3.2 years, eight patients who developed vaccine-induced T-cell responses had a median recurrence-free survival that had not been reached, compared with 13.4 months among eight patients without those responses. The reported comparison had a P value of 0.007.

These observations are biologically encouraging, but they should not be mistaken for a randomized estimate of vaccine efficacy. The comparison was between patients who did and did not develop an immune response within a small early-stage study, not between randomly assigned groups differing only in vaccine exposure. Response status may be associated with other features of a patient's cancer or immune system.

Read the original research: RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer, Nature, February 19, 2025.

The randomized pancreatic Phase 2 trial

The next important question is whether the vaccine-containing regimen can improve outcomes compared with a control regimen. The randomized Phase 2 trial NCT05968326 compares autogene cevumeran plus atezolizumab and modified FOLFIRINOX with modified FOLFIRINOX alone in patients with resected pancreatic ductal adenocarcinoma.

The study has reported recruitment completion and remains active. Recruitment completion is not a clinical result: comparative recurrence-free survival, overall survival, adverse events and other prespecified endpoints must be evaluated when results become available.

Colorectal cancer: why the Phase 2 termination matters

On August 28, 2026, BioNTech announced that it would terminate the BNT122-01 Phase 2 trial in patients with circulating tumor DNA-positive, surgically resected stage II high-risk or stage III colorectal cancer.

The independent data safety monitoring board had previously concluded that the data were not sufficiently mature to support reliable efficacy conclusions. At its later review, the committee identified a numerical imbalance in overall survival between treatment arms and judged that continuing the trial was unlikely to change the efficacy outcome.

BioNTech reported that no new safety signals were identified by the committee. The company and its collaborator discontinued the trial after the monitoring recommendation.

This development should be reported carefully. A numerical overall-survival imbalance is an important finding that warrants attention, but the public announcement alone does not provide enough information to determine every possible cause of that imbalance or the size and precision of the treatment effect.

Equally important, the trial tested a specific personalized mRNA vaccine as adjuvant monotherapy in a specific colorectal cancer population. It does not prove that every mRNA vaccine is ineffective, that all neoantigen vaccines are harmful, or that the pancreatic cancer study has the same outcome.

Tracker assessment: The colorectal result is a major negative development for this regimen and indication. It reinforces the need for randomized controlled trials and for monitoring clinical outcomes rather than relying exclusively on immune-response biomarkers.

Sources: BioNTech's August 28, 2026 announcement and ClinicalTrials.gov NCT04486378.

6. TG4050: personalized cancer vaccination in head and neck cancer

TG4050 is an individualized neoantigen vaccine delivered using a modified vaccinia Ankara viral vector. It is being studied in people with locally advanced, resected HPV-negative head and neck squamous cell carcinoma.

In August 2026, Nature Communications published findings from a randomized Phase 1 study of adjuvant TG4050. The study compared immediate vaccination after standard adjuvant treatment with observation and an option to receive TG4050 after recurrence.

What did the small study find?

• Among 16 evaluable patients treated immediately with TG4050, no recurrence was observed at the primary analysis after a median follow-up of 30 months.
• Three of 16 patients in the observation group experienced recurrence during that follow-up period.
• Vaccine-specific T-cell responses were detected in 73.3% of evaluable immediately treated patients.
• An updated analysis at a median follow-up of 41 months reported no additional recurrences in either group.

These findings are encouraging, but the study was small and was primarily designed to assess safety, feasibility and immune responses rather than to establish efficacy definitively. No hazard ratio or P value establishing a disease-free survival benefit was reported in the publication summary.

The number of recurrence events was too small to support a reliable estimate of how much TG4050 changes recurrence risk. The result should therefore be considered a signal for further research, not proof that the vaccine prevents recurrence.

Why manufacturing is also part of the evidence

The researchers reported that vaccine manufacture was initiated for 76 patients and that vaccines were successfully manufactured for 53, with a median of 30 selected neoantigens per vaccine. Three eligible patients could not have a vaccine manufactured, while some patients experienced recurrence before they could receive treatment.

These details illustrate an underappreciated challenge. A therapy intended to eliminate microscopic residual disease after surgery may arrive too late if sequencing, target selection and manufacturing take too long, or if disease recurs before the vaccine can be administered.

The larger Phase 2 component of the study has progressed, with patient randomization completed in April 2026. Transgene has indicated that two-year disease-free survival results from evaluable Phase 2 patients are expected by the end of the first quarter of 2028.

Sources: Nature Communications, August 17, 2026 and Transgene's April 13, 2026 Phase 2 enrollment update.

7. The Cancer Vaccine × Biomarker × Outcome evidence matrix

A useful cancer vaccine evidence tracker should not merely list vaccine names and trial phases. It should connect each intervention to a measurable biological target, a biomarker result and a meaningful clinical outcome.

The central question is whether the vaccine produces an immune response that translates into better health outcomes—and whether the relevant biomarker can reliably identify the patients most likely to benefit.

Evidence layer	Measure	What it tells us	What it does not prove
1. Tumor genomics	Somatic mutations, tumor RNA expression, HLA genotype and selected neoantigens	Whether plausible tumor-specific targets can be identified.	That the selected target is processed and displayed effectively on cancer cells.
2. Vaccine manufacture	Successful manufacturing rate, turnaround time, dose delivery and treatment delays	Whether the individualized treatment can be produced and delivered in time.	Clinical efficacy after the vaccine is delivered.
3. Immune response	Neoantigen-specific CD4+ and CD8+ T cells, response breadth and persistence	Whether the immune system recognizes selected vaccine targets.	That cancer growth or recurrence is reduced.
4. Molecular residual disease	Circulating tumor DNA (ctDNA) after surgery or during follow-up	Whether tumor-derived DNA is detectable in blood using the particular assay.	That a negative test proves cure, or that a change in ctDNA necessarily predicts a survival benefit from vaccination.
5. Clinical benefit	Recurrence-free survival, disease-free survival, distant metastasis-free survival and overall survival	Whether patients experience meaningful differences in cancer outcomes.	That a treatment will work equally well for other cancer types, stages or treatment combinations.

ctDNA: a promising but easily misinterpreted biomarker

Circulating tumor DNA can help detect molecular residual disease after surgery and may identify patients at greater risk of recurrence. A personalized cancer vaccine may be tested in patients with detectable ctDNA because this can indicate that cancer-derived material remains in circulation despite no visible disease on imaging.

However, ctDNA is not interchangeable with a direct measurement of viable cancer cells. Test sensitivity varies, a negative result does not always exclude residual disease, and a reduction or disappearance of ctDNA should not automatically be interpreted as proof that a treatment improves survival.

For stronger evidence, researchers should prospectively define how ctDNA is measured, what constitutes clearance or recurrence, when blood is collected and how these findings relate to prespecified clinical endpoints.

What makes a biomarker clinically useful?

A biomarker is more compelling when it does more than correlate with outcomes. Researchers need to establish whether it predicts treatment benefit, whether the relationship is reproducible and whether decisions based on the marker improve patient outcomes.

For example, patients who develop vaccine-specific T cells may have different immune characteristics from those who do not. Comparing these groups is informative, but it cannot replace a randomized treatment comparison because immune response itself is not randomly assigned.

8. Manufacturing, personalization and real-world feasibility

Personalization creates both an opportunity and a logistical challenge. Each vaccine must be designed and produced for an individual patient, rather than drawn from a standard supply of identical doses.

A clinical evidence tracker should therefore collect manufacturing data alongside clinical results.

• Specimen adequacy: Was enough usable tumor tissue available for sequencing and target selection?
• Manufacturing success: Could the intended product be made for every eligible patient?
• Turnaround time: How long elapsed between surgery, sample collection, vaccine production and first administration?
• Time to recurrence: Did the patient remain eligible long enough to receive the vaccine?
• Dose delivery: How many patients received the planned number of doses?
• Access and cost: What infrastructure, logistics, reimbursement and clinical monitoring would be needed outside a trial?

These questions are particularly important in adjuvant treatment. When a vaccine is intended to target microscopic residual disease after surgery, an otherwise effective treatment may have limited practical value if it cannot be delivered before recurrence.

Manufacturing feasibility is not merely an operational metric. It can affect which patients enter the efficacy analysis, how many receive treatment and how broadly a trial's findings apply in routine care.

9. How SmartCancer grades personalized cancer vaccine evidence

Not all evidence should carry the same weight. The following grading system separates clinical outcomes from preliminary biological signals and is intended to make the tracker easier to interpret.

Grade	Evidence category	Interpretation
E5	Mature, replicated clinical benefit or strong confirmatory evidence	Evidence supports a durable clinical benefit for a defined population and treatment setting. Appropriate replication, follow-up and safety data are important.
E4	Strong randomized clinical evidence	A well-designed randomized trial demonstrates a meaningful benefit on a prespecified clinical endpoint, while longer-term outcomes or replication may remain outstanding.
E3	Early clinical efficacy signal	Small, early-phase or exploratory studies suggest benefit but do not provide reliable confirmation.
E2	Biological or biomarker evidence	The vaccine generates measurable immune responses or other biological changes, but meaningful clinical benefit is not established.
E1	Preclinical or mechanistic evidence	Evidence is based mainly on laboratory models, computational predictions or early experimental work.

These grades are an editorial framework for comparing evidence, not a formal regulatory classification or a substitute for a systematic review. A discontinued or negative trial should additionally receive an explicit negative-result flag, rather than being hidden by a single numerical grade.

Illustrative grading of the featured programs

• V940 in resected melanoma: E4 for the reported randomized Phase 3 recurrence-free and distant metastasis-free survival findings. Overall-survival benefit remains unproven, and this grade does not mean the product is approved.
• TG4050 in head and neck cancer: E3 for encouraging but small early clinical findings. The study is not sufficient to establish efficacy definitively.
• Autogene cevumeran in pancreatic cancer: E3 for exploratory Phase 1 clinical observations; vaccine-induced T-cell responses and associations with recurrence-free survival require randomized confirmation.
• Autogene cevumeran in colorectal cancer: Negative-result flag for the discontinued Phase 2 trial. The termination and reported overall-survival imbalance require transparent discussion, not omission from the evidence record.

For every entry, the tracker should record the evidence grade, confidence in the underlying data, study limitations and date last checked. Grades must be updated when full results, peer-reviewed publications or regulatory decisions become available.

10. Funding, reporting and bias: questions every evidence tracker should ask

Personalized cancer vaccines are a rapidly developing commercial field involving biotechnology companies, pharmaceutical partners, academic research groups, patent portfolios and substantial manufacturing infrastructure. Commercial participation does not invalidate results, but it makes transparent appraisal essential.

For every major announcement, SmartCancer should ask:

1. Who funded the trial? Record the sponsor, collaborating companies, academic centers and other material funding sources.
2. Is the finding topline or fully reported? A press release may summarize primary endpoints but omit important statistical, safety or subgroup details.
3. Was the endpoint prespecified? Distinguish the primary endpoint from exploratory analyses and post hoc findings.
4. Is the comparison randomized? A comparison between immune responders and nonresponders is not equivalent to a randomized comparison of treatment versus control.
5. How large and representative was the study? Check sample size, eligibility criteria, exclusions, follow-up and the number of outcome events.
6. What happened to all enrolled patients? Look for manufacturing failures, treatment delays, early recurrence, withdrawals and missing outcome data.
7. Are both relative and absolute outcomes available? Record hazard ratios with confidence intervals as well as event rates and survival estimates at meaningful time points.
8. Were unfavorable findings reported? Record trial closures, futility assessments, adverse events and negative endpoints alongside positive results.
9. Has the finding been independently reviewed? Separate sponsor announcements, conference abstracts, peer-reviewed articles and independent replication.
10. Does the claim match the evidence? Do not turn immune activation, a biomarker change or a preliminary recurrence signal into a claim of cure or proven survival extension.

A balanced evidence tracker should preserve negative and inconclusive findings. The purpose is to understand where individualized cancer vaccines may add value, where the evidence is still insufficient and where a particular approach has failed to demonstrate the intended benefit.

11. What would stronger evidence look like?

The next generation of trials should be judged not only by whether they activate the immune system, but by whether the clinical strategy improves outcomes in a defined patient population.

Priority 1: Randomized trials with appropriate control groups

Where feasible, the cleanest test of the incremental effect of a vaccine is a randomized trial that compares an otherwise similar treatment regimen with and without the vaccine. When several treatments differ between groups, interpretation becomes more complicated because the vaccine's contribution may be difficult to isolate.

Priority 2: Longer follow-up and clinically meaningful endpoints

In the adjuvant setting, recurrence-free or disease-free survival can provide important information. Overall survival, quality of life, treatment burden and long-term adverse effects remain relevant, particularly when patients may already have been cured by surgery and standard treatment.

Priority 3: Prospective biomarker validation

ctDNA, neoantigen-specific T-cell responses and other immune markers may help researchers understand how treatment works and which patients benefit. Their role as predictive or surrogate biomarkers needs to be established for the relevant cancer and treatment context, rather than assumed from biological plausibility alone.

Priority 4: Real-world manufacturing and access

A clinically effective vaccine must also be producible and deliverable on a timetable that suits the patient. Manufacturing success rates, turnaround times, treatment completion and the proportion of eligible patients who receive the intended therapy should be reported alongside clinical outcomes.

Priority 5: Negative-result transparency

Complete disclosure of failed endpoints, futility decisions, discontinuations and safety findings helps investigators refine target selection, patient selection, treatment timing and combination strategies. Negative trials are part of the evidence base, not exceptions to it.

12. How to find personalized cancer vaccine clinical trials

Patients and caregivers interested in research should begin with official trial registries and discuss eligibility with their oncology team. Eligibility depends on cancer type, stage, previous treatments, performance status, organ function, tissue availability and trial-specific rules.

Useful starting points include:

• ClinicalTrials.gov — search by cancer type, vaccine name, trial identifier and recruiting status.
• National Cancer Institute clinical trial information — information about participating in cancer research.
• NCI trials using intismeran autogene — a starting point for finding studies of V940.
• NCT05968326 — randomized Phase 2 study of autogene cevumeran-containing treatment after pancreatic cancer resection.
• NCT04183166 — TG4050 study in resected head and neck cancer.

Verify recruitment status directly. Trial registries can change, and a study described as recruiting at one point may later close enrollment. A trial's presence in a registry does not mean that the treatment is approved, that the treatment will benefit a particular patient or that a suitable site is available nearby.

13. Questions patients should ask their oncologist

For someone considering a personalized cancer vaccine trial, useful questions include:

• Is this vaccine being tested for my exact cancer type, stage and treatment setting?
• Is the vaccine experimental, and what standard treatment would I otherwise receive?
• Is the trial randomized, and what is the control group?
• What are the primary endpoint and the most recent clinical results?
• How long could sequencing and manufacture take, and what happens if my cancer recurs while I wait?
• What additional risks or burdens might arise from combining the vaccine with immunotherapy or chemotherapy?
• How will immune response, ctDNA and clinical outcomes be measured?
• What costs, travel requirements and follow-up visits might be involved?

A decision to join a clinical trial should be made with qualified clinicians who understand the patient's complete medical history and treatment options. No patient should delay or replace established cancer treatment on the assumption that a personalized vaccine will be available or effective.

14. Frequently asked questions

What is a personalized cancer vaccine evidence tracker?

It is a structured record of individualized cancer vaccine studies that monitors clinical trial status, cancer type, treatment regimen, biomarkers, endpoints, safety, manufacturing feasibility and published results. It helps distinguish strong clinical evidence from preliminary immune-response findings.

Are personalized cancer vaccines proven to cure cancer?

No. Clinical evidence varies by vaccine and cancer type. V940 has reported positive Phase 3 recurrence-free and distant metastasis-free survival results in resected high-risk melanoma, but a statistically significant overall-survival benefit has not yet been established in that trial. Other individualized vaccine programs remain at earlier stages or have had disappointing results.

What is the most advanced personalized mRNA cancer vaccine?

V940, also known as intismeran autogene or mRNA-4157, has reported positive Phase 3 results in combination with pembrolizumab for resected high-risk melanoma. Its results should be interpreted for that specific population and treatment setting; the evidence does not establish equivalent benefit across different cancers.

What happened to BioNTech's personalized colorectal cancer vaccine trial?

BioNTech announced on August 28, 2026, that it would terminate the Phase 2 BNT122-01 trial in resected, ctDNA-positive colorectal cancer after a monitoring committee concluded that continuing the trial was unlikely to change the efficacy outcome. The committee noted a numerical imbalance in overall survival and no new safety signals. The announcement should not be generalized to every personalized cancer vaccine program.

Can ctDNA prove that a personalized cancer vaccine is working?

Not by itself. ctDNA can provide information about molecular residual disease, but its meaning depends on the assay, timing, cancer type and clinical context. A change in ctDNA is not automatically proof that vaccination improves recurrence-free or overall survival.

Why are immune-response results insufficient on their own?

A vaccine may activate T cells without producing a meaningful improvement in cancer outcomes. To establish clinical benefit, studies should evaluate prespecified endpoints such as recurrence-free survival, disease-free survival, distant metastasis-free survival or overall survival, with appropriate comparisons and follow-up.

Are personalized cancer vaccines approved for routine treatment?

Regulatory status depends on the product, indication and jurisdiction. The featured investigational neoantigen programs should not be assumed to be approved routine treatments as of October 25, 2026. Check the relevant national regulator and consult the treating oncologist before making treatment decisions.

How can I find a clinical trial?

Search ClinicalTrials.gov or the National Cancer Institute's clinical trial resources. Review the eligibility criteria and confirm the latest recruiting status with the study team. An oncologist can help determine whether participation is appropriate.

15. Sources and further reading

The following sources form the core evidence base for this tracker. Primary trial records, peer-reviewed papers and official sponsor announcements should be prioritized when updating individual entries.

1. Merck and Moderna. Phase 3 INTerpath-001 topline results for intismeran autogene plus pembrolizumab in resected melanoma, August 19, 2026.
   Read the announcement.
2. Moderna. Detailed recap of INTerpath-001 Phase 3 findings, October 24, 2026.
   Read the results recap.
3. ClinicalTrials.gov. INTerpath-001, V940 plus pembrolizumab versus pembrolizumab alone in high-risk melanoma.
   NCT05933577.
4. BioNTech. Update and termination of the Phase 2 autogene cevumeran trial in resected colorectal cancer, August 28, 2026.
   Read the statement.
5. Sethna Z, et al. RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer. Nature. Published February 19, 2025.
   Read the original research.
6. ClinicalTrials.gov. Randomized Phase 2 study of autogene cevumeran plus atezolizumab and modified FOLFIRINOX versus modified FOLFIRINOX alone after pancreatic cancer resection.
   NCT05968326.
7. Nature Communications. A viral-based individualized neoantigen vaccine as adjuvant treatment in resected head and neck squamous cell carcinoma: a randomized Phase 1 trial. Published August 17, 2026.
   Read the original research.
8. Transgene. Completion of patient randomization in the Phase 2 part of the TG4050 clinical trial, April 13, 2026.
   Read the update.
9. National Cancer Institute. Cancer treatment vaccines.
   Read the overview.

Conclusion: track the outcome, not just the technology

Personalized cancer vaccines represent a promising direction in precision oncology, but they should be judged by the strength and relevance of their clinical evidence—not by the novelty of the platform or the excitement surrounding a press release.

The V940 results in resected melanoma represent an important positive Phase 3 milestone for individualized neoantigen therapy. Early pancreatic cancer findings suggest that vaccine-induced T-cell responses deserve further investigation, while the discontinued colorectal cancer trial demonstrates why all outcomes, including unfavorable ones, must remain visible.

For SmartCancer, the most valuable long-term resource is a continuously updated evidence system that connects cancer type → vaccine → biomarker → treatment setting → clinical outcome → evidence quality. That structure helps patients, clinicians and researchers see not only what appears promising, but also what has actually been demonstrated, what remains uncertain and which results could change clinical practice.

Medical disclaimer: This article is for education and research tracking only. It is not individualized medical advice and does not recommend replacing, delaying or discontinuing established cancer treatment. Personalized cancer vaccines discussed here may be investigational. Consult a qualified oncology team regarding treatment options and clinical trial participation.