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Last updated: July 20, 2026
A therapeutic cancer vaccine trains the patient's own immune system to recognize abnormal proteins on their tumor and generate T cells that hunt down cancer cells carrying them. Unlike a preventive vaccine, it's given to people who already have (or have had) cancer. The target proteins are tumor antigens; when they come from cancer-specific mutations they are called neoantigens. These vaccines are usually paired with an immune-checkpoint inhibitor (pembrolizumab, nivolumab, atezolizumab, tislelizumab) so the vaccine-primed T cells aren't switched off by the tumor.
Two approaches appear in this hub:
1. KRAS-specific ("off-the-shelf") vaccines target the mutant KRAS protein — a driver shared by many patients (common in pancreatic, colorectal, and lung cancer) — so the same vaccine works for anyone with that KRAS mutation. Examples: ELI-002 (amphiphile peptide vaccine), mutant-KRAS long-peptide vaccines, GVAX/mKRASvax. 2. Personalized (individualized) neoantigen vaccines are custom-built per patient — the tumor is sequenced, each person's unique neoantigens are identified, and a bespoke mRNA vaccine is manufactured, covering KRAS and many other mutations at once. Examples: autogene cevumeran (BNT122), intismeran autogene (V940 / mRNA-4157).
| Vaccine | Developer | Type | Status / Catalyst | Lead Recruiting Indications |
|---|---|---|---|---|
| Autogene cevumeran (BNT122, RO7198457) | BioNTech / Genentech | Personalized mRNA neoantigen | Investigational. 3-year follow-up in resected pancreatic cancer presented at AACR 2026 (RFS not reached in immune responders vs ~13 mo in non-responders). Randomized Phase 2. | Adjuvant resected pancreatic (Ph2), muscle-invasive bladder (Ph2) |
| Intismeran autogene (V940, mRNA-4157) | Moderna / Merck | Personalized mRNA neoantigen | FDA Breakthrough Therapy in melanoma (+ pembrolizumab, adjuvant). Multiple Phase 3 trials (melanoma, NSCLC). | Melanoma, NSCLC (Ph3), bladder/NMIBC (Ph2) |
| ELI-002 (7P / 2P) | Elicio Therapeutics | Off-the-shelf amphiphile KRAS vaccine | Investigational. Amphiphile lymph-node-targeted mutant-KRAS peptide vaccine + CpG adjuvant; AMPLIFY program. Phase 1 (7P version, ± tislelizumab). | Pancreatic (Ph1), KRAS-mutant solid tumors |
| Mutant-KRAS peptide vaccines (mKRASvax, long-peptide) | Academic (e.g., Johns Hopkins) + others | Off-the-shelf KRAS peptide | Investigational. Long-peptide and pooled mutant-KRAS vaccines, often with dual checkpoint blockade (nivolumab + ipilimumab; balstilimab + botensilimab). | Pancreatic (incl. high-risk/prevention), NSCLC, colorectal |
| GVAX (vs mKRASvax comparison) | Academic | Whole-cell (GM-CSF) vaccine | Investigational. Head-to-head neoadjuvant/adjuvant GVAX vs a mutant-KRAS vaccine, both with anti-PD-1 + anti-CTLA-4. | Pancreatic (Ph1/2) |
BioNTech and Genentech's individualized mRNA neoantigen vaccine (the same platform family as the COVID-19 mRNA vaccines, repurposed for cancer). Each patient's resected tumor is sequenced, their neoantigens are computationally selected, and a bespoke mRNA vaccine is manufactured. The headline setting is adjuvant therapy after surgery for resected pancreatic ductal adenocarcinoma — NCT05968326 (Phase 2, with atezolizumab and mFOLFIRINOX chemotherapy). At AACR 2026, updated 3-year follow-up of the earlier Phase 1 showed that patients who mounted a vaccine-specific immune response had recurrence-free survival not reached, versus roughly 13 months for non-responders — an unusually durable signal in a cancer with very high recurrence. Also in Phase 2 for muscle-invasive bladder cancer (NCT06534983, with nivolumab). Not FDA-approved; investigational.
Moderna and Merck's individualized mRNA neoantigen vaccine, the most regulatorily-advanced in this class. It holds FDA Breakthrough Therapy Designation in melanoma (in combination with pembrolizumab, adjuvant setting) and is being tested across a broad Phase 3 program: melanoma and non-small cell lung cancer are the lead indications. Recruiting trials include NSCLC Phase 3 studies (NCT06077760, NCT06623422, adjuvant NCT07513376), melanoma Phase 2 (NCT06961006), squamous NSCLC (NCT07221474), and a bladder / non-muscle-invasive bladder cancer study with BCG (NCT06833073). Personalized, so it covers each patient's own neoantigen set (KRAS and beyond). Not FDA-approved; investigational.
Elicio Therapeutics' KRAS-directed vaccine using an "amphiphile" design that traffics the mutant-KRAS peptide antigens plus a CpG (TLR-9) adjuvant directly to the lymph nodes, where T-cell responses are generated. Unlike the personalized vaccines, ELI-002 is off-the-shelf — it targets shared mutant-KRAS peptides, so any patient with a covered KRAS mutation can receive it. The earlier AMPLIFY-201 Phase 1 (published in Nature Medicine) showed T-cell responses and delayed recurrence in high-risk pancreatic and colorectal patients after locoregional treatment. The current trial is the 7-peptide version, ELI-002 7P, with or without tislelizumab, in pancreatic cancer (NCT07671339, Phase 1). Not FDA-approved; investigational.
A cluster of academic and biotech KRAS peptide vaccines, mostly in pancreatic cancer and mostly combined with checkpoint blockade: a mutant-KRAS long-peptide vaccine for high-risk / pre-malignant and resected patients (NCT05013216); a pooled mutant-KRAS vaccine with chemoimmunotherapy + nivolumab and ipilimumab in NSCLC (NCT05254184); a KRAS-targeted vaccine with balstilimab and botensilimab in colorectal and pancreatic cancer (NCT06411691); and a head-to-head neoadjuvant/adjuvant GVAX vs mutant-KRAS vaccine, both with anti-PD-1 + anti-CTLA-4, in pancreatic cancer (NCT06782932). Additional KRAS-vaccine studies in KRAS-mutated malignancies (NCT07004244) and a not-yet-recruiting KRAS-specific vaccine in KRAS-mutant solid tumors (NCT07396090) round out the off-the-shelf group.
Trials are grouped by primary cancer type below. Many are adjuvant / post-resection studies (given after surgery to prevent recurrence, when there is no measurable disease) rather than advanced-disease trials — an important distinction when checking fit. Ask your oncologist for your KRAS mutation status and surgical history before screening.
~90% of pancreatic ductal adenocarcinomas carry a KRAS mutation, making it the leading target for these vaccines — concentrated in the adjuvant / resected / high-risk setting.
Showing selected trials from 24 recruiting + 2 not-yet-recruiting KRAS-mutant / neoantigen cancer-vaccine interventional trials in the ClinTrialFinder corpus as of July 20, 2026. Individualized "neoantigen vaccine" studies that do not specifically target KRAS are included where they represent the same personalized-vaccine modality. For the latest searches: autogene cevumeran, intismeran, ELI-002, KRAS vaccine.
KRAS-mutant cancer now has two very different targeted approaches, and they are not the same page in a patient's journey:
| Approach | How it works | Typical setting | FDA status |
|---|---|---|---|
| KRAS / neoantigen vaccines (this page) | Trains the immune system (T cells) to attack KRAS-mutant or neoantigen-bearing tumor cells | Often adjuvant / post-resection (prevent recurrence); no approved agent yet | None approved (investigational; V940 has Breakthrough in melanoma) |
| KRAS inhibitors (small molecules) | A drug directly blocks the mutant KRAS protein inside the cancer cell | Mostly advanced / metastatic disease | Sotorasib (Lumakras) & adagrasib (Krazati) FDA-approved for KRAS G12C; pan-RAS daraxonrasib in Phase 3 |
A resected KRAS-mutant patient with no measurable disease may be a candidate for a vaccine trial (to prevent recurrence), while a patient with advanced metastatic KRAS-mutant cancer is more likely to be considered for a KRAS inhibitor. Many patients ask about both — see the KRAS Inhibitors hub for the small-molecule side.
What is a therapeutic cancer vaccine?
A therapeutic cancer vaccine trains the patient's own immune system to recognize abnormal proteins in their tumor and generate T cells that attack cancer cells carrying them. Unlike a preventive vaccine, it's given to people who already have or have had cancer. The target proteins are tumor antigens; those from cancer-specific mutations are neoantigens. The vaccines here target either mutant KRAS (a shared driver) or a patient's individual neoantigens, and are usually combined with a checkpoint inhibitor (pembrolizumab, nivolumab, atezolizumab, or tislelizumab).
What's the difference between a KRAS-specific and a personalized neoantigen vaccine?
A KRAS-specific vaccine is "off the shelf" — it targets the mutant KRAS protein shared across many patients, so the same vaccine works for anyone with that mutation (e.g., ELI-002, mutant-KRAS peptide vaccines). A personalized (individualized) neoantigen vaccine is custom-made per patient: the tumor is sequenced, each person's unique neoantigens are identified, and a bespoke mRNA vaccine is manufactured — covering KRAS and many other mutations (e.g., autogene cevumeran / BNT122, intismeran / V940). Off-the-shelf is faster and cheaper; personalized covers more of each tumor but needs a per-patient manufacturing turnaround.
Is any cancer vaccine of this type FDA-approved?
No — as of July 2026, no therapeutic cancer vaccine targeting mutant KRAS or personalized neoantigens is FDA-approved; all are investigational. Intismeran autogene (V940 / mRNA-4157, Moderna/Merck) holds FDA Breakthrough Therapy Designation in melanoma (with pembrolizumab, adjuvant) and is in multiple Phase 3 trials. Autogene cevumeran (BNT122) reported encouraging 3-year follow-up in resected pancreatic cancer at AACR 2026 and is in randomized Phase 2. Regulatory status can change — check the FDA and trial sponsors.
Are there cancer vaccine trials for pancreatic cancer?
Yes — pancreatic cancer is the most active area, because ~90% of pancreatic ductal adenocarcinomas carry a KRAS mutation. Lead trials: adjuvant autogene cevumeran (BNT122) after surgery (the AACR 2026 trial); ELI-002 7P (amphiphile KRAS vaccine ± tislelizumab); mutant-KRAS long-peptide vaccines for high-risk/resected patients; and a GVAX-vs-mKRASvax comparison. Many enroll in the adjuvant / "no evidence of disease" setting after surgery to prevent recurrence — a different population from advanced disease. Confirm your KRAS status and surgical history with your oncologist.
How do I find a cancer vaccine trial that fits my situation?
Use ClinTrialFinder's AI-powered matching to surface cancer-vaccine trials based on your cancer type (pancreatic, NSCLC, melanoma, bladder, colorectal, or other), KRAS status if known, whether your tumor was surgically resected (many trials are adjuvant / post-resection), prior therapy, and country. Use the patient-match button below. Because these are early-phase investigational therapies, ask your oncologist whether a vaccine trial suits your setting, and verify eligibility and recruitment on ClinicalTrials.gov. See also /trials/pancreatic-cancer, /trials/lung-cancer-nsclc, /trials/melanoma, and the /mechanisms/kras-inhibitors hub.
Find Matching Cancer Vaccine Trials
Use ClinTrialFinder's AI-powered matching to find autogene cevumeran, intismeran (V940), ELI-002, and other KRAS-mutant / neoantigen vaccine trials based on your cancer type, KRAS status, surgical history, and country.
Find Matching Vaccine TrialsThis page is for information only and is not medical advice. ClinTrialFinder helps you find clinical trials that may match your situation, but enrollment and treatment decisions should always be made with your medical oncologist. Trial eligibility, recruitment status, and details can change — verify directly with the trial sponsor or on ClinicalTrials.gov before acting on any information here. Regulatory status is summarized for context only and can change; no KRAS-mutant / neoantigen cancer vaccine is FDA-approved as of July 2026. Consult the FDA and current prescribing information for authoritative status.