Table 2.
Recent clinical trials combining neoantigen vaccines with immune checkpoint inhibitors.
| ClinicalTrial.gov identifier | Phase | Enrollment status | Cancer Type | Neoantigen Formulation | Additional intervention | Delivery | Dose and Schedule |
|---|---|---|---|---|---|---|---|
| NCT04397003 | II | Not yet recruiting | ES-SCLC | Neoantigen DNA | Anti-PD-L1(durvalumabMEDI4736) | Intramuscular by electroporation | Not specified, six q4w cycles |
| NCT03897881 | II | Recruiting | M | Neoantigen mRNA-4157 | Anti-PD-1(pembrolizumab) | None | 1,000 mg nine q3w cycles |
| NCT04267237 | II | Withdrawn | NSCLC | Neoantigen mRNA(RO7198457) | Anti- PD-L1(atezolizumab) | Intravenous infusion | Not specified, 12 q4w cycles |
| NCT03815058 | II | Recruiting | Advanced M | Neoantigen mRNA(RO7198457) | Anti-PD-1(pembrolizumab) | None | Not specified; qw priming and booster |
| NCT03606967 | II | Recruiting | Metastatic TNBC | poly-ICLC+ Neoanitgen synthetic long peptides | Anti-PD-L1 (durvalumabMEDI4736) | Subcutaneous | None |
| NCT03598816 | II | Withdrawn | RCC | Neoantigen DNA | anti-PD-L1 (durvalumab]) anti-CTLA-4 (tremelimumab) | Intramuscular | six doses |
| NCT03953235 | I, II | Recruiting | NSCLC, CRC, PC, other solid tumors | Neoantigen Peptides (GRT-C903 and GRT-R904) | anti-PD-1(Nivolumab)and anti-CTLA-4(ipilimumab) | None | None |
| NCT03639714 | I, II | Recruiting | NSCLC, MSSCRC, EC, BC | Neoantigen adenovirus vector + self-amplifying mRNA(GRT-C901 and GRT-R902) | anti-PD-1(nivolumab) and anti-CTLA-4(ipilimumab) | Intramuscular via viral vector | 30–300 mg, Priming and booster |
| NCT04251117 | I/IIA | Recruiting | HCC | Neoantigen DNA vaccine (GNOS-PV02) | Anti-PD-1(pembrolizumabMK-3475) | Intradermal injection and electroporation | None |
| NCT03164772 | I, II | Active, not recruiting | NSCLC | mRNA Vaccine (BI 1361849, CV9202) | anti-PD-L1 (durvalumab) + anti-CTLA-4 (tremelimumab) | None | None |
| NCT04024878 | I | Recruiting | OC | Poly-ICLC+Neoantigen peptide (NeoVax) | Anti-PD-1(nivolumab) | Injection underneath the skin | Not specified; priming and booster |
| NCT02897765 | I | Completed | UBC, BT, T CCB,MM, M,SC, NSCL | Neoantigen peptides(NEO-PV-01) | Anti-PD-1(nivolumab) | Subcutaneous | Not specified |
| NCT03289962 | I | Recruiting | Solid Cancers | Neoantigen mRNA (RO7198457) | Anti-PD-L1(atezolizumab) | Intravenous infusion RNA-lipoplex, | 25–100 mg qw priming and boosters |
| NCT03568058 | I | Active, not recruiting | Advanced Cancer | Neoantigen peptide | Anti-PD-1(pembrolizumab) | None | None |
| NCT04266730 | I | Not yet recruiting | NSCLC,SCCHN | Neoantigen peptide vaccine (PANDA-VAC) + Poly-ICLC | Anti-PD-1(pembrolizumab) | Subcutaneous | 1,800 ug, 2,400 ug, priming and booster |
| NCT04161755 | I | Recruiting | PC | Neoantigen mRNA(RO7198457) | Anti-PD-L1(atezolizumab) | None | None |
| NCT04072900 | I | Recruiting | M (Skin) | Neoantigen peptide | Anti-PD-1(toripalimab) | None | 4 × 3 mg all the peptides given by seven times |
| NCT03597282 | I | terminated | Metastatic M | Poly-ICLC + neoantigen peptides(NEO-PV-01) | Anti-PD-1(nivolumab), | Subcutaneous | None |
| NCT02287428 | I | Recruiting | GB | Neoanitgen peptide(NeoVax) | Anti-PD-1(pembrolizumab) | None | Not specific, priming and boost phases. |
| NCT04799431 | I | Not yet recruiting | PC,MCRC | Neoantigen Vaccine + Poly-ICLC | Anti-PD-1(retifanlimab) | Subcutaneous | 0.3 mg per peptide vaccine |
| NCT04248569 | I | Recruiting | FLC | Neoanitgen peptide(DNAJB1-PRKACA fusion kinase) | Anti-PD-1(nivolumab)and anti-CTLA-4(ipilimumab) |
None | Not specifically, Priming and booster |
| NCT03219450 | I | Not yet recruiting | LL | Neoanitgen peptide(NeoVax)+ Poly-ICLC | Anti-PD-1(pembrolizumab) | None | Not specifically, priming and booster |
| NCT03121677 | I | Recruiting | FL | Personalized tumor vaccine+ Poly-ICLC | Anti-PD-1(Nivolumab) | Subcutaneous | Not specifically |
| NCT03166254 | I | Withdrawn | NSCLC | Neoantigen peptides(NEO-PV-01)+ Poly-ICLC | Anti-PD-1(pembrolizumab) | None | Not specifically, priming and booster |
| NCT03199040 | I | Recruiting | TNBC | Neoantigen DNA | Anti-PD-L1 (durvalumab) | None | None |
| NCT03532217 | I | Active, not recruiting | MHSPC | Neoantigen DNA | Anti-PD-1(nivolumab)and anti-CTLA-4(ipilimumab) | Intramuscular | 4 mg, priming and booster |
| NCT03380871 | I b | Completed | Advanced or metastatic NSCLC | Neoantigen peptides(NEO-PV-01)+ Poly-ICLC | Anti-PD-1(pembrolizumab) | Subcutaneous | None |
| NCT02950766 | I | Recruiting | High-risk RCC | Neoanitgen peptide(NeoVax)+ Poly-ICLC | Anti-CTLA-4(ipilimumab) | Subcutaneous | Not specifically, priming and booster |
| NCT03359239 | I | Recruiting | UC/BC | Neoanitgen peptide (PGV001) + Poly-ICLC | Anti-PD-L1(atezolizumab) | None | Up to ten synthetic peptides—100 μg (0.01 ml, 10 mg/ml) per peptide. One tetanus helper peptide—100 μg (0.01 ml, 10 mg/ml),up to ten total doses |
| NCT03422094 | I | Terminated | GBM | Neoanitgen peptide(NeoVax)+ Poly-ICLC | Anti-PD-1(nivolumab)and anti-CTLA-4(ipilimumab) | Subcutaneous | Not specifically, priming and booster |
| NCT03929029 | Ib | Recruiting | M | Neoanitgen peptide(NeoVax)+ Poly-ICLC+ Montanide | Anti-PD-1(nivolumab)and anti-CTLA-4(ipilimumab) | None | None |
| NCT04117087 | I | Recruiting | CRC, PC | KRAS peptide+ Poly-ICLC | Anti-PD-1(nivolumab)and anti-CTLA-4(ipilimumab) | None | 1.8 mg, priming and booster |
ES-SCLC, extensive stage small cell lung cancer; NSCLC, non-small cell lung cancer; MCRC, metastatic colorectal cancer; CRC, colorectal cancer; MSSCR, microsatellite state colorectal cancer; UBC, urinary bladder Cancer; UC/BC, urinary/bladder carcinoma; BT, bladder tumors; TCCB, transitional cell carcinoma of the bladder; MM, malignant melanoma; M, melanoma; SC, skin cancer; SCCHN, squamous cell carcinoma of head and neck; HCC, hepatic cell cancer; TNBC, triple negative breast neoplasms; RCC, renal cell carcinoma; LL, lymphocytic leukemia; FL, follicular lymphoma; PC, pancreatic carcinoma; MHSPC, metastatic hormone-sensitive prostate cancer; FLC, fibrolamellar hepatocellular carcinoma; OC, ovarian cancer; GBM, glioblastoma; Poly-ICLC, polyinosinic–polycytidylic acid-poly-l-lysine carboxymethylcellulose.