Table 2.
Ongoing clinical trials investigating peptide vaccines in cancer.
| Clinical Trial Identifier Code | Investigation Plan | Vaccines, Drug/s | Clinical Setting Lines of therapy | Primary Endpoint | Stage of Development | Clinical Trials Status |
|---|---|---|---|---|---|---|
| NCT01789099 | 18 participants, Single Group Assignment, Open Label |
UV1 synthetic peptide vaccine and GM-CSF | Second or later lines | Safety and tolerability, Immunological response | 1/2 | Active, not recruiting |
| NCT01784913 | 22 participants, Single Group Assignment, Open Label |
UV1/hTERT2012P | First line | Safety and tolerability | 1/2 | Active, not recruiting |
| NCT03012100 | 280 participants, Randomized, Parallel Assignment, Triple masking, Double Blind |
Cyclophosphamide, Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim |
Second or later lines | DFS | 2 | Recruiting |
| NCT01720836 | 30 participants, Non-Randomized, Parallel Assignment, Open Label |
Vaccine + PolyICLC | Second or later lines | Immunologic response | 1/2 | Recruiting |
| NCT00194714 | 26 participants, Single Group Assignment, Open Label |
HER-2/neu Peptide Vaccine | Second or later lines | Immunologic response, AE |
1/2 | Active, not recruiting |
| NCT03606967 | 70 participants, Randomized, Parallel Assignment, Open Label |
Carboplatin, Durvalumab, Gemcitabine Hydrochloride, Nab-paclitaxel, Personalized Synthetic Long Peptide Vaccine, Poly ICLC, Tremelimumab |
First line | Clinical response | 2 | Recruiting |
| NCT04998474 | 15 participants, Single Group Assignment, Open Label |
FRAME-001 personalized vaccine | Fourth or later lines | FRAME-001-specific immune responses | 2 | Not yet recruiting |
| NCT02795988 | 36 participants, Randomized, Parallel Assignment, Partially blinded (outcomes assessor) |
IMU-131, Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine. | First line | Safety and tolerability, Recommended Phase 2 dose and clinical efficacy of IMU-131 |
1/2 | Active, not recruiting |
| NCT04747002 | 100 participants, Randomized, Parallel Assignment, Opel label |
DSP-7888 | Second line | RFS | 2 | Recruiting |
| NCT03761914 | 90 participants, Non-Randomized, Parallel Assignment, Opel label |
galinpepimut-S, Pembrolizumab |
Second or later lines | TRAEs, ORR, CR | 1/2 | Active, not recruiting |
| NCT02396134 | 133 participants, Randomized, Parallel Assignment, Triple masking |
CMVpp65-A*0201 peptide vaccine | First line | CMV reactivation and CD8+ T cells binding | 2 | Active, not recruiting |
| NCT02636582 | 13 participants, Randomized, Parallel Assignment, Single masking (Participant) |
Nelipepimut-S Plus GM-CSF Vaccine, Sargramostim |
First line | Evaluate CTL | 2 | Active, not recruiting |
| NCT05127824 | 42 participants, Randomized, Factorial Assignment, Open label |
Autologous alpha-DC1/TBVA vaccine, Cabozantinib |
First line | Immune response, Safety |
2 | Not yet recruiting |
| NCT04197687 | 480 participants, Randomized, Parallel Assignment, Double blinded (participant, care provider) |
Multi-epitope HER2 Peptide Vaccine TPIV100, Pertuzumab, Sargramostim, Trastuzumab, Trastuzumab Emtansine |
Second or later lines | iDFS | 2 | Recruiting |
| NCT05243862 | 28 participants, Single Group Assignment, Open label |
PolyPEPI1018, Atezolizumab |
Third or later lines | AEs, Safety | 2 | Not yet recruiting |
| NCT02126579 | 62 participants, Randomized, Parallel Assignment, Open label |
Peptide Vaccine (LPV7) + Tetanus peptide, PolyICLC |
Second or later lines | Safety and toxicity, T cell response | 1/2 | Active, not recruiting |
| NCT00703105 | 36 participants, Single Group Assignment, Open label |
DC vaccination | Second or later lines | Immune response | 2 | Recruiting |
| NCT02818426 | 54 participants, Single Group Assignment, Open label |
UCPVax | Third or later lines | DLT | 1/2 | Recruiting |
| NCT03047928 | 50 participants, Single Group Assignment, Open label |
Nivolumab, PD-L1/IDO peptide vaccine |
Second or later lines | AEs | 1/2 | Recruiting |
| NCT02960230 | 49 participants, Non-randomized, Parallel Assignment, Open label |
K27M peptide, Nivolumab | Second or later lines | AEs, OS |
1/2 | Recruiting |
| NCT04206254 | 80 participants, Randomized, Parallel Assignment, Open label |
gp96 | Second or later lines | 2-years RFS | 2/3 | Not yet recruiting |
| NCT04364230 | 44 participants, Single Group Assignment, Open label |
6MHP, NeoAg-mBRAF, PolyICLC, CDX-1140 |
First line | Safety of CDX-1140 + melanoma peptide vaccine, Immunogenicity |
1/2 | Recruiting |
| NCT04280848 | 28 participants, Single Group Assignment, Open label |
UCPVax | Second or later lines | Immunogenicity | 1/2 | Active, not recruiting |
| NCT03946358 | 47 participants, Single Group Assignment, Open label |
Atezolizumab, UCPVax | Second or later lines | ORR | 2 | Recruiting |
| NCT03560752 | 36 participants, Single Group Assignment, Open label |
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine | Second or later lines | AEs | 2 | Recruiting |
| NCT04051307 | 48 participants, Single Group Assignment, Open label |
PD-L1 peptide: PD-L1 Long(19–27), Arginase1 peptide: ArgLong2(169–206) | First line | Immune response | 1/2 | Recruiting |
| NCT03617328 | 30 participants, Randomized, Parallel Assignment, Open label |
6MHP, Montanide ISA-51, polyICLC, CDX-1127 | First or second line | Safety and immunogenicity | 1/2 | Recruiting |
| NCT01885702 | 25 participants, Non-Randomized, Parallel Assignment, Open label |
DC vaccination | First or second line | Safety and feasibility | 1/2 | Active, not recruiting |
| NCT02802943 | 56 participants, Non-Randomized, Parallel Assignment, Open label |
Peptide Vaccine, Imiquimod | First or second line | Induction of peptide-specific T cell responses | 2 | Recruiting |
| NCT03715985 | 12 participants, Sequential Assignment, Open label |
EVAX-01-CAF09b | Second or later line | Safety and tolerability | 1/2 | Active, not recruiting |
| NCT05096481 | 120 participants, Single Group Assignment, Open label |
PEP-CMV, Temozolomide, Tetanus Diphtheria Vaccine |
Second line | PFS, OS | 2 | Not yet recruiting |
| NCT04580771 | 35 participants, Single Group Assignment, Open label |
Cisplatin, Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101, Radiation Therapy | First line | Toxicity | 2 | Recruiting |
| NCT02455557 | 66 participants, Single Group Assignment, Open label |
Montanide ISA 51 VG, Sargramostim, SVN53-67/M57-KLH Peptide Vaccine, Temozolomide | Second line | PFS |
2 | Active, not recruiting |
| NCT03821272 | 20 participants, Randomized, Parallel Assignment, Open label |
PepCan | Second line | AEs | 1/2 | Recruiting |
| NCT02358187 | 25 participants, Randomized, Single Group Assignment, Open label |
HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC | Third line | Tumor shrinkage or stable disease | 2 | Recruiting |
| NCT04114825 | 180 participants, Randomized, Parallel Assignment, Quadruple masking |
RV001V | Second or later line | Time to PSA progression | 2 | Active, not recruiting |
| NCT05232851 | 24 participants, Randomized, Parallel Assignment, Open label |
Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101, Pembrolizumab | First line | ctHPVDNA response | 1/2 | Recruiting |
| NCT01697527 | 6 participants, Single Group Assignment, Open label |
Aldesleukin, fludarabine phosphate, cyclophosphamide, NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL, DC therapy, fludeoxyglucose F 18, PET | Second or later line | Clinical response | 2 | Active, not recruiting |
| NCT03384914 | 110 participants, Randomized Parallel Assignment, Open label |
DC1 Vaccine, WOKVAC Vaccine | Second or later line | Immunogenicity | 2 | Recruiting |
| NCT05163080 | 265 participants, Randomized Parallel Assignment, Double-Blind |
SurVaxM | Second or later line | OS | 2 | Recruiting |
| NCT01814813 | 90 participants, Randomized, Parallel Assignment, Open label |
HSPPC-96, bevacizumab | First line | OS | 2 | Active, not recruiting |
| NCT04912765 | 60 participants, Single Group Assignment, Open label |
Neoantigen DC Vaccine, Nivolumab | Second or later line | 24-months Relapse Free Survival | 2 | Recruiting |
| NCT03633110 | 24 participants, Non-Randomized, Single Group Assignment, Open label |
GEN-009 Adjuvanted Vaccine, Nivolumab, Pembrolizumab | First line | AEs, T-cell responses | 1/2 | Active, not recruiting |
| NCT02506933 | 102 participants, Randomized, Parallel Assignment, Double blinded (Participant and Investigator) |
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine | First line | CMV events, Severe AEs | 2 | Active, not recruiting |
| NCT02134925 | 110 participants, Randomized, Parallel Assignment, Double blinded (Participant and Investigator) |
MUC1 Peptide-Poly-ICLC Vaccine | First or second line | Change in Anti-MUC1 Immunoglobulin G (IgG) Levels | 2 | Active, not recruiting |
| NCT04060277 | 128 participants, Randomized, Parallel Assignment, Double blinded (Participant and Care Provider) |
Letermovir, Multi-peptide CMV-Modified Vaccinia Ankara Vaccine | First line | Clinically significant cytomegalovirus | 2 | Recruiting |
| NCT03284866 | 536 participants, Randomized, Parallel Assignment, Double blinded (Participant and Investigator) |
Recombinant Human Papillomavirus Nonavalent Vaccine | Second or later line | Lesions occurrences | 3 | Recruiting |
| NCT02543749 | 30 participants, Single Group Assignment, Open Label | DC vaccine | First line | DC toxicity Parameters using CTC | 1/2 | Recruiting |
| NCT02334735 | 36 participants, Randomized, Parallel Assignment, Open Label | DC Vaccine, Montanide Vaccine, Poly-ICLC | First line | Humoral immune response | 2 | Active, not recruiting |
| NCT04445064 | 11 participants, Randomized, Parallel Assignment, Open Label | IO102 | First line | Number of participants with a T-cell peptide-specific response to the vaccine | 2 | Recruiting |