Table 3.
Third-generation combination immunotherapy.
| Clinical Trial # | Trial Name | Indication | Status | Trial Phase | n | Treatments |
|---|---|---|---|---|---|---|
| NCT03315871 | Combination Immunotherapy in Biochemically Recurrent Prostate Cancer | Prostate cancer | Recruiting | II | 34 | PROSTVAC-V/F Bintrafusp alfa |
| NCT04432597 | HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers | HPV positive cancers | Recruiting | I/II | 76 | PRGN-2009 Bintrafusp alfa |
| NCT04296942 | BN-Brachyury, Entinostat, Ado-trastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) | Breast cancer | Recruiting | I | 65 | Brachyury-TRICOM Bintrafusp alfa Entinostat Ado-trastuzumab |
| NCT04574583 | Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With Bintrafusp Alfa (M7824 or TGF-beta “Trap”/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) | Metastatic cancer Solid tumors |
Recruiting | I/II | 105 | MVA-BN-CV301 FPV-CV301 Bintrafusp alfa SX-682 |
| NCT04247282 | Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection | Head and neck cancer | Recruiting | I/II | 40 | TriAdeno vaccine Bintrafusp alfa N-803/ALT-803 |
| NCT04287868 | Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies | HPV-positive cancers | Recruiting | I/II | 40 | PDS0101 Bintrafusp alfa NHS-IL12 |
| NCT04491955 | Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers | Small bowel cancer Colorectal cancer |
Recruiting | II | 80 | CV301 Bintrafusp alfa N-803 NHS-IL12 |
| NCT03493945 | Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, ALT-803 and Epacadostat (QuEST1) | Prostate cancer Advanced solid tumor |
Recruiting | I/II | 113 | MVA-BN-Brachyury FPV-Brachyury Bintrafusp alfa Epacadostat ALT-803 |
| NCT00834665 | Phase I/II Clinical Trial Combining hTERT Tumor Vaccine & Autologous T Cells in Patients With Advanced Myeloma | Multiple myeloma | Completed | I | 59 | hTERT vaccine GM-CSF Pneumococcal conjugate vaccine T-cell infusion |
| NCT02737475 | An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread | Advanced solid cancer | Recruiting | I/II | 207 | DPV-001 BMS-986178 Nivolumab Ipilimumab Cyclophosphamide |
| NCT01245673 | Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma | Myeloma | Completed | II | 28 | MAGE-A3/GM-CSF Pneumococcal conjugate vaccine Lenalidomide Activated/costimulated autologous T cells |
| NCT03136506 NCT03329248 NCT03387085 NCT03387098 NCT03387111 |
QUILT-3.039 QUILT-3.060 QUILT-3.067 QUILT-3.070 QUILT-3.090 |
Pancreatic cancer Triple-negative breast cancer Squamous cell carcinoma |
Active, not recruiting | I/II | 3–173 | ALT-803/N-803 Avelumab aNK haNK Nab-paclitaxel Bevacizumab Necitumumab Leucovorin Capecitabine 5-Fluorouracil Cyclophosphamide Oxaliplatin Cisplatin Lovaza SBRT Aldoxorubicin ETBX-051 ETBX-061 ETBX-011 GI-4000 GI-6207 GI-6301 |
#: NCT: clinicaltrials.gov identification number. PROSTVAC-V/F: recombinant vaccinia and fowlpox vaccines expressing prostate-specific antigen, LFA-3, ICAM-1, B7.1. Bintrafusp alfa: bifunctional molecule combining anti-PD-L1 antibody with TGF-βRII (TGF-β Trap). MVA-BN-Brachyury: modified vaccinia Ankara vaccine expressing tumor-associated antigen Brachyury. FPV-Brachyury: fowlpox vaccine expressing tumor-associated antigen Brachyury. ALT-803 (also called N-803): fusion molecule containing two molecules of IL-15 superagonist, two molecules of IL15α receptor and dimeric human IgG1 Fc. TriAdeno vaccine: adenoviral vaccine containing tumor-associated antigens CEA, MIC1 and Brachyury. PRGN-2009: gorilla adenoviral vaccine targeting HPV 16 and 18 oncoproteins E6 and E7. CV01 (FPV-CV301): poxvirus-based prime/boost vaccine targeting tumor-associated antigens CEA and MUC1. NHS-IL12: fusion immunocytokine containing two IL12 heterodimers and tumor necrosis targeting NHS76 antibody. SX-682: small molecule inhibitor of CXCR1/2 chemokine receptors. PDS0101: vaccine targeting HPV16 antigens. DPV-001: dendritic cell-targeted microvesicle vaccine. BMS-986178: OX-40 agonist monoclonal antibody. GM-CSF: granulocyte-macrophage colony-stimulating factor. MAGE-A3/GM-CSF: peptide vaccine targeting tumor antigen MAGE-A3 combined with immune adjuvant GM-CSF. aNK: activated natural killer (NK) cells. haNK: high-affinity NK cell. SBRT: stereotactic body radiation therapy. ETBX-051: adenoviral Brachyury vaccine. ETBX-061: adenoviral MUC1 vaccine. ETBX-011: adenoviral CEA vaccine. GI-4000: yeast-derived vaccine expressing mutant KRAS proteins. GI-6207: yeast-derived vaccine expressing CEA. GI-6301: yeast-derived vaccine expressing Brachyury.