Table 1. Active Immunotherapy Clinical Trials.
A list of all the phase I–IV clinical trials currently being conducted in the United States as listed by the National Cancer Institute and organized by type of immunotherapy.
| Name | Identifying Number | Class | Phase | Indication | Lead Organization and Collaborators | Information |
|---|---|---|---|---|---|---|
| Rovalpituzumab Tesirine | NCT02709889 | Antibody Drug Conjugate | I/II | DLL-3 expressing advanced solid tumors | Stemcentrx | This anti-Delta like ligand 3 Ab conjugated to pyrrolobenzodiazepine (DNA crosslinking agent) is administered IV every 6 weeks |
| Iodine I 131 Monoclonal Antibody 3F8 | NCT00445965 | Antibody Drug Conjugate | II | GD2 expressing CNS and leptomeningeal tumors | Memorial Sloan-Kettering Cancer Center | Radioactive anti-Ganglioside G2 antibody administered IT |
| ABT-414 | NCT02573324 | Antibody Drug Conjugate | II | Newly Diagnosed GBM with EGFR Amplification | Abbvie | Anti-EGFR Ab conjugated to monomethyl auristatin F (Cytotoxic) given with standard TMZ and RT |
| Iodine I 131 Monoclonal Antibody 8H9 | NCT00089245 | Antibody Drug Conjugate | I | 8H9 Reactive CNS or Leptomeningeal tumor unresponsive to conventional therapy | Memorial Sloan-Kettering Cancer Center | Radioactive Ab targeting B7-H3 administered IT |
| D2C7-IT (anti-EGFRwt, EGFRvIII recombinant immunotoxin) | NCT02303678 | Antibody Drug Conjugate | I | Recurrent GBM | Duke University Medical Center | anti-EGFRwt, EGFRvIII Ab fragment conjugated to genetically engineered Pseudomonas Exotoxin delivered intratumorally |
| CC-122 | NCT01421524 | IFN immunomodulatory | I | Advanced Solid Tumors | Celgene Corporation | Dose escalation study of CC-122 (a pleiotropic pathway modifier) which enhances IFN production and is considered immunostimulatory |
| ICT-107 | NCT02546102 | Dendritic Cell Vaccine | III | Newly diagnosed GBM | ImmunoCellular Therapeutics, Ltd., Novella Clinical | TMZ and placebo vs TMZ and ICT-107, ICT-107 is a DC vaccine derived from autologous mononuclear DCs pulsed with six TAAs |
| CMV pp65 DC +/− Td vaccination +/− Basiliximab | NCT02366728 | Dendritic Cell Vaccine | II | Newly Diagnosed GBM with requirement for resection | Duke University Medical Center | Standard TMZ and RT followed by Tetanus toxoid (TD) preconditioning +/− Basiliximab (anti-CD25) + CMV pp65-LAMP mRNA-pulsed autologous DCs labeled with 111In injected ID |
| Bevacizumab, Minocycline Hydrochloride, + RT | NCT01580969 | Anti-inflammatory, anti-angiogenic | I/II | Recurrent GBM | Huntsman Cancer Institute/University of Utah | Dose escalation study of oral minocycline hydrochloride, an antiinflammatory antibiotic, given in addiation to treatment with the anti-VEGF Ab, bevacizumab, and fractionated RT |
| Pembroluzimab | NCT02337686 | Checkpoint blockade inhibitor | II | Recurrent GBM with requirement for resection | MD Anderson Cancer Center | Anti-PD1 Ab given IV 6 and 3 weeks prior to surgery and dosed every 3 weeks afterwards. |
| Pembrolizumab | NCT02852655 | Checkpoint Blockade Inhibitor | I | refractory GBM with prior RT | Dana-Farber Harvard Cancer Center | Anti-PD1 Ab monotherapy given IV 14 days prior to surgery and then dosed every 3 weeks afterwards |
| Pembrolizumab | NCT02658279 | Checkpoint Blockade Inhibitor | I | Recurrent HGG with prior RT and cytotoxic therapy, tumor has >30 mutations | Memorial Sloan-Kettering Cancer Center | IV administration of anti-PD1 Ab given every 3 weeks until disease progression |
| Pembroluzimab + RT + bevacizumab | NCT02313272 | Checkpoint Blockade Inhibitor | I | Recurrent HGG | Moffitt Cancer Center | Standard RT with IV anti-PD1 Ab administration every 3 weeks and bevacizumab IV every 2 weeks |
| MRI guided laser surgery + pembroluzimab | NCT02311582 | Checkpoint blockade inhibitor | I/II | Recurrent GBM | Siteman Cancer Center at Washington University | After MRI guided laser surgery, patients receive IV anti-PD1 Ab 1 week later followed by every 3 weeks for 24 months. |
| Tremelimumab and Durvalumab | NCT02794883 | Checkpoint blockade Inhibitor | II | Recurrent GBM | Northwestern University | Anti-CTLA4 (tremelimumab) and anti-PDL1 (durvalumab) antibodies given IV in combination or separately over multiple weeks |
| Urelumab (Anti-CD137 Antibody) or Anti-LAG3 Antibody +/− Nivolumab | NCT02658981 | Checkpoint Blockade Inhibitor | I | Progressive or Recurrent GBM | Adult Brain Tumor Consortium | Phase I study assessing combination of checkpoint blockade inhibitors targeting CD137, LAG3, and PD1 when administered IV. |
| Nivolumab + RT | NCT02617589 | Checkpoint blockade inhibitor | III | Newly diagnosed GBM, methylated and unmethylated | Bristol-Myers Squibb, Ono Pharmaceutical Company Limited | TMZ and fractionated RT vs anti-PD1 Ab given with fractionated RT every 2 weeks followed by Anti-PD1 Ab alone every 4 weeks |
| Nivolumab + RT | NCT02829931 | Checkpoint Blockade Inhibitor | I | Recurrent HGG | Moffitt Cancer Center | Fractonated RT given with anti-PD1 Ab administered IV every 2 weeks for 4 months then every 4 weeks |
| Nivolumab +/− pp65 RNA pulsed DC Vaccination | NCT02529072 | Checkpoint Blockade Inhibitor +/− DC vaccine | I | Progressive HGG | Duke University Medical Center | Pre-operative anti-PD1 Ab given every 2 weeks for 8 weeks followed by tumoral resection then multiple CMV pp65-LAMP mRNA-pulsed autologous DC vaccinations given with continued anti-PD1 Ab therapy |
| AGEN-1884 (Anti-CTLA4) | NCT02694822 | Checkpoint Blockade Inhibitor | I | Advanced Solid Tumors | Agenus Inc. | Phase I study of anti-CTLA4 Ab monotherapy |
| Ipilumamab and Imatinib mesylate | NCT01738139 | Checkpoint Blockade Inhibitor + RTK inhibitor | I | Unresectable, Kit+ Solid Tumors | MD Anderson Cancer Center | Dose escalation study of Anti-CTLA4 Ab administered IV and Kit inhibitor administered orally |
| MEDI4736 + bevacizumab | NCT02336165 | Checkpoint blockade inhibitor | II | Newly Diagnosed GBM | Ludwig Institute for Cancer Research | Anti-PDL1 Ab administered IV +/− bevacizumab IV +/− standard RT to assess clinical efficacy of PDL1 blockade in different combination therapies |
| Nivolumab + TMZ +RT | NCT02667587 | Checkpoint blockade Inhibitor | II | Newly Diagnosed GBM | Bristol-Myers Squibb, Ono Pharmaceutical Company Limited | Anti-PD1 Ab given in combination to standard RT and TMZ |
| Pembroluzimab +/− bevacizumab | NCT02337491 | Checkpoint blockade inhibitor + anti-angiogenic | II | Recurrent GBM, no prior treatment with bevacizumab | Dana-Farber Cancer Institute | Trial assessing anti-PD1 Ab combined with anti-VEG Ab, both administered IV |
| Epacadostat + Nivolumab | NCT02327078 | IDO1 Inhibitor + Checkpoint blockade inhibitor | II | Select Advanced Cancers | Incyte Corporation | Anti-PD1 Ab given every 2 weeks with dose escalation of epadostat, an IDO1 inhibitor |
| BLZ945 + PDR001 | NCT02829723 | Checkpoint blockade inhibitor + Csf1 R inhibitor | I/II | Advanced solid tumors | Novartis Pharmaceuticals Corporation | Oral CSF1R inhibitor combined with IV anti-PD1 Ab administration |
| Pembrozluzimab + TMZ + RT +/− Vitespen (heat shock protein-peptide complex [HSPPC]-96 vaccine) | NCT03018288 | Checkpoint blockade Inhibitor + Vaccine | II | Newly Diagnosed GBM | NCI - Center for Cancer Research | Standard of care RT and TMZ with anti-PD1 Ab therapy +/− 4 weekly doses of vitespen (vaccine developed from heat shock protein (gp96)-peptide complex purified patient’s own tumoral tissue) |
| USL311 +/− Lomustine | NCT02765165 | CXCR4 inhibitor + cytotoxic agent | I/II | Recurrent GBM, Advanced solid tumors | MD Anderson Cancer Center | CXCR4 inhibitor administered +/− lomustine (alkylating agent) |
| PLX3397 | NCT02390752 | CSF1R, cKit inhibitor | I/II | Brain tumors in patients age 3–30 | NCI - Center for Cancer Research | Safety and tolerability study for PLX3397 (CSF1R and Kit inhibitor) dosing in adolescents with refractory solid tumors. |
| Low-Dose Capecitabine and Bevacizumab | NCT02669173 | Anti-MDSC, antiangiogenic | I | GBM with planned resection | Case Comprehensive Cancer Center | Capecitabine (thymidylate synthase inhibitor) dosed orally with bevacizumab IV given on days 1, 15, and every 28 days after |
| IL13R alpha 2-specific, CD19 CAR T cells | NCT02208362 | CAR-T Therapy | I | IL13R alpha 2+ Recurrent and refractory GBM | City of Hope Comprehensive Cancer Center | Intratumoral infusion of IL13R alpha 2-specific, CD19 CAR T cells with potential for additional intraventricular infusions |
| EGFRvIII CAR T cell therapy | NCT02209376 | CAR-T Therapy | I | EGFRvIII + Relapsed and Recurrent GBM | University of Pennsylvania/Abramson Cancer Center | Open label, phase I pilot study of EGFRvIII CAR T cell monotherapy |
| HER2-CD28-CMV CAR T Cell Therapy | NCT01109095 | CAR-T Therapy | I | HER2+ Recurrent or Progressive GBM | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | IV infusion of HER2-CAR CMV-T cells with potential for 6 additional doses if radiographic response recognized |
| EGFRvIII CAR T cell therapy | NCT02664363 | CAR-T Therapy | I | EGFRvIII + Newly Diagnosed GBM | Duke University Medical Center | IV administration of EGFRvIII CAR T cells |
| Autologous CMV-reactive CTLs + TMZ | NCT02661282 | T cell therapy | I/II | Newly diagnosed and recurrent GBM | MD Anderson Cancer Center | Patients undergo leukapheresis and their CTLs are lentivirally infected and reintroduced to patient IV after TMZ therapy. |
| HSPPC96 vaccine +/− bevacizumab | NCT01814813 | Vaccine +/− antiangiogenic | II | Recurrent, resectable GBM | Alliance for Clinical Trials in Oncology | Heat shock protein-peptide complexes made from a patient’s own tumor tissue given ID with anti-VEGF Ab given IV |
| Gliovac + GM-CSF + Cyclophosphamide +/− bevacizumab | NCT01903330 | Vaccine + Immunomodulatory agent + Cytotoxic agent | II | First or secondly relapsing GBM | UC Irvine Health/Chao Family Comprehensive Cancer Center | Vaccine derived from tumor lysates and GM-CSF given ID with oral administration of Cyclophosphamide. Anti-VEGF Ab given IV. |
| SurVaxM peptide vaccine + TMZ | NCT02455557 | Peptide Vaccine | II | Survivin +, Newly Diagnosed GBM | Roswell Park Cancer Institute | SurVaxM peptide vaccine targeting survivin given ID 4 times over 8 weeks with standard TMZ dosing PO or IV |
| Personalized neoantigen peptide vaccine + poly-ICLC | NCT02510950 | Peptide Vaccine | No Phase | Newly diagnosed GBM with consent for genome sequencing | Siteman Cancer Center at Washington University | After maintenance TMZ therapy and preparation of personalized neo-antigen vaccine, personalized neo-angtien vaccine + poly-ICLC vaccine given in multiple dosing cycles |
| NeoVax (neoantigen-based melanoma-poly-ICLC vaccine) +RT | NCT02287428 | Peptide Vaccine | I | Newly Diagnosed or Recurrent GBM | Dana-Farber Harvard Cancer Center | Six weeks of standard RT followed by a series of personalized tumor vaccinations |
| DSP-7888 | NCT02498665 | Peptide Vaccine | I | Advanced Solid Tumors | Boston Biomedical, Inc | Peptide vaccine derived from the gene products of the Wilms Tumor 1 gene which is expressed by subsets of tumor cells |
| insulin-like growth factor receptor-1 (IGF-1 R)/antisense oligodeoxynucleotide (AS ODN)-treated tumor cells | NCT02507583 | Tumor Cell Vaccine | I | IGF-1R+ GBM | Thomas Jefferson University Hospital | Tumor cells from patient are purified and treated with insulin-like growth factor receptor-1 (IGF-1 R)/antisense oligodeoxynucleotide, and reinjected into patient to induce immune response |
| carcinoembryonic antigen-expressing measles virus | NCT00390299 | Oncolytic Viral Therapy | I | Recurrent GBM | Mayo Clinic | Oncolytic carcinoembryonic antigen-expressing measles virus injected intratumorally after resection |
| PVS-RIPO | NCT01491893 | Oncolytic Virus | I | Recurrent GBM | Duke University Medical Center | PVSRIPO (recombinant oncolytic poliovirus PVSRIPO) delivered intratumorally by convection-enhanced delivery |
| Veledimex + Ad-RTS-hIL-12 | NCT02026271 | Immunostimulatory Virus | I | Recurrent Grade III/IV glioma | Ziopharm Oncology Inc | Adenoviral vector causing overexpression of hIL-12 injected intratumorally with velemidex activator ligand taken orally to enhance the immunostimulatory effects of the virus |
| AdhCMV-Flt3L and Ad-hCMV-TK + TMZ + RT + Valacyclovir | NCT01811992 | Suicide Gene/Immuno-stimulatory Viral Therapy | I | Newly diagnosed Grade III/IV glioma | University of Michigan Comprehensive Cancer Center | Standard TMZ + RT therapy with adenoviral vectors injected intratumorally. One vector delivers a suicide gene to cancer cells; the other increases DC activation by delivering immunostimulatory gene, Flt3L |
| Combination Adenovirus + Pembrolizumab | NCT02798406 | Oncolytic Virus + Checkpoint blockade Inhibitor | II | Newly Diagnosed GBM and secondly recurrent GBM | DNAtrix, Inc., Merck and Company Inc | Oncolytic adenovirus, DNX-2401, administered intratumorally, followed by anti-PD1 Ab administered every 3 weeks |