Table 1.
Clinical trials recently started to investigate the therapeutic profile of Toll-like receptor agonists in cancer patients.*
| Molecule | Indication(s) | Phase | Status | Route | Notes | Ref. | |
|---|---|---|---|---|---|---|---|
| Ampligen™ | Ovarian carcinoma | I/II | Active, not recruiting | Intraperitoneal | In combination with DC-based vaccination | NCT02432378 | |
| |
Peritoneal tumors |
I/II |
Recruiting |
Intravenous |
In combination with DC-based vaccination |
NCT02151448 |
|
| AS15 |
Breast carcinoma |
I |
Recruiting |
Intramuscular |
Combined with peptide-based vaccination |
NCT02364492 |
|
| BCG | Bladder carcinoma | I | Recruiting | Intravesical | In combination with lambrolizumab | NCT02324582 | |
| I/II | Recruiting | Intravesical | Combined with IL-15-based immunotherapy | NCT02138734 | |||
| II | Completed | Intravesical | Alone or combined with hyaluronic acid | NCT02207608 | |||
| II | Not yet recruiting | Subcutaneous | As standalone intervention | NCT02326168 | |||
| II | Recruiting | Intravesical | As standalone intervention | NCT02281383 | |||
| n.a. | Recruiting | Intravesical | In combination with mitomycin C-based chemotherapy | NCT02202044 | |||
| As standalone intervention | NCT02365207 | ||||||
| Lung carcinoma | I/II | Recruiting | Subcutaneous | Combined with a multipeptide-based vaccine | NCT02333474 | ||
| |
Urological tumors |
III |
Withdrawn |
Intravesical |
As active comparator |
NCT02254915 |
|
| DUK-CPG-001 |
Hematological neoplasms |
II |
Not yet recruiting |
Intravenous |
In combination with NK cell-enriched DLIs |
NCT02452697 |
|
| G100 | Follicular lymphoma | I/II | Recruiting | Intratumoral | As standalone intervention | NCT02501473 | |
| Melanoma | n.a. | Recruiting | Intramuscular | Combined with peptide-based vaccination | NCT02320305 | ||
| Soft tissue sarcoma | I | Recruiting | Intratumoral | In combination with radiation therapy | NCT02180698 | ||
| |
Solid tumors |
I |
Recruiting |
Intramuscular |
Combined with peptide-based vaccination |
NCT02387125 |
|
| Hiltonol™ | Breast carcinoma | I | Not yet recruiting | n.a. | Combined with peptide-based vaccination | NCT02427581 | |
| Colorectal carcinoma | II | Recruiting | Subcutaneous | Combined with peptide-based vaccination | NCT02134925 | ||
| Gynecological tumors | I | Recruiting | n.a. | Combined with cancer cell lysate-based vaccination | NCT02452775 | ||
| Glioblastoma | 0 | Not yet recruiting | n.a. | Combined with peptide-based vaccination plus GM-CSF | NCT02510950 | ||
| I | Recruiting | Subcutaneous | Combined with peptide-based vaccination plus GM-CSF | NCT02149225 | |||
| Glioma | II | Recruiting | Intramuscular | Combined with peptide-based vaccination | NCT02358187 | ||
| Melanoma | I/II | Recruiting | n.a. | Combined with peptide-based vaccination | NCT02425306 | ||
| II | Not yet recruiting | Subcutaneous | In combination with a DC-based vaccine | NCT02334735 | |||
| II | Recruiting | n.a. | Combined with ipilimumab, varlilumab, and a peptide vaccine targeted to DCs | NCT02413827 | |||
| Neuroectodermal tumors | II | Recruiting | Intramuscular | Combined with decitabine-based chemotherapy | NCT02332889 | ||
| NSCLC | II | Active, not recruiting | Subcutaneous | Combined with peptide-based vaccination | NCT02495636 | ||
| |
Solid tumors |
I/II |
Recruiting |
Intramuscular |
As standalone intervention |
NCT02423863 |
|
| Imiquimod | Actinic keratosis | I | Recruiting | Topical | As active comparator | NCT02404389 | |
| IV | Recruiting | Topical | Combined with PDT | NCT02281682 | |||
| Anal intraepithelial lesions | III | Recruiting | Topical | Combined with multimodal therapy | NCT02135419 | ||
| Breast carcinoma Gastric carcinoma | I | Recruiting | Topical | Combined with peptide-based vaccination plus GM-CSF | NCT02276300 | ||
| Cervical intraepithelial lesions | III | Recruiting | Topical | Alone or upon resection | NCT02329171 | ||
| Genital warts | II | Recruiting | Topical | As active comparator | NCT02482428 | ||
| Glioma | I | Recruiting | Topical | Combined with peptide-based vaccination | NCT02454634 | ||
| Lentigo maligna | III | Not yet recruiting | Topical | As standalone intervention | NCT02394132 | ||
| Mycosis fungoides | n.a. | Not yet recruiting | Topical | As standalone intervention | NCT02301494 | ||
| Nodular basal cell carcinoma | III | Not yet recruiting | Topical | After tumor debulking | NCT02242929 | ||
| Paget disease | III | Recruiting | Topical | As standalone intervention | NCT02385188 | ||
| Prostate carcinoma | I | Recruiting | Topical | Combined with peptide-based vaccination and chemotherapy | NCT02234921 | ||
| I/II | Active, not recruiting | Topical | Combined with peptide-based vaccination | NCT02452307 | |||
| |
|
II |
Recruiting |
Topical |
Combined with peptide-based vaccination |
NCT02293707 |
|
| Motolimod |
Ovarian carcinoma |
I/II |
Active, not recruiting |
Subcutaneous |
Combined with MEDI4736 and liposomal doxorubicin |
NCT02431559 |
|
| SD-101 | Lymphoma | I/II | Recruiting | Intratumoral | Combined with ipilimumab and radiotherapy | NCT02254772 | |
| In combination with radiation therapy | NCT02266147 | ||||||
| |
Melanoma |
I |
Active, not recruiting |
Intratumoral |
In combination with pembrolizumab |
NCT02521870 |
|
| VPM1002BC | Bladder carcinoma | I/II | Recruiting | Intravesical | As standalone intervention | NCT02371447 |
Abbreviations: BCG, bacillus Calmette-Guérin; DC, dendritic cell; DLI, donor lymphocyte infusion; GM-CSF, granulocyte-macrophage colony stimulating factor; IL, interleukin; n.a., not available; NK, natural killer; NSCLC, non-small-cell lung carcinoma; PDT, photodynamic therapy.
*
Initiated between 2014, May 1st and the day of submission.