10 completed, 3 terminated, 1 active not recruiting, 1 temporarily not available. 10 Phase 2, 4 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 6, Terminated 2, Active not recruiting 1, Withdrawn 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 3 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide Vigil, Irinotecan, Temozolomide - Ewing Sarcoma, Ewing Family of Tumors | Phase 3 | Terminated | Gradalis, Inc. | 32 | 2018-08-21 | 2023-04-26 |
| A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers Vigil, Atezolizumab - Advanced Gynecological Cancers, Ovarian Cancer | Phase 2 | Completed | Gradalis, Inc. | 25 | 2017-05-31 | 2023-04-05 |
| Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma pbi-shRNA™ EWS/FLI1 Type 1 Lipoplex - Ewing's Sarcoma, Ewing Family of Tumors | Phase 1 | Completed | Gradalis, Inc. | 7 | 2016-10-01 | 2023-11-13 |
| Pilot Study of Durvalumab and Vigil in Advanced Women's Cancers Vigil, Durvalumab - Breast Cancer, Ovarian Cancer | Phase 2 | Completed | Mary Crowley Medical Research Center | 13 | 2016-06-03 | 2021-01-27 |
| Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer Vigil™, Nivolumab - Advanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer | Phase 2 | Withdrawn | Gradalis, Inc. | 2016-03-01 | 2017-07-31 | |
| A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma Vigil, Temozolomide, Irinotecan - Ewing's Sarcoma | Phase 2 | Completed | Gradalis, Inc. | 22 | 2016-02-10 | 2022-12-22 |
| Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma Vigil, Pembrolizumab - Melanoma Recurrent, Malignant Melanoma | Phase 1 | Completed | Gradalis, Inc. | 2 | 2015-10-01 | 2017-09-27 |
| A Trial of Vigil for Participants With Ovarian Cancer Vigil, Placebo - Ovarian Cancer, Ovarian Neoplasms | Phase 2 | Active not recruiting | Gradalis, Inc. | 92 | 2015-02-01 | 2025-10-29 |
| Salvage Ovarian FANG™ Vaccine + Carboplatinum Vigil™ Vaccine, Carboplatinum, Carboplatinum and Taxol - Stage III Ovarian Cancer, Stage IV Ovarian Cancer | Phase 2 | Completed | Gradalis, Inc. | 1 | 2013-06-01 | 2018-06-19 |
| Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases Vigil™ Vaccine, Placebo - Colon Cancer | Phase 2 | Terminated | Gradalis, Inc. | 3 | 2012-03-01 | 2021-11-01 |
| Salvage Ovarian FANG™ Vaccine + Bevacizumab Vigil™ Vaccine, Bevacizumab - Stage III Ovarian Cancer, Stage IV Ovarian Cancer | Phase 2 | Completed | Gradalis, Inc. | 5 | 2012-03-01 | 2021-10-19 |
| Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer pbi-shRNA STMN1 LP - Advanced Cancer, Metastatic Cancer | Phase 1 | Completed | Gradalis, Inc. | 20 | 2012-02-01 | 2018-02-22 |
| Phase II FANG™ in Advanced Melanoma Vigil™ Vaccine - Advanced Melanoma | Phase 2 | Terminated | Gradalis, Inc. | 18 | 2011-10-01 | 2018-05-24 |
| A Trial of FANG™ Vaccine for Participants With Ovarian Cancer Vigil™ - Ovarian Cancer | Phase 2 | Completed | Gradalis, Inc. | 39 | 2011-03-08 | 2025-06-08 |
| Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer Vigil™ - Ewings Sarcoma, Non Small Cell Lung Cancer | Phase 1 | Completed | Gradalis, Inc. | 100 | 2009-12-01 | 2022-03-15 |
| Expanded Access of Vigil in Solid Tumors Vigil - Solid Tumor, Ewing Sarcoma | Temporarily not available | Gradalis, Inc. | 2025-06-05 |
Ovarian Neoplasms (7) · Sarcoma, Ewing (5) · Melanoma (3) · Sarcoma (3) · Uterine Cervical Neoplasms (3) · Uterine Neoplasms (3) · Carcinoma, Non-Small-Cell Lung (2) · Carcinoma, Ovarian Epithelial (2) · Fallopian Tube Neoplasms (2) · Neuroectodermal Tumors, Primitive, Peripheral (2) · Rare Diseases (2) · Bone Neoplasms (1) · Breast Neoplasms (1) · Colonic Neoplasms (1) · Colorectal Neoplasms (1)
FANG vaccine (10) · Irinotecan (2) · Temozolomide (2) · Bevacizumab (1) · Carboplatin (1) · Docetaxel (1) · Gemcitabine (1) · Immune Checkpoint Inhibitors (1) · Nivolumab (1) · Paclitaxel (1) · Vascular Endothelial Growth Factor A (1) · atezolizumab (1) · durvalumab (1) · pembrolizumab (1)
United States (16)
John Nemunaitis, MD (7) · Minal Barve, MD (7) · Luisa Manning, MD (2)
PMID 33364285, PMID 34452019, PMID 22186789, PMID 25917459, PMID 27109631, PMID 27678295, PMID 33271095, PMID 33715892, PMID 33753870, PMID 34696309