Table 2 Important clinical trials regarding in situ vaccination
From: Nanomaterials-driven in situ vaccination: a novel frontier in tumor immunotherapy
Study | NCT Number | Title | Status | Conditions | Interventions | Outcome Measures | Phases | Enrollment | Country | Major Outcome |
|---|---|---|---|---|---|---|---|---|---|---|
1 | NCT02423863 | In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol® (Poly-ICLC) | Completed | Melanoma, Head and Neck Cancer, Sarcoma, and Non-Melanoma Skin Cancers | Biological: Hiltonol | Therapeutic Efficacy and Safety of Hiltonol | Phase 2 | 26 | USA | Study results have not been submitted |
2 | NCT02977156 | Immunization Strategy With Intra-tumoral Injections of Pexa-Vec With Ipilimumab in Metastatic / Advanced Solid Tumors. (ISI-JX) | Completed | Advanced Tumor, Metastatic Tumor | Biological: Pexa-Vec; Drug: Ipilimumab | 3-month Objective Response Rate (ORR) and Dose Limiting Toxicities (DLTs) | Phase 1 | 22 | France | Study results have not been submitted |
3 | NCT01902771 | Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors | Terminated | Brain Tumor, Glioblastoma Multiforme, High Grade Glioma | Biological: Dendritic Cell Vaccine; Biological: Tumor Lysate; Other: IM; Procedure: Leukapheresis | Toxicity and Feasibility | Phase 1 | 1 | USA | Study results have not been submitted |
4 | NCT06471673 | A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer | Recruiting | Breast Cancer | Biological: BC1 cell line; Biological: Bria-OTS regimen and CPI (tislelizumab); Bilogical: Bria-OTS regimen and CPI (tislelizumab) expansion cohort | Safety and Tumor Response | Phase 1 and Phase 2 | 18 | USA | Study results have not been submitted |
5 | NCT02643303 | A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers | Completed | Various types of Malignancies | Drug: Durvalumab; Drug: Tremelimumab; Drug: Poly-ICLC | Treatment-emergent Adverse Events (TEAEs), and Median Progression-free Survival (PFS) | Phase 1 and Phase 2 | 58 | USA | TEAEs:33.3-100% PFS:43-157days |
6 | NCT03262103 | Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer | Completed | Prostate Cancer | Biological: Intratumoral (IT) Poly ICLC 0.5 mg; Biological: IT Poly ICLC 1.0 mg; Biological: Intramuscular (IM) Poly ICLC; Procedure: Radical Prostatectomy | Dose-Limiting Toxicity Level, Adverse Events, and Time to Prostate-Special Antigen (PSA) Progression | Phase 1 | 13 | USA | Study results have not been submitted |
7 | NCT03789097 | Vaccination With Flt3L, Radiation, and Poly-ICLC | Recruiting | Haed and Neck Squamous Cell Carcinoma, Metastatic Breast Cancer, and Non-Hodgkin’s Lymphoma | Drug: Pembrolizumab; Drug: FLT3L; Radiation: Radiation; Drug: Poly ICLC | Dose Limiting Toxicity and ORR | Phase 1 and Phase 2 | 56 | USA | Study results have not been submitted |
8 | NCT04042506 | SBRT as a Vaccination for Metastatic Melanoma | Withdrawn | Metastatic Melanoma | Drug: Nivolumab 10 MG/ML Intraveneous Solution; Radiation: Stereotactic Body Radiation Therapy | Safety and Unradiated Lesions Response | Phase 2 | 0 | USA | Study results have not been submitted |
9 | NCT06343077 | Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance | Recruiting | Prostate Cancer Patients on Active Surveillance | Drug: Poly-ICLC IM injection; Drug: Poly-ICLC IT injection | Proportion of Subjects Upgrade and Proportion of Subjects Downgrade, and Adverse Events | Phase 2 | 114 | USA | Study results have not been submitted |
10 | NCT01741038 | AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer | Withdrawn | Metastatic Colorectal Cancer | Biological: AlloStim®; Procedure: cryoablation; Other: Physician’s Choice | Overall Survival and Safety | Phase 2 and Phase 3 | 0 | Thailand | Study results have not been submitted |
11 | NCT02885727 | Durvalumab Plus “Booster” RT for Metastatic Adenocarcinoma Pancreas Cancer Post Chemotherapy (GCC 1598) (Panc-Durval + RT) | Withdrawn | Metastatic Pancreas Cancer | Drug: Durvalumab; Radiation: Radiation Therapy | Improvement in median PFS | Phase 2 | 0 | No Data | Study results have not been submitted |
12 | NCT03490760 | Durvalumab and “Booster” Radiation in Metastatic Adenocarcinoma of the Pancreas | Terminated | Adenocarcinoma of the Pancreas | Drug: Durvalumab; Radiation: Radiation Therapy | PFS, ORR, Clinical Benefit Rate (CBR), and Overall Survival (OS) | Phase 2 | 9 | USA | PFS:53 days ORR:0 CBR:16.7% OS:85 days |
13 | NCT02380443 | AlloStim® Immunotherapy Dosing Alone or in Combination with Cryoablation in Metastatic Colorectal Cancer | Completed | Colorectal Cancer Metastatic | Biological: AlloStim; Procedure: Cryoablation | Safety and Anti-Tumor Effect | Phase 2 | 12 | USA | Study results have not been submitted |
14 | NCT01984892 | Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC) (Hiltonol) | Terminated | Breast Cancer, Melanoma, Squamous Cell Carcinoma of the Skin, Sarcoma of the skin, and the ErBasal Cell Cancer of the Skin | Drug: Poly-ICLC | PFS, Therapeutic Effect, and OS | Phase 2 | 8 | USA | PFS:41 weeks OS:100% |