^
    7d
    KEYNOTE-D88: A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=97, Active, not recruiting, NextCure, Inc. | Recruiting --> Active, not recruiting | N=209 --> 97
    Enrollment closed • Enrollment change • Checkpoint inhibition • Metastases
    |
    MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • NC410
    7d
    1B-22-2: In Situ Immunomodulation with CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients W/ Unresectable and Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, University of Southern California | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2025 --> Jan 2026
    Trial completion date • Trial primary completion date • Immunomodulating • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • CDX-1140 • Hiltonol (poly-ICLC) • Mobista (CDX-301)
    1m
    BRAVO: Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I) (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, University of Florida | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    temozolomide • cyclophosphamide • fludarabine IV
    1m
    LOKON002: Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer (clinicaltrials.gov)
    P1/2, N=47, Completed, Lokon Pharma AB | Active, not recruiting --> Completed
    Trial completion • Oncolytic virus
    |
    delolimogene mupadenorepvec (LOAd703)
    2ms
    LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors (clinicaltrials.gov)
    P1/2, N=4, Terminated, Istari Oncology, Inc. | N=15 --> 4 | Trial completion date: May 2025 --> Jun 2024 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Apr 2024; business decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Checkpoint inhibition • Pan tumor • Metastases
    |
    lerapolturev (PVS-RIPO)
    2ms
    MATCHPOINT: Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, University of Florida | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date • Checkpoint inhibition • Checkpoint block
    |
    Keytruda (pembrolizumab)
    3ms
    LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Istari Oncology, Inc. | Trial primary completion date: Jun 2024 --> Oct 2024
    Trial primary completion date • Checkpoint inhibition • IO biomarker • Checkpoint block • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • BRAF mutation • BRAF wild-type
    |
    lerapolturev (PVS-RIPO)
    3ms
    LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=25, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    Keytruda (pembrolizumab) • lerapolturev (PVS-RIPO)
    3ms
    PVSRIPO for Patients With Unresectable Melanoma (clinicaltrials.gov)
    P1, N=12, Terminated, Istari Oncology, Inc. | Completed --> Terminated; Study closed to enrollment due to business decision prior to enrolling Cohort 4
    Trial termination
    |
    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • PVR (PVR Cell Adhesion Molecule)
    |
    BRAF mutation • BRAF wild-type • CD8 positive
    |
    lerapolturev (PVS-RIPO)
    5ms
    COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov)
    P3, N=195, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Apr 2024 --> Dec 2024
    Trial completion date
    |
    IMM-101
    5ms
    KEYNOTE-D88: A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=209, Recruiting, NextCure, Inc. | N=131 --> 209
    Enrollment change • Checkpoint inhibition • Metastases
    |
    MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • NC410
    5ms
    MATCHPOINT: Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, University of Florida
    New P1 trial • Checkpoint inhibition • Checkpoint block
    |
    Keytruda (pembrolizumab)
    5ms
    PRIMUS006: A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Karen Carty
    New P2 trial • Metastases
    |
    Keytruda (pembrolizumab) • gemcitabine • IMM-101
    6ms
    CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1; N=45 --> 30
    Combination therapy • Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    pegylated liposomal doxorubicin • CDX-1140 • Mobista (CDX-301)
    7ms
    FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Albert Einstein College of Medicine | Completed --> Active, not recruiting | Trial completion date: Oct 2022 --> Oct 2024
    Enrollment closed • Trial completion date • Metastases
    |
    Mobista (CDX-301)
    7ms
    Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Darell Bigner | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date
    |
    lomustine • lerapolturev (PVS-RIPO)
    9ms
    Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (clinicaltrials.gov)
    P1, N=8, Completed, Istari Oncology, Inc. | Active, not recruiting --> Completed | Phase classification: P1b --> P1 | N=12 --> 8
    Trial completion • Phase classification • Enrollment change
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    lerapolturev (PVS-RIPO)
    9ms
    LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Istari Oncology, Inc. | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker • Checkpoint block • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • BRAF mutation • BRAF wild-type
    |
    lerapolturev (PVS-RIPO)
    9ms
    Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1/2, N=75, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CTAG1B (Cancer/testis antigen 1B)
    |
    PD-L1 expression • CTAG1B expression
    |
    Tecentriq (atezolizumab) • Hiltonol (poly-ICLC) • guadecitabine (SGI-110) • rasdegafusp alfa (CDX-1401)
    9ms
    LOAd703, an oncolytic virus-based immunostimulatory gene therapy, combined with chemotherapy for unresectable or metastatic pancreatic cancer (LOKON001): results from arm 1 of a non-randomised, single-centre, phase 1/2 study. (PubMed, Lancet Oncol)
    Combining LOAd703 with nab-paclitaxel plus gemcitabine in patients with advanced pancreatic ductal adenocarcinoma was feasible and safe. To build upon this novel chemoimmunotherapeutic approach, arm 2 of LOKON001, which combines LOAd703, nab-paclitaxel plus gemcitabine, and atezolizumab, is ongoing.
    P1/2 data • Clinical Trial,Phase II • Journal • Oncolytic virus • Gene therapy • Metastases
    |
    CD8 (cluster of differentiation 8) • CD40LG (CD40 ligand)
    |
    Tecentriq (atezolizumab) • gemcitabine • albumin-bound paclitaxel • delolimogene mupadenorepvec (LOAd703)
    10ms
    A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=131, Recruiting, NextCure, Inc. | Phase classification: P1b/2 --> P1/2
    Phase classification
    |
    MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • NC410
    10ms
    Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients (clinicaltrials.gov)
    P2, N=16, Terminated, Washington University School of Medicine | N=24 --> 16 | Trial completion date: Mar 2024 --> Nov 2023 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Nov 2023; Celldex decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    CDX-1140 • Mobista (CDX-301)
    10ms
    Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Darell Bigner | Initiation date: Dec 2023 --> Apr 2024
    Trial initiation date
    |
    lomustine • lerapolturev (PVS-RIPO)
    10ms
    NATASHA: Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab (clinicaltrials.gov)
    P2, N=53, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2025 --> Jan 2025 | Trial primary completion date: Oct 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • albumin-bound paclitaxel • HER-2 pulsed DC1
    10ms
    Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer (clinicaltrials.gov)
    P1/2, N=46, Active, not recruiting, Lokon Pharma AB | Trial completion date: Dec 2024 --> Aug 2024 | Trial primary completion date: Dec 2023 --> Aug 2023
    Trial completion date • Trial primary completion date • Oncolytic virus
    |
    delolimogene mupadenorepvec (LOAd703)
    10ms
    CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=15, Recruiting, Chinese PLA General Hospital | N=10 --> 15
    Enrollment change • Combination therapy • IO biomarker • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    PD-L1 expression • KRAS mutation • MSI-H/dMMR • KRAS G12C • KRAS G12D • KRAS G12V • KRAS G12
    |
    Yervoy (ipilimumab) • albumin-bound paclitaxel • cyclophosphamide • KRAS-EphA-2-CAR-DC
    11ms
    Examining Bioactivity of PVSRIPO in Invasive Breast Cancer (clinicaltrials.gov)
    P1, N=5, Completed, Istari Oncology, Inc. | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 amplification • HER-2 negative • HER-2 expression • ER expression • PGR expression
    |
    lerapolturev (PVS-RIPO)
    11ms
    Dendritic Cell Activating Scaffold in Melanoma (clinicaltrials.gov)
    P1, N=23, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    11ms
    Leukocyte-associated immunoglobulin-like receptor-1 blockade in combination with programmed death-ligand 1 targeting therapy mediates increased tumour control in mice. (PubMed, Cancer Immunol Immunother)
    However, combined targeting of LAIR-1 and PD-L1 results in increased tumour control. Thus, additional targeting of the LAIR-1:collagen pathway with NC410 is a promising approach to treating tumours where conventional immunotherapy is ineffective.
    Preclinical • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • LAIR1 (Leukocyte Associated Immunoglobulin Like Receptor 1)
    |
    LAIR1 expression
    |
    NC410
    12ms
    BRAVO: Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I) (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, University of Florida
    Trial completion date • Trial primary completion date
    |
    temozolomide • cyclophosphamide • fludarabine IV
    1year
    Lerapolturev (PVSRIPO) in GBM (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Darell Bigner
    New P2 trial
    |
    lomustine • lerapolturev (PVS-RIPO)
    1year
    Phase II study of GEN-001 in combination with avelumab in patients with PD-L1–positive locally advanced, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) who have progressed after second-line (2L) and beyond (GEN001-201 study). (ASCO-GI 2024)
    Treatment of patients with GC/GEJC with GEN-001 in combination with avelumab in the ≥ 3L setting showed promising antitumor activities with an overall manageable safety profile. The results from this trial will be updated about its effects on clinical outcome, including survival, safety, and biomarker findings. Clinical trial information: NCT05419362.
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Bavencio (avelumab) • GEN-001
    1year
    Immunization With Autologous Dendritic Cells and Tumor Lysates in Melanoma Patients (clinicaltrials.gov)
    P1/2, N=90, Completed, University of Chile
    New P1/2 trial • Tumor cell
    |
    IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • IL17A (Interleukin 17A)
    |
    IL10 elevation
    1year
    COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov)
    P3, N=195, Active, not recruiting, Canadian Cancer Trials Group | Trial primary completion date: Oct 2023 --> Apr 2024
    Trial primary completion date
    |
    IMM-101
    1year
    BRAVO: Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I) (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, University of Florida | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    temozolomide • cyclophosphamide • fludarabine IV
    1year
    Phase I trial of pegylated liposomal doxorubicin chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic triple-negative breast cancer (SABCS 2023)
    This is a single arm phase I pilot study of liposomal doxorubicin, CDX-1140 (CD40 agonist monoclonal antibody), and CDX-301 (recombinant Flt3 ligand) combination therapy in patients with metastatic or unresectable locally advanced metastatic TNBC. Key eligibility criteria are unresectable stage III or stage IV TNBC (ER ≤10%, PR ≤10%, HER2/neu negative), 1st to 3rd line treatment for metastatic disease (1st line patients need to be PD-L1 negative by 22C3 assay), measurable disease by RECIST 1.1 criteria, consent for pre-treatment and on-treatment biopsies of amenable soft tissue tumor lesions, no prior treatment with an anti-CD40 antibody or a Flt3 ligand, no anthracycline treatment in the metastatic setting, no prior progression while on anthracycline-based therapy or within 6 months of completing neoadjuvant chemotherapy, and no history of non-infectious pneumonitis or current pneumonitis. This trial will enroll up to 45 patients across multiple sites (NCT05029999) and is currently open at University of Texas Southwestern Medical Center, Texas Oncology, University of Chicago, University of Texas San Antonio, Sarah Cannon Research Institute, and Johns Hopkins.
    Combination therapy • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD40 (CD40 Molecule)
    |
    HER-2 negative • PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    pegylated liposomal doxorubicin • CDX-1140 • Mobista (CDX-301)
    1year
    Checkpoint Immunotherapy Is Associated with Preferential Activation of Tumor-Antigen Specific CD4+ T Cells in MDS (ASH 2023)
    Background: Patients with intermediate and higher-risk MDS are generally treated with the DNA hypomethylating agents (HMAs) azacytidine and decitabine...This open-label, non-randomized single center Phase 1 study used an HLA unrestricted NY-ESO-1 vaccine (CDX-1401 (1 mg) + poly-ICLC (1.8 mg)) in combination with standard dose decitabine (20mg/m2/d x 5 days) and nivolumab (3 mg/kg every 2 weeks), 4 cycles of combination therapy were planned on study; patients deriving clinical benefit could continue treatment at the discretion of the treating physician... These results suggest that the use of immunotherapy to induce effective, cytotoxic anti-tumor T cell responses depends upon the myeloid immunologic milieu in MDS patients. The critical importance of cDC1 function has recently been described and appreciated in the context of solid tumor immunotherapy. The observation of both numerical and functional defects of this cell population in patients with myeloid neoplasia provides a possible explanation for the disappointing efficacy of immunotherapies in this disease state.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • azacitidine • decitabine • Hiltonol (poly-ICLC) • rasdegafusp alfa (CDX-1401)
    1year
    GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Genome & Company | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Bavencio (avelumab) • GEN-001
    1year
    GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=148, Recruiting, Genome & Company | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • GEN-001
    over1year
    Antigen-loaded Monocyte Administration and Flt3 Ligand Augment the Antitumor Efficacy of Immune Checkpoint Blockade in a Murine Melanoma Model. (PubMed, J Immunother)
    In this study, we investigated whether monocyte vaccination in combination with CDX-301, a DC-expanding cytokine Fms-like tyrosine kinase 3 ligand (Flt3L), could improve the antitumor efficacy of anti-programmed cell death (anti-PD-1) immune checkpoint blockade...To our knowledge, this is the first demonstration that a cancer vaccine strategy and Flt3L can improve the antitumor efficacy of anti-PD-1. The findings presented here warrant further study of how monocyte vaccines can improve Flt3L and immune checkpoint blockade as they enter clinical trials.
    Preclinical • Journal • Checkpoint inhibition • Checkpoint block
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    Mobista (CDX-301)
    over1year
    Proinflammatory allogeneic dendritic cells enhance the therapeutic efficacy of systemic anti-4-1BB treatment. (PubMed, Front Immunol)
    Additionally, the combined treatment resulted in a less immunosuppressive TME, indicated by decreased infiltration of myeloid-derived suppressor cells and Tregs. These findings suggest that the combination of intratumoral AlloDCs administration with systemic agonistic α4-1BB treatment can generate a synergistic anti-tumor response, thereby warranting further investigation through clinical studies.
    Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD69 (CD69 Molecule) • ITGAE (Integrin Subunit Alpha E) • ITGA1 (Integrin Subunit Alpha 1)
    |
    Intuvax (ilixadencel)
    over1year
    NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov)
    P1, N=15, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • Proleukin (aldesleukin) • CMB305 • ID-LV305