^
2d
G-CSF After Chemo-radiation in Patients with Glioblastoma (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Massachusetts General Hospital | N=40 --> 60
Enrollment change
|
temozolomide • Neupogen (filgrastim)
2d
Enrollment change
|
MUC16 (Mucin 16, Cell Surface Associated)
|
Imlygic (talimogene laherparepvec)
5d
Phase I Study of Adjuvant Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine, Low Dose Cyclophosphamide, and SBRT followed by FFX in High-Risk Resected Pancreatic Ductal Adenocarcinoma. (PubMed, Int J Radiat Oncol Biol Phys)
This is the first prospective trial to evaluate adjuvant GVAX, Cy, SBRT, and mFFX in resected PDAC patients with high-risk features. This combination regimen was well tolerated with limited toxicity and promising survival outcomes, warranting future studies to validate this regimen in the adjuvant setting.
P1 data • Journal • Tumor cell
|
CSF2 (Colony stimulating factor 2)
|
5-fluorouracil • cyclophosphamide • irinotecan • leucovorin calcium • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
5d
Repair Assisted Damage Detection (RADD) as a predictive biomarker for immunotherapy response in ovarian cancer. (PubMed, Gynecol Oncol)
RADD revealed DNA repair proficiency without mutation signatures or expression profiling. High DNA damage levels show improved survival for Vigil maintenance therapies and are correlated with immune evasion proteins. The persistence of DNA lesions in the genomic DNA offers a new biomarker for immunotherapy patient stratification.
Journal • IO biomarker
|
ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
|
ENTPD1 expression
|
Vigil (gemogenovatucel-T)
6d
G-CSF After Chemo-radiation in Patients with Glioblastoma (clinicaltrials.gov)
P2, N=40, Not yet recruiting, Massachusetts General Hospital | N=60 --> 40
Enrollment change
|
temozolomide • Neupogen (filgrastim)
7d
Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery (clinicaltrials.gov)
P2, N=40, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • IO biomarker • Surgery
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Imlygic (talimogene laherparepvec)
14d
Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma (clinicaltrials.gov)
P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=24 --> 0 | Trial completion date: Dec 2029 --> Nov 2024 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2029 --> Nov 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
|
CD4 (CD4 Molecule)
|
paclitaxel • Neupogen (filgrastim)
16d
Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease (clinicaltrials.gov)
P1, N=11, Completed, University of Nebraska | Active, not recruiting --> Completed
Trial completion
|
Leukine (sargramostim)
16d
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov)
P2, N=62, Recruiting, New Approaches to Neuroblastoma Therapy Consortium | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
24d
Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients with Metastatic Melanoma to the Lung (clinicaltrials.gov)
P1, N=0, Withdrawn, Mayo Clinic | N=24 --> 0 | Trial completion date: Jul 2025 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2025 --> Oct 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • Leukine (sargramostim)
24d
Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide in Multiple Myeloma Patients in Complete or Near Complete Remission (clinicaltrials.gov)
P2, N=54, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Sep 2024 --> Dec 2024
Trial completion date
|
lenalidomide • allogeneic Myeloma GM-CSF Vaccine
25d
New P1 trial • Metastases
|
Imlygic (talimogene laherparepvec)
25d
Trial completion date
|
cisplatin • carboplatin • cyclophosphamide • etoposide IV • vincristine • mesna • Neupogen (filgrastim)
1m
MP-11: Moderated Oral ePoster Session: Kidney and Ureteral Cancer - Clinical (SIU 2024)
MP-10.01 Diffusion-Weighted Magnetic Resonance Imaging for Assessment of Tumor Response in Muscle-Invasive Bladder Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Prospective StudyAbbas Basiri, Iran, Islamic Rep. MP-10.02 Divergent Experiences of Bladder Cancer Patients: A Focus on Advanced and Metastatic Disease StagesAlex Filicevas, Belgium MP-10.03 Evolution of a Rapid, Simple Urine Test for Detecting Volatile Organic Compound (VOC) in Urine by a High Performance Portable Device (NABIL) for Detection of Urinary Bladder CarcinomaSaurav Karmakar, India MP-10.04 Intraoperative ICG Fluorescence as a Method of Prevention of Postoperative Strictures of Uretero-Ileoanastomoses During Robot-Assisted Radical CystectomyValentin Pavlov, Russian Federation MP-10.05 Intravesical Gemcitabine and Docetaxel in Patients with High Risk NMIBC: Our ExperienceDeepak Krishnappa, India MP-10.06 On Block Robot-Assisted Radical Cystectomy: New Method for Bladder CancerValentin Pavlov, Russian Federation MP-10.07 Oncological Outcomes with the 80mg Dose of the Moscow Strain of Intravesical BCG for Non-Muscle Invasive Bladder Cancer: Implications for Global ShortageAmandeep Arora, India MP-10.08 Outcome of Robot-Assisted Radical Cystectomy with Intracorporeal Creation of Heterotopic NeocystisValentin Pavlov, Russian Federation MP-10.09 Proposed Novel Surveillance Schedule Using Cx Monitor for Patients on Annual Bladder Cancer SurveillanceArjun Guduguntla, Australia MP-10.10 Quality of Primary TURBTs for Non-Muscle Invasive Bladder Cancer PatientsSaurabh Verma, United Kingdom MP-10.11 TAR-200 in Patients with Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results from the SunRISe-1 StudyAndrea Necchi, United States MP-10.12 Timeline Analysis of Muscle Invasive Bladder Cancer PatientsSaurabh Verma, United Kingdom MP-10.13 Transurethral Resection of Bladder Tumour (TURBT) Operative Notes: How to Improve Their QualitySaurabh Verma, United Kingdom MP-10.14 Trial in Progress: PIVOT-006- A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer Following Transurethral Resection of Bladder TumorRobert Svatek, United States MP-10.15 URO17® Urine Test For Bladder Cancer - Meta AnalysisNikhil Vasdev, United Kingdom MP-10.16 Usefulness of UF-5000 Automatic Screening System in Urothelial Carcinoma DiagnosisTadahiko Kikugawa, Japan MP-10.17 Validation of Novel ddPCR Bladder Cancer DNA Mutation Panels in Liquid BiopsiesAntara Karmakar, Australia
Clinical
|
URO17™
|
docetaxel • GemRIS (gemcitabine-releasing intravesical system) • cretostimogene grenadenorepvec (CG0070)
1m
Trial completion date • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
1m
Trial completion date
|
cisplatin • carboplatin • cyclophosphamide • etoposide IV • vincristine • thiotepa • Neupogen (filgrastim)
1m
G-CSF After Chemo-radiation in Patients with Glioblastoma (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Massachusetts General Hospital
New P2 trial
|
temozolomide • Neupogen (filgrastim)
1m
Genetic Factors Associated with Clinical Response in Melanoma Patients Treated with Talimogene Laherparapvec: A Single-Institution Retrospective Analysis. (PubMed, Ann Surg Oncol)
This work describes the experience using T-VEC in melanoma at a single institution and highlights the presence of TERT promotor mutations as a possible driver of clinical response.
Retrospective data • Journal • IO biomarker
|
TERT (Telomerase Reverse Transcriptase)
|
TERT mutation
|
Imlygic (talimogene laherparepvec)
1m
NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
|
MYCN amplification • IL6 expression
|
cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
1m
GM-CSF With Post-Transplant Cyclophosphamide (clinicaltrials.gov)
P2, N=38, Recruiting, Northside Hospital, Inc. | Trial primary completion date: Sep 2024 --> Sep 2025
Trial primary completion date • Post-transplantation
|
cyclophosphamide • Leukine (sargramostim)
1m
IMPALA-2: Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) (clinicaltrials.gov)
P3, N=160, Active, not recruiting, Savara Inc. | Trial completion date: Jun 2025 --> Nov 2024 | Trial primary completion date: Jun 2024 --> Nov 2023
Trial completion date • Trial primary completion date
2ms
Enrollment open
|
cretostimogene grenadenorepvec (CG0070)
2ms
Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection (clinicaltrials.gov)
P=N/A, N=300, Recruiting, Amgen | Trial completion date: Aug 2038 --> Jan 2038 | Trial primary completion date: Aug 2038 --> Jan 2038
Trial completion date • Trial primary completion date
|
Imlygic (talimogene laherparepvec)
2ms
Biomarker Assessments of Leukine During Treatment of Parkinson's Disease (clinicaltrials.gov)
P1, N=7, Completed, University of Nebraska | Active, not recruiting --> Completed
Trial completion
|
Leukine (sargramostim)
2ms
SESAD: Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (clinicaltrials.gov)
P2, N=42, Recruiting, University of Colorado, Denver | Trial completion date: Jul 2025 --> Oct 2026 | Trial primary completion date: Jul 2025 --> Apr 2026
Trial completion date • Trial primary completion date
|
Leukine (sargramostim)
2ms
Intrauterine Infusion of GCSF and Reproductive Outcomes in Infertile Women with History of RIF (clinicaltrials.gov)
P=N/A, N=100, Completed, Cairo University | Recruiting --> Completed | Trial completion date: Nov 2023 --> Sep 2024 | Trial primary completion date: Oct 2023 --> Aug 2024
Trial completion • Trial completion date • Trial primary completion date
|
Neupogen (filgrastim)
2ms
Keynote 935: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (clinicaltrials.gov)
P2, N=35, Completed, CG Oncology, Inc. | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> May 2024
Trial completion • Trial completion date • Combination therapy
|
Keytruda (pembrolizumab) • cretostimogene grenadenorepvec (CG0070)
2ms
Continuous Versus Bolus Administration of G-CSF in Children With Cancer (clinicaltrials.gov)
P4, N=20, Active, not recruiting, Chang Gung Memorial Hospital | Recruiting --> Active, not recruiting | N=40 --> 20
Enrollment closed • Enrollment change
|
Granocyte (lenograstim) • Neupogen (filgrastim)
2ms
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
P2, N=270, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
Trial completion date • Trial primary completion date
|
cytarabine • decitabine • Mylotarg (gemtuzumab ozogamicin) • idarubicin hydrochloride • fludarabine IV • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate)
3ms
Spatial Analysis of Tumor-Infiltrating Lymphocytes in mRCC Patients Treated with Pexa-Vec (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) and cemiplimab (REGN2810; Anti-PD-1) (EORTC-NCI-AACR 2024)
AI-powered spatial analysis suggests that combination therapy with Pexa-vec and cemiplimab enhances the immune response, evidenced by increased TIL densities in the tumor microenvironment.Table 1: Changes in TIL Densities from Pre- to Post-TreatmentMeasureCohortPre-Treatment (mm²)(Median, IQR)Post-Treatment (mm²)(Median, IQR)p-value isTILOverall (n = 18)87.53 (179.37-114.65)214.02 (257.50-389.74)0.0040 Arm A (n = 9)41.30 (257.13-81.61)190.17 (830.30-389.34)0.0078 Arm B (n = 9)165.43 (180.52-147.69)390.17 (340.11-387.14)0.1641iTILOverall (n = 18)88.89 (129.08-116.99)161.11 (376.62-321.79)0.0237 Arm A (n = 9)56.42 (125.56-101.70)157.44 (421.03-469.55)0.0273 Arm B (n = 9)96.27 (57.33-132.29)154.92 (194.87-184.03)0.3716sTILOverall (n = 18)100.91 (291.38-193.61)219.37 (370.85-466.27)0.0599 Arm A (n = 9)35.59 (257.13-67.38)140.55 (286.46-157.15)0.0391 Arm B (n = 9)303.37 (171.24-319.84)353.58 (189.15-735.39)0.4961
Clinical • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
|
CSF2 (Colony stimulating factor 2)
|
Lunit SCOPE IO
|
Libtayo (cemiplimab-rwlc) • Pexa-Vec (pexastimogene devacirepvec)
3ms
New P2 trial
|
cretostimogene grenadenorepvec (CG0070)
3ms
Off-the-shelf NK Cells + SCT for Myeloid Malignancies (clinicaltrials.gov)
P1/2, N=24, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jun 2026
Trial completion date • Trial primary completion date • Combination therapy
|
TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • KMT2A (Lysine Methyltransferase 2A) • MECOM (MDS1 And EVI1 Complex Locus) • NUP214 (Nucleoporin 214) • GATA2 (GATA Binding Protein 2) • DEK (DEK Proto-Oncogene)
|
cyclophosphamide • melphalan • fludarabine IV • mesna • Neupogen (filgrastim)
3ms
Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas (clinicaltrials.gov)
P2, N=19, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | Phase classification: PN/A --> P2 | Trial completion date: Sep 2024 --> Oct 2023 | Trial primary completion date: Sep 2024 --> Oct 2023
Trial completion • Phase classification • Trial completion date • Trial primary completion date • Tumor cell
|
5-fluorouracil • cyclophosphamide • oxaliplatin • irinotecan • leucovorin calcium • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
3ms
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
P1/2, N=30, Recruiting, Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Oncolytic virus
|
BS001
3ms
OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer (clinicaltrials.gov)
P2, N=45, Recruiting, Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Oncolytic virus • Metastases
|
BS001
4ms
New trial
4ms
Phase classification • Combination therapy • Pan tumor • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
Keytruda (pembrolizumab) • Imlygic (talimogene laherparepvec)
4ms
A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine (clinicaltrials.gov)
P2, N=71, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2024 --> Jul 2025
Trial completion date • Tumor cell
|
cyclophosphamide • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells)
4ms
Gemogenovatucel-T (Vigil): bi-shRNA plasmid-based targeted immunotherapy. (PubMed, Future Oncol)
Transfected plasmid components contain an expressive human GMCSF DNA segment to enhance anticancer immune functional response and a second component expressing bi-shRNAfurin which reduces TGFβ isomers (TGFβ1 and TGFβ2) thereby reducing cancer inhibition of the targeted immune response. Results generated to date justify advancement to confirmatory clinical trials supporting product regulatory approval.
Review • Journal
|
TGFB1 (Transforming Growth Factor Beta 1) • FURIN (Furin, Paired Basic Amino Acid Cleaving Enzyme) • TGFB2 (Transforming Growth Factor Beta 2)
|
Vigil (gemogenovatucel-T)
4ms
Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors (clinicaltrials.gov)
P2, N=132, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Jan 2028 --> Oct 2028 | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jan 2027 --> Oct 2027
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine) • Leukine (sargramostim)
4ms
Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung (clinicaltrials.gov)
P1, N=24, Not yet recruiting, Mayo Clinic | Trial completion date: Apr 2025 --> Jul 2025 | Trial primary completion date: Apr 2025 --> Jul 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • Leukine (sargramostim)
4ms
New P2 trial
|
carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • irinotecan • vincristine • topotecan • Danyelza (naxitamab-gqgk) • Leukine (sargramostim)