- |||||||||| CIML NK - Dana / Farber Cancer Institute
Trial completion, Combination therapy, Metastases, Immune cell: CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) - Dec 18, 2024 P1, N=11, Completed, The abstract will be released to the public on February 10, 2025 at 2:00 PM PST Active, not recruiting --> Completed
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal: Bladder-sparing Therapy for Bacillus Calmette-Gu (Pubmed Central) - Dec 12, 2024 Active, not recruiting --> Recruiting | N=147 --> 40 The IBCG consensus recommendations provide practical guidance on BST for BCG-U NMIBC.
- |||||||||| epirubicin / Generic mfg., Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Journal: Engineered VNP20009 expressing IL-15&15R? augments anti-tumor immunity for bladder cancer treatment. (Pubmed Central) - Dec 7, 2024 Moreover, the sequential intravesical instillation of epirubicin (EPI), a first-line bladder cancer drug, followed by thermally activated 15&15R?@VNP, could achieve further improved therapeutic responses, without causing significant side effects. Therefore, this study shows that 15&15R?@VNP can be effectively used in the treatment of bladder cancer and can be used as a complementary therapy to chemotherapy agents, promising for potential clinical translation in bladder cancer treatment.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Unmet Need in Non-muscle-invasive Bladder Cancer Failing Bacillus Calmette-Gu (Pubmed Central) - Nov 18, 2024 In the rapidly evolving landscape of urothelial cancer, some of these treatment strategies might be cost effective and improve patients' quality of life. The findings of our review highlight the need for novel, more effective therapeutic strategies.
- |||||||||| Balversa (erdafitinib) / J&J, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Journal: Comparison between N-803 and Erdafitinib in Bacillus Calmette-Gu (Pubmed Central) - Oct 26, 2024 Not yet recruiting --> Recruiting Bladder cancer, the sixth most common cancer and the tenth leading cause of cancer-related death worldwide, remains a significant global health concern [...].
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Enrollment closed: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Oct 20, 2024 P1, N=28, Active, not recruiting, Our results suggest that Isotretinoin can be a novel approach to target and eliminate translation-competent HIV reservoirs. Recruiting --> Active, not recruiting
- |||||||||| Journal: Novel intravesical therapies and delivery systems for the management of bladder cancer. (Pubmed Central) - Oct 8, 2024
The armamentarium for the treatment of bladder cancer patients is expanding, notably with HIVEC, hydrogels, drug-RIS and novel therapies. However, accurate patients' selection is key to prevent disease progression in any bladder-sparing strategy, and radical cystectomy remains the gold-standard to date.
- |||||||||| PD-L1.t-haNK / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Journal: Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate. (Pubmed Central) - Oct 7, 2024 The epidermal growth factor receptor-targeted antibody-nanocell conjugate E-EDV-D682 provides tumor-targeted chemotherapy in the form of its anthracycline metabolite PNU159682 (nemorubicin) cargo and is currently being studied in combination with immunomodulatory EDVs delivering the adjuvant ?-galactosyl ceramide (GC)...Under the initial single-patient Investigational New Drug (spIND) protocol, the patient received N-803, PD-L1 t-haNK cells, and the albumin doxorubicin conjugate aldoxorubicin for ~27 months...Due to progression, a second spIND protocol was designed whereby the patient received E-EDV-D682 plus EDV-GC for more than 24 months, which resulted in stable disease and the patient's continued survival at the time this report was written. The patient's extended survival despite the dire prognosis associated with recurrent mPC points to the merits of this temporal combination regimen in overcoming immuno-chemo resistance with enhanced immune activity required for tumor response and extended survival.
- |||||||||| Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal: Recent Advances in Drug Delivery Strategies for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: A Brief Review from 2018 to 2024. (Pubmed Central) - Sep 29, 2024 This review focuses on high-risk BCG-unresponsive NMIBC therapies that have been or are currently being investigated in clinical trials, offering a broad overview of the delivery system designs and up-to-date clinical outcomes that have been reported as of July 2024. It aims to inform the development of future drug delivery systems for second-line therapies in high-risk BCG-unresponsive NMIBC.
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Phase classification, Trial termination: QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Sep 25, 2024 P1, N=19, Terminated, Not yet recruiting --> Recruiting Phase classification: P1/2 --> P1 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- |||||||||| CIML NK - Dana / Farber Cancer Institute
Enrollment closed, Enrollment change, Combination therapy, Metastases, Immune cell: CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) - Sep 19, 2024 P1, N=11, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Aug 2024 Recruiting --> Active, not recruiting | N=25 --> 11
- |||||||||| Phase classification, Enrollment change, Trial termination: QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - Aug 27, 2024
P1/2, N=3, Terminated, Phase classification: P1b --> P1 | Active, not recruiting --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Phase classification: P1b/2 --> P1/2 | N=173 --> 3 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- |||||||||| Tri-Ad5 / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date: Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - Aug 9, 2024 P2, N=186, Recruiting, Phase classification: P2b --> P2 | Trial completion date: Dec 2024 --> Dec 2030 | Trial primary completion date: May 2024 --> Aug 2029 Trial completion date: Jul 2027 --> Feb 2027
- |||||||||| ETBX-011 / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Phase classification, Trial termination, Combination therapy: QUILT-3.040t: QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer (clinicaltrials.gov) - Aug 6, 2024 P1/2, N=3, Terminated, PTC was observed only in animals receiving SIV RhmAbs and SIV RhmAbs+CD8a-depletion+N-803, likely explained by treatment-induced changes in the T cell transcriptome towards an activated and antiviral state. Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; The study was terminated before any dose escalation occurred in order to pursue other studies designed to more extensively evaluate the combination of ETBX-011 and N-803 along with other immunotherapy agents.
- |||||||||| Enrollment change, Trial termination: QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov) - Aug 5, 2024
P1/2, N=4, Terminated, Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; The study was terminated before any dose escalation occurred in order to pursue other studies designed to more extensively evaluate the combination of ETBX-011 and N-803 along with other immunotherapy agents. N=65 --> 4 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
- |||||||||| CIML NK - Dana / Farber Cancer Institute
Trial initiation date, Trial primary completion date, Combination therapy: Memory-like Natural Killer (NK) Cell Therapy in Patients with Renal Cell Carcinoma or Urothelial Carcinoma (clinicaltrials.gov) - Jul 30, 2024 P1, N=5, Not yet recruiting, N=65 --> 4 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Dec 2025
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
IL15 Superagonist (N-803, Anktiva) + Checkpoint Inhibitor (CPI) Prolongs OS in 2ndline or Greater NSCLC Patients Failing CPI (20BC) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_871; The KM curve demonstrates long-term survival at ?18 and ?21 months of 28/86 (33%) and 26/86 (30%) patients respectively: Conclusions : Anktiva plus CPI therapy in 2 nd line or greater NSCLC demonstrated long-term median OS, independent of PDL1 status, and independent of prior lines of therapy in patients with acquired resistance to CPI. These findings support the novel mechanism of action of Anktiva to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median OS ongoing survival of 33% and 30% at 18 and 21 months respectively, exceeding the standard of care.
- |||||||||| Tri-Ad5 / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date: Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - Jul 23, 2024 P2, N=186, Recruiting, These findings support the novel mechanism of action of Anktiva to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median OS ongoing survival of 33% and 30% at 18 and 21 months respectively, exceeding the standard of care. Trial completion date: Feb 2027 --> Jul 2027
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal: Nogapendekin alfa Inbakicept: First Approval. (Pubmed Central) - Jul 5, 2024 Not yet recruiting --> Recruiting In April 2024, nogapendekin alfa inbakicept was approved for use with Bacillus Calmette-Gu
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Review, Journal: N-803 Plus BCG Treatment for BCG-Na (Pubmed Central) - Jul 2, 2024 P1/2, P2/3 N-803 used alone was only effective in 2 of 10 participants. In both studies, the combination of N-803 and BCG was found to be associated with very few adverse events.Based on results from the Phase 2/3 study, the U.S. Food and Drug Association (FDA) approved the use of N-803 plus BCG for the treatment of BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease.Clinical Trial Registration: NCT02138734 (Phase 1b study), NCT03022825 (Phase 2/3 study).
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment open, Metastases: QUILT 502: Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer (clinicaltrials.gov) - Jun 27, 2024 P1/2, N=60, Recruiting, In both studies, the combination of N-803 and BCG was found to be associated with very few adverse events.Based on results from the Phase 2/3 study, the U.S. Food and Drug Association (FDA) approved the use of N-803 plus BCG for the treatment of BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease.Clinical Trial Registration: NCT02138734 (Phase 1b study), NCT03022825 (Phase 2/3 study). Suspended --> Recruiting
- |||||||||| CIML NK - Dana / Farber Cancer Institute
Trial completion date, Trial primary completion date, Combination therapy, Metastases, Immune cell: CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) - Jun 16, 2024 P1, N=25, Recruiting, No abstract available Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Sep 2024
- |||||||||| CD19.t-haNK / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment open, Combination therapy: Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma (clinicaltrials.gov) - May 29, 2024 P1, N=20, Recruiting, Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention Not yet recruiting --> Recruiting
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