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DRUG CLASS:

IL-15 superagonist

25d
3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov)
P1, N=28, Active, not recruiting, Rockefeller University | Recruiting --> Active, not recruiting
Enrollment closed
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CD4 (CD4 Molecule)
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Anktiva (nogapendekin alfa inbakicept-pmln)
28d
QUILT-88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
P2, N=328, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Metastases
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gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
1m
Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate. (PubMed, Oncologist)
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 α-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.
Journal
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL15 (Interleukin 15)
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Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
1m
Nanoenabled IL-15 Superagonist via Conditionally Stabilized Protein-Protein Interactions Eradicates Solid Tumors by Precise Immunomodulation. (PubMed, J Am Chem Soc)
In murine colon cancer models, Nano-SA achieved potent immunotherapeutic effects, eradicating tumors without adverse side effects. These findings highlight the transformative potential of nanotechnology for advancing protein complex-based therapies.
Journal • Immunomodulating
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IL15 (Interleukin 15)
2ms
QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=19, Terminated, Altor BioScience | Phase classification: P1/2 --> P1 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Phase classification • Trial termination
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Anktiva (nogapendekin alfa inbakicept-pmln)
2ms
Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis (clinicaltrials.gov)
P1, N=10, Completed, ImmunityBio, Inc. | Recruiting --> Completed | Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2024 --> Sep 2024
Trial completion • Trial completion date • Trial primary completion date
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NCAM1 (Neural cell adhesion molecule 1)
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Anktiva (nogapendekin alfa inbakicept-pmln)
2ms
AURELIO-03: Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial primary completion date: Aug 2024 --> Dec 2024
Trial primary completion date • Combination therapy • Metastases
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Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
2ms
Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19 (clinicaltrials.gov)
P1, N=1, Terminated, ImmunityBio, Inc. | 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 • Trial termination • Immunomodulating
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Anktiva (nogapendekin alfa inbakicept-pmln)
3ms
Trial primary completion date • Metastases
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gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
3ms
QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
P2, N=147, Active, not recruiting, ImmunityBio, Inc. | Phase classification: P2b --> P2 | Trial completion date: Dec 2024 --> Dec 2030 | Trial primary completion date: May 2024 --> Aug 2029
Phase classification • Trial completion date • Trial primary completion date • Checkpoint inhibition
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
3ms
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov)
P2, N=186, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2027 --> Feb 2027
Trial completion date
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MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • EPCAM (Epithelial cell adhesion molecule)
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Anktiva (nogapendekin alfa inbakicept-pmln) • Tri-Ad5
3ms
KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
P2, N=166, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2025 --> Nov 2024 | Trial primary completion date: Sep 2025 --> Aug 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
3ms
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)
P1/2, N=3, Terminated, NantCell, Inc. | 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.
Phase classification • Trial termination • Combination therapy
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Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011
4ms
AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
P2, N=16, Terminated, SOTIO Biotech AG | N=52 --> 16 | Trial completion date: Nov 2024 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Mar 2024; Due to lack of efficacy shown at the time of the interim analysis.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
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Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
4ms
First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study (clinicaltrials.gov)
P1, N=18, Recruiting, Suzhou Forlong Biotechnology Co.,Ltd, | Active, not recruiting --> Recruiting
Enrollment open • Metastases
4ms
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov)
P2, N=186, Recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2027 --> Jul 2027
Trial completion date
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MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • EPCAM (Epithelial cell adhesion molecule)
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Anktiva (nogapendekin alfa inbakicept-pmln) • Tri-Ad5
4ms
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov)
P2, N=20, Recruiting, ImmunityBio, Inc. | Not yet recruiting --> Recruiting
Enrollment open
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IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
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Avastin (bevacizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
4ms
Nogapendekin alfa Inbakicept: First Approval. (PubMed, Drugs)
In April 2024, nogapendekin alfa inbakicept was approved for use with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours in the USA. This article summarizes the milestones in the development of nogapendekin alfa inbakicept leading to this first approval for the treatment of cancer.
Review • Journal
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IL15 (Interleukin 15)
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Anktiva (nogapendekin alfa inbakicept-pmln)
4ms
Trial suspension
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PD-L1 (Programmed death ligand 1)
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Anktiva (nogapendekin alfa inbakicept-pmln) • H1299 lung cancer cell lysate vaccine with Montanide ISA-51 VG adjuvant
5ms
Enrollment open • Combination therapy • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Anktiva (nogapendekin alfa inbakicept-pmln)
5ms
Efficiently targeting neuroblastoma with the combination of anti-ROR1 CAR NK cells and N-803 in vitro and in vivo in NB xenografts. (PubMed, Mol Ther Oncol)
In vivo, anti-ROR1 CAR exPBNK plus N-803 significantly (p < 0.05) enhanced survival in human ROR1+ NB xenografted NSG mice compared to anti-ROR1 CAR exPBNK alone. Our results provide the rationale for further development of anti-ROR1 CAR exPBNK cells plus N-803 as a novel combination immunotherapeutic for patients with recurrent and/or refractory ROR1+ NB.
Preclinical • Journal
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ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
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Anktiva (nogapendekin alfa inbakicept-pmln)
5ms
Phase classification • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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cyclophosphamide • Trodelvy (sacituzumab govitecan-hziy) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
5ms
KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
P2, N=166, Active, not recruiting, SOTIO Biotech AG | N=320 --> 166 | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Sep 2025
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
6ms
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=20, Recruiting, ImmunityBio, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
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Rituxan (rituximab) • cyclophosphamide • fludarabine IV • Anktiva (nogapendekin alfa inbakicept-pmln) • CD19.t-haNK
6ms
Trial suspension
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Anktiva (nogapendekin alfa inbakicept-pmln)
6ms
Enrollment open • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
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Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC) (clinicaltrials.gov)
P2, N=7, Terminated, ImmunityBio, Inc. | N=24 --> 7 | Unknown status --> Terminated
Enrollment change • Trial termination • Combination therapy • Metastases
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Anktiva (nogapendekin alfa inbakicept-pmln) • Neukoplast (CST-101)
7ms
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov)
P1/2, N=53, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=113 --> 53
Enrollment closed • Enrollment change
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TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
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TMB-H • MSI-H/dMMR
|
bintrafusp alfa (M7824) • epacadostat (INCB024360) • Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov)
P1/2, N=596, Recruiting, ImmunityBio, Inc. | Trial completion date: Dec 2027 --> Dec 2038 | Trial primary completion date: Dec 2025 --> Dec 2028
Trial completion date • Trial primary completion date • Combination therapy
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Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
Enrollment closed • Combination therapy
|
Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
Enrollment change
|
CD4 (CD4 Molecule)
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Anktiva (nogapendekin alfa inbakicept-pmln)
7ms
N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=28 --> 0 | Trial completion date: Aug 2026 --> Apr 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2024 --> Apr 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy
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CD4 (CD4 Molecule)
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bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
New P1 trial • Combination therapy
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Anktiva (nogapendekin alfa inbakicept-pmln) • CIML NK
8ms
Enrollment open • Metastases
|
Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
8ms
QUILT-505: PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC (clinicaltrials.gov)
P2, N=25, Recruiting, Glenn J. Hanna | Not yet recruiting --> Recruiting
Enrollment open • Metastases
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Erbitux (cetuximab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
9ms
Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
P=N/A, N=6, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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Anktiva (nogapendekin alfa inbakicept-pmln)
9ms
QUILT2023: QUILT 2.023: A Study of N-803 in Combination With Current Standard of Care vs Standard of Care as First-Line Treatment for Patients With Stage 3 or 4 NSCLC. (clinicaltrials.gov)
P3, N=1538, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Jul 2024 --> Apr 2026 | Trial primary completion date: Jul 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
PD-L1 expression • EGFR mutation • BRAF mutation • ALK translocation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Anktiva (nogapendekin alfa inbakicept-pmln)
9ms
New P2 trial • Metastases
|
Erbitux (cetuximab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
9ms
New P1/2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Anktiva (nogapendekin alfa inbakicept-pmln)
9ms
An Interleukin-15 Superagonist with BCG - A Major Therapeutic Advancement or Just a Small Step in the Right Direction? (PubMed, NEJM Evid)
For more than 40 years, intravesical Bacillus Calmette-Guérin (BCG) has remained the most effective treatment for non-muscle-invasive bladder cancer (NMIBC); however, tumor recurrence and progression are common, especially for those patients with carcinoma in situ (CIS).1 Therapeutic options are limited when treatment with BCG fails, and radical cystectomy remains the only curative treatment. BCG-unresponsive NMIBC criteria were developed in 2015 to identify patients for whom additional BCG would likely not be effective and to facilitate clinical trials of novel therapies.2,3.
Journal
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IL15 (Interleukin 15)
10ms
Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=20, Not yet recruiting, ImmunityBio, Inc. | Trial completion date: Sep 2026 --> Mar 2027 | Trial primary completion date: Sep 2024 --> Mar 2026
Trial completion date • Trial primary completion date • Combination therapy
|
CD20 positive
|
Rituxan (rituximab) • cyclophosphamide • fludarabine IV • Anktiva (nogapendekin alfa inbakicept-pmln) • CD19.t-haNK
10ms
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov)
P2, N=186, Recruiting, National Cancer Institute (NCI) | Phase classification: P2b --> P2
Phase classification
|
MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • EPCAM (Epithelial cell adhesion molecule)
|
Anktiva (nogapendekin alfa inbakicept-pmln) • Tri-Ad5