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1m
Phase 1 study evaluating the safety, preliminary efficacy, and pharmacodynamics of recombinant interleukin-15 in combination with nivolumab and ipilimumab in patients with refractory cancers. (PubMed, J Immunother Cancer)
The combination of rhIL-15 with nivolumab and ipilimumab was safe and induced changes in immune cell populations in some patients. However, preliminary signs of efficacy were limited. Pharmacodynamic findings may support further clinical development of this combination with alternative dosing regimens or combinations of rhIL-15 with other therapeutic modalities.
P1 data • PK/PD data • Journal
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PD-1 (Programmed cell death 1) • IL15 (Interleukin 15)
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Opdivo (nivolumab) • Yervoy (ipilimumab) • rhIL-15
2ms
Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations (clinicaltrials.gov)
P1, N=24, Recruiting, Fred Hutchinson Cancer Center | Suspended --> Recruiting | Trial completion date: Feb 2026 --> Jan 2028 | Trial primary completion date: Feb 2026 --> Jan 2028
Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • NTRK (Neurotrophic receptor tyrosine kinase)
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KRAS mutation • TMB-H • BRAF mutation • HER-2 amplification • ROS1 fusion • KRAS G12 • NTRK fusion
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cyclophosphamide • bendamustine • fludarabine IV
3ms
Phase 2 trial (NCI-COTC030) of adjuvant inhaled recombinant human IL-15 combined with amputation and adjuvant chemotherapy in dogs with appendicular osteosarcoma. (PubMed, Front Immunol)
Correlative assays suggest significant immunological effects of amputation and chemotherapy on immune responses. These data have important implications on novel immunotherapy strategies involving multimodality approaches including surgery and chemotherapy.
P2 data • Journal • IO biomarker
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IL6 (Interleukin 6) • IL15 (Interleukin 15)
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rhIL-15
3ms
Trial suspension • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • NTRK (Neurotrophic receptor tyrosine kinase)
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KRAS mutation • TMB-H • BRAF mutation • HER-2 amplification • ROS1 fusion • KRAS G12 • NTRK fusion
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cyclophosphamide • bendamustine • fludarabine IV
5ms
Efficacy of VTP-300 in Chronic Hepatitis B Infection (clinicaltrials.gov)
P2, N=120, Active, not recruiting, Barinthus Biotherapeutics | Trial primary completion date: Feb 2025 --> Feb 2026
Trial primary completion date
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Opdivo (nivolumab)
5ms
KEYNOTE-E29: A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
P1, N=552, Active, not recruiting, Asher Biotherapeutics, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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Keytruda (pembrolizumab) • etakafusp alfa (AB248)
5ms
ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov)
P1/2, N=375, Recruiting, Immatics US, Inc. | Phase classification: P1 --> P1/2 | Trial completion date: Dec 2028 --> Jun 2032
Phase classification • Trial completion date
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Opdivo (nivolumab) • IMA203CD8 • anzutresgene autoleucel (IMA203)
6ms
Enrollment open
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AB821
8ms
A phase 1 study of interleukin-15 in combination with mogamulizumab in relapsed and refractory T-cell malignancies. (PubMed, Blood Neoplasia)
Recombinant human interleukin-15 (rhIL-15) is an immunotherapeutic agent that enhances natural killer (NK) cells to augment the antibody-dependent cellular cytotoxicity (ADCC) of monoclonal antibodies. Future development of combinations of immunotherapy that target the microenvironment in relapsed or refractory T-cell lymphomas remains rational. This trial was registered at www.ClinicalTrials.gov as #NCT04185220.
Clinical • P1 data • Journal
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IL15 (Interleukin 15)
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Poteligeo (mogamulizumab-kpkc) • rhIL-15