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DRUG CLASS:

IL-2 stimulant

8d
A534260: IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (clinicaltrials.gov)
P1/2, N=8, Terminated, University of Wisconsin, Madison | Trial completion date: Aug 2026 --> Dec 2025 | Active, not recruiting --> Terminated; Administrative
Trial completion date • Trial termination
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Opdivo (nivolumab) • Yervoy (ipilimumab) • lorukafusp alfa (APN301)
8d
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC) (clinicaltrials.gov)
P2, N=180, Recruiting, Philogen S.p.A. | Not yet recruiting --> Recruiting | Initiation date: Feb 2026 --> Jun 2026
Enrollment open • Trial initiation date
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
12d
HCC 21-166: T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=25, Active, not recruiting, Alexander B Olawaiye, MD | Recruiting --> Active, not recruiting | N=70 --> 25 | Trial completion date: Dec 2027 --> Dec 2030 | Trial primary completion date: Dec 2025 --> May 2030
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Checkpoint inhibition
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MSI (Microsatellite instability) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
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MSI-H/dMMR
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Keytruda (pembrolizumab) • Lymphir (denileukin diftitox-cxdl)
14d
Immune Correlates of Denileukin Diftitox Treatment in TFH-Type Lymphoma. (PubMed, Cancers (Basel))
TFH-type lymphomas were associated with higher FOXP3-positive cell density than selected non-TFH-type comparators. DD treatment may be associated with changes in tissue immune infiltrates and peripheral CD8/TCR Vβ skewing in responding cases, although these findings remain exploratory and do not establish causality.
Journal • IO biomarker
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CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • CD4 (CD4 Molecule) • CD68 (CD68 Molecule) • FOXP3 (Forkhead Box P3)
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Ontak (denileukin diftitox)
19d
ANEMIL: Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment (clinicaltrials.gov)
P1/2, N=2, Terminated, University Hospital, Bordeaux | Completed --> Terminated; target number of inclusion not reached
Trial termination
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Proleukin (aldesleukin)
19d
Phase 1/2 study of pegenzileukin, a pegylated recombinant non-alpha IL-2, with cemiplimab for the treatment of advanced unresectable or metastatic skin cancers. (PubMed, J Immunother Cancer)
Pegenzileukin in combination with cemiplimab at the RP2D of 16 µg/kg showed a manageable safety profile and promising translational data supporting its mechanism of action.
Clinical • P1/2 data • Journal • PD(L)-1 Biomarker • First-in-human
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CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
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Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • pegenzileukin (SAR444245)
22d
19-C-0017: Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients (clinicaltrials.gov)
P1/2, N=5, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Study was closed due to lack of accrual and study outcomes overlapped with another protocol's eligibility.
Trial termination • IO biomarker
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PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
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PD-L1 expression • KRAS mutation • NRAS mutation • KRAS G12D • HRAS mutation • KRAS G12 • NRAS G12
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cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
24d
Fully intravenous split-dose administration of the oncolytic adenovirus TILT-123 in advanced solid tumors. (PubMed, Mol Ther)
Post-treatment biopsies confirmed virus presence and alterations in immune cell composition. These findings support further evaluation of intravenous TILT-123 administration in clinical trials.
Journal • IO biomarker
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TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
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igrelimogene litadenorepvec (TILT-123)
25d
Safety, pharmacokinetics, pharmacodynamics, and antitumor activity of cergutuzumab amunaleukin: a phase I study in patients with advanced and/or metastatic solid tumors. (PubMed, ESMO Open)
Consistent with its mechanism of action, CA had a manageable safety profile and expanded immune effector cells but not Treg. Further development in combination with additional immunomodulatory agents is warranted.
P1 data • PK/PD data • Journal • First-in-human
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CD8 (cluster of differentiation 8) • CEACAM5 (CEA Cell Adhesion Molecule 5) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2)
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cergutuzumab amunaleukin (RG7813)
27d
ALaDIN: Use of Low Doses of Interleukin-2 in Autism Spectrum Disorders (clinicaltrials.gov)
P2, N=22, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
New P2 trial
1m
First-In-Human Trial of Encapsulated Cells Constitutively Expressing Localized IL-2 in Patients with High-Grade Serous Ovarian Carcinoma. (PubMed, Clin Cancer Res)
In patients with HGSOC, AVB-001 is safe and effectively activates cytotoxic T cells, supporting further investigation of this locoregional immunotherapy.
P1 data • Journal • PD(L)-1 Biomarker • IO biomarker • First-in-human
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
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AVB-001
1m
CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs (clinicaltrials.gov)
P2, N=30, Recruiting, Yale University | Not yet recruiting --> Recruiting
Enrollment open
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PD-L1 (Programmed death ligand 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
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Keytruda (pembrolizumab) • CUE-101