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    DRUG:

    Proleukin (aldesleukin)

    i
    Other names: rIL-2, recombinant human interleukin-2, 125-L-Serine-2-133-interleukin 2, r-serHuIL-2
    Company:
    Clinigen, Iovance Biotherap, Merck (MSD), Novartis, Roche
    Drug class:
    IL-2 stimulant, CD122 agonist
    Related drugs:
    2d
    Aerosolized Aldesleukin in Treating Patients With Lung Metastases (clinicaltrials.gov)
    P1, N=70, Active, not recruiting, M.D. Anderson Cancer Center | Phase classification: P1/2 --> P1 | Trial completion date: Apr 2024 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2026
    Phase classification • Trial completion date • Trial primary completion date
    |
    Proleukin (aldesleukin)
    20d
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    22d
    NK4AML: Natural Killer-cell Therapy for Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=23, Recruiting, Radboud University Medical Center | Trial completion date: Sep 2023 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    IL2 (Interleukin 2)
    |
    cyclophosphamide • Proleukin (aldesleukin) • oNKord (inaleucel)
    26d
    Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    30d
    CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=16, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Apr 2024 | Trial primary completion date: Jan 2025 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2) • MLANA (Melan-A)
    |
    BRAF mutation • BRAF V600
    |
    Yervoy (ipilimumab) • cyclophosphamide • Proleukin (aldesleukin)
    1m
    Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date
    |
    cytarabine • etoposide IV • idarubicin hydrochloride • Proleukin (aldesleukin) • busulfan • Neupogen (filgrastim)
    2ms
    Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
    P1/2, N=136, Recruiting, Aulos Bioscience, Inc. | N=69 --> 136 | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Jul 2024 --> Oct 2024
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Proleukin (aldesleukin) • AU-007
    2ms
    Non-Viral TCR Gene Therapy (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=210 --> 0 | Trial completion date: Dec 2029 --> Mar 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Mar 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • IO biomarker • Gene therapy • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    2ms
    NCI-2018-01758: Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1, N=4, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Jan 2024 --> Jan 2027
    Trial completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    melphalan • Proleukin (aldesleukin)
    2ms
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    3ms
    Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
    P1, N=15, Recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Recruiting | Initiation date: May 2024 --> Jan 2024
    Enrollment open • Trial initiation date
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin) • CIML NK
    3ms
    CIML NK Cells With Venetoclax for AML (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Dana-Farber Cancer Institute | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • Proleukin (aldesleukin) • CIML NK
    3ms
    Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov)
    P1, N=210, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
    3ms
    A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Nov 2026 --> Apr 2027 | Initiation date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2025 --> Apr 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
    |
    HER-2 negative • PGR negative
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
    3ms
    Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov)
    P1, N=210, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
    3ms
    Immunotherapy for the Treatment of Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    3ms
    TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • TIDAL-01
    4ms
    Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer (clinicaltrials.gov)
    P2, N=84, Active, not recruiting, Providence Health & Services | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin)
    4ms
    Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI... (clinicaltrials.gov)
    P2, N=102, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Young TIL • ondansetron
    4ms
    Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
    P2, N=153, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • humanised dinutuximab (Hu14.18K322A)
    4ms
    Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer (clinicaltrials.gov)
    P2, N=332, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Young TIL
    4ms
    To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Inge Marie Svane
    New P1 trial • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • ADP-TILIL7
    4ms
    Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients (clinicaltrials.gov)
    P1/2, N=8, Suspended, National Cancer Institute (NCI) | N=110 --> 8 | Recruiting --> Suspended
    Enrollment change • Trial suspension • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12V • HRAS mutation • KRAS G12 • NRAS G12 • HLA-A*11 • NRAS G12V
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    4ms
    Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    BRAF V600E • BRAF V600
    |
    Zelboraf (vemurafenib) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    4ms
    Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma (clinicaltrials.gov)
    P=N/A, N=19, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    IFNG (Interferon, gamma)
    |
    cyclophosphamide • Proleukin (aldesleukin)
    5ms
    Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I/Ib Clinical Trial (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Dana-Farber Cancer Institute
    Trial initiation date
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin) • CIML NK
    5ms
    Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma (clinicaltrials.gov)
    P3, N=168, Active, not recruiting, The Netherlands Cancer Institute
    Trial completion date • Metastases
    |
    Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    5ms
    T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=8, Completed, M.D. Anderson Cancer Center | Suspended --> Completed
    Trial completion • Combination therapy
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma) • COL6A3 (Collagen Type VI Alpha 3 Chain)
    |
    PRAME expression
    |
    cyclophosphamide • Proleukin (aldesleukin) • utomilumab (PF-05082566)
    5ms
    KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer (clinicaltrials.gov)
    P1, N=42, Recruiting, Christian Hinrichs | Trial primary completion date: Sep 2023 --> Sep 2025
    Trial primary completion date • Gene therapy
    |
    cyclophosphamide • Proleukin (aldesleukin)
    5ms
    Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    5ms
    CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, M.D. Anderson Cancer Center | N=30 --> 16 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2) • MLANA (Melan-A)
    |
    BRAF mutation • BRAF V600
    |
    Yervoy (ipilimumab) • cyclophosphamide • Proleukin (aldesleukin)
    6ms
    Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis (clinicaltrials.gov)
    P1, N=15, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • oxaliplatin • leucovorin calcium • Proleukin (aldesleukin) • fluorouracil topical
    6ms
    A Phase 1 Study of Cytokine-induced Memory-like (CIML) NK Cells With Venetoclax as Consolidation Therapy in AML (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Dana-Farber Cancer Institute
    New P1 trial
    |
    Venclexta (venetoclax) • Proleukin (aldesleukin) • CIML NK
    6ms
    Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Mayo Clinic | Phase classification: P1b --> P1
    Phase classification
    |
    Opdivo (nivolumab) • oxaliplatin • leucovorin calcium • Proleukin (aldesleukin) • fluorouracil topical
    6ms
    Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I/Ib Clinical Trial (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Dana-Farber Cancer Institute
    New P1 trial
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin) • CIML NK
    6ms
    A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, University of Southern California | Trial completion date: Apr 2026 --> Nov 2026
    Trial completion date • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • PD-1 (Programmed cell death 1) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule)
    |
    HER-2 negative • PD-1 expression • PGR negative
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
    6ms
    A Prospective Randomized and Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab (clinicaltrials.gov)
    P2, N=20, Suspended, National Cancer Institute (NCI) | N=170 --> 20 | Recruiting --> Suspended
    Enrollment change • Trial suspension • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Young TIL
    6ms
    IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers (clinicaltrials.gov)
    P1/2, N=128, Recruiting, Indapta Therapeutics, INC.
    New P1/2 trial • Combination therapy • Metastases
    |
    Rituxan (rituximab) • cyclophosphamide • Darzalex (daratumumab) • fludarabine IV • mesna • IDP-023 • Proleukin (aldesleukin)
    7ms
    NYESO SCT: Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer (clinicaltrials.gov)
    P1, N=5, Terminated, Jonsson Comprehensive Cancer Center | N=12 --> 5 | Trial completion date: Aug 2024 --> Oct 2023 | Recruiting --> Terminated; slow accrual
    Enrollment change • Trial completion date • Trial termination • Metastases
    |
    CTAG1B (Cancer/testis antigen 1B) • CD34 (CD34 molecule)
    |
    fludarabine IV • Proleukin (aldesleukin) • busulfan • Neupogen (filgrastim) • plerixafor
    7ms
    NCI-2018-01758: Genetically Engineered Cells (NY-ESO-1 TCR Engineered T Cells and HSCs) After Melphalan Conditioning Regimen in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P1, N=4, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Sep 2023 --> Jan 2024
    Trial completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    CTAG1B expression
    |
    melphalan • Proleukin (aldesleukin)
    7ms
    Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=78, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2025 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Proleukin (aldesleukin)
    7ms
    E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers (clinicaltrials.gov)
    P1/2, N=15, Not yet recruiting, Christian Hinrichs | Initiation date: Apr 2023 --> Jun 2024
    Trial initiation date • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02
    |
    cyclophosphamide • Proleukin (aldesleukin)