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    DRUG:

    CS1002 (ipilimumab biosimilar)

    i
    Company:
    CStone Pharma, Jiangsu Hengrui Pharma
    Drug class:
    CTLA4 inhibitor
    Related drugs:
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    A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma (NCT02339571)
    Phase 2/3
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    11/23/2015
    Primary completion :
    06/30/2033
    Completion :
    06/30/2033
    BRAF
    |
    BRAF mutation • BRAF wild-type
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar) • Leukine (sargramostim)
    Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors (NCT03866382)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    05/13/2019
    Primary completion :
    02/28/2026
    Completion :
    02/28/2026
    PD-L1 • CD4
    |
    Opdivo (nivolumab) • cisplatin • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery (NCT01950390)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    01/24/2014
    Primary completion :
    10/06/2021
    Completion :
    01/31/2026
    BRAF
    |
    BRAF mutation • BRAF wild-type
    |
    Avastin (bevacizumab) • Yervoy (ipilimumab) • Aybintio (bevacizumab biosimilar) • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Zirabev (bevacizumab-bvzr) • Krabeva (bevacizumab biosimilar) • CS1002 (ipilimumab biosimilar) • Airuituo (bevacizumab biosimilar) • Beianting (bevacizumab biosimilar) • Boyounuo (bevacizumab biosimilar) • GB222 (bevacizumab biosimilar) • Hanbeitai (bevacizumab biosimilar) • Vasforda (bevacizumab biosimilar)
    Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NRG-GY003) (NCT02498600)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    06/29/2015
    Primary completion :
    09/05/2018
    Completion :
    12/31/2025
    PD-L1
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar)
    Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia (NCT02890329)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/21/2025
    Initiation :
    09/05/2017
    Primary completion :
    10/24/2022
    Completion :
    08/19/2025
    CD4
    |
    High ALC
    |
    Yervoy (ipilimumab) • azacitidine • decitabine • CS1002 (ipilimumab biosimilar)
    Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors (NCT02496208)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/13/2025
    Initiation :
    07/22/2015
    Primary completion :
    09/30/2026
    Completion :
    09/30/2026
    PD-L1
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma (NRG-BN007) (NCT04396860)
    Phase 2/3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/10/2025
    Initiation :
    09/01/2020
    Primary completion :
    04/13/2023
    Completion :
    03/11/2025
    PD-L1 • TMB • IDH1 • MGMT
    |
    PD-L1 expression • MGMT promoter methylation • IDH1 R132
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • temozolomide • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Nivolumab and Ipilimumab in Treating Patients With Rare Tumors (SWOG S1609) (NCT02834013)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    01/30/2017
    Primary completion :
    05/01/2026
    Completion :
    05/01/2026
    CD4
    |
    PD-L1 overexpression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar) • MK-1088
    Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (E4412) (NCT01896999)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    03/07/2014
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    PD-1 • CD4 • LGALS1 • ICOS
    |
    TNFRSF8 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Adcetris (brentuximab vedotin) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (NCT04317105)
    Phase 1/2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    07/17/2020
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    PD-L1 • PIK3CA • PTEN
    |
    PIK3CA mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Aliqopa (copanlisib) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer (EA2201) (NCT04751370)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    02/08/2022
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    MSI
    |
    MSI-H/dMMR
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study (NCT03793166)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/06/2025
    Initiation :
    06/07/2019
    Primary completion :
    09/15/2025
    Completion :
    09/15/2025
    PD-L1
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia (NCI-2016-01300) (NCT02879695)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    10/25/2017
    Primary completion :
    05/22/2023
    Completion :
    07/18/2025
    CD19 • CD34 • MME
    |
    CD19 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Blincyto (blinatumomab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Ipilimumab, Ibrutinib, and Nivolumab for the Treatment of Chronic Lymphocytic Leukemia and Richter Transformation (NCT04781855)
    Phase 1
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    07/14/2022
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    BCL2
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Imbruvica (ibrutinib) • CS1002 (ipilimumab biosimilar)
    Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma (SWOG S1616) (NCT03033576)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    06/14/2024
    Initiation :
    10/23/2017
    Primary completion :
    09/19/2023
    Completion :
    12/12/2024
    CD4
    |
    CD8 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer (NCT02314169)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    06/14/2024
    Initiation :
    05/13/2015
    Primary completion :
    02/15/2025
    Completion :
    02/15/2025
    CD4
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery (SWOG S1404) (NCT02506153)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/22/2024
    Initiation :
    11/10/2015
    Primary completion :
    09/15/2023
    Completion :
    01/23/2025
    CD4
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • Intron A (interferon α-2b) • Pembroria (pembrolizumab biosimilar)
    Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer (NCI10208) (NCT03816358)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/16/2024
    Initiation :
    12/09/2019
    Primary completion :
    01/31/2025
    Completion :
    01/31/2025
    MSLN
    |
    MSLN expression • MSLN positive
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • gemcitabine • anetumab ravtansine (BAY 94-9343) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar) • liposomal gemcitabine (FF-10832)
    Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer (LONESTAR) (NCT03391869)
    Phase 3
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    05/03/2024
    Initiation :
    12/29/2017
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    EGFR • ALK • ROS1
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar)
    Low Dose Ipilimumab With Pembrolizumab in Treating Patients With Melanoma That Has Spread to the Brain (NCT03873818)
    Phase 2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    04/11/2024
    Initiation :
    02/21/2019
    Primary completion :
    08/31/2024
    Completion :
    08/31/2024
    PD-L1
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar)
    Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma (NCT02428192)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    04/02/2024
    Initiation :
    04/22/2015
    Primary completion :
    09/20/2018
    Completion :
    03/05/2025
    PD-1
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar)
    Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (NCT02408861)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    04/01/2024
    Initiation :
    10/21/2015
    Primary completion :
    07/01/2024
    Completion :
    07/01/2024
    CD8 • IFNG • CD4
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers (NCT03816332)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    03/25/2024
    Initiation :
    11/08/2019
    Primary completion :
    10/11/2022
    Completion :
    09/22/2024
    BRAF • MSI
    |
    BRAF mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • prednisone • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer (ETCTN-9844) (NCT02453620)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    03/20/2024
    Initiation :
    02/12/2016
    Primary completion :
    04/22/2021
    Completion :
    08/30/2024
    HER-2 • CD86
    |
    HR positive • HER-2 negative
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Jingzhuda (entinostat) • CS1002 (ipilimumab biosimilar) • ABP 206 (nivolumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery (NCT02500797)
    Phase 2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    10/17/2023
    Initiation :
    08/13/2015
    Primary completion :
    04/01/2019
    Completion :
    04/01/2023
    PD-L1 • CTLA4
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar)
    Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung Cancer (NCT03468985)
    Phase 2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    10/17/2023
    Initiation :
    05/07/2018
    Primary completion :
    05/09/2022
    Completion :
    12/21/2022
    EGFR • PD-L1 • ALK • RET • ROS1
    |
    EGFR L858R • EGFR exon 19 deletion • MET amplification • ALK rearrangement • MET exon 14 mutation • EGFR L861Q • EGFR G719X • RET rearrangement • EGFR negative
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • CS1002 (ipilimumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas (NCT02304458)
    Phase 1/2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    10/17/2023
    Initiation :
    03/30/2015
    Primary completion :
    09/30/2021
    Completion :
    03/31/2023
    PD-L1 • BRAF
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • CMAB 819 (nivolumab biosimilar)
    Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer (NCT01693783)
    Phase 2
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    11/08/2022
    Initiation :
    12/03/2012
    Primary completion :
    03/18/2021
    Completion :
    11/24/2021
    CRP
    |
    Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar)
    Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study (NCT04500548)
    Phase 1
    National Cancer Institute (NCI)
    Withdrawn
    Last update posted :
    09/12/2022
    Initiation :
    01/28/2021
    Primary completion :
    06/21/2022
    Completion :
    06/21/2022
    TMB • MSI • POLE • MLH1 • MSH6 • MSH2 • POLD1 • MSH3
    |
    MSI-H/dMMR • MSH2 mutation • POLD1 mutation • PMS2 mutation • EPCAM expression • POLE mutation + POLD1 mutation • MSH6 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CS1002 (ipilimumab biosimilar) • CMAB 819 (nivolumab biosimilar)