^
    11h
    Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma (clinicaltrials.gov)
    P2, N=28, Recruiting, Zhejiang Cancer Hospital
    New P2 trial • Metastases
    |
    Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    11h
    Advances in Immunotherapy for Malignant Pleural Mesothelioma: From Emerging Strategies to Translational Insights. (PubMed, Open Respir Arch)
    Innovative combination regimens, exemplified by the concurrent administration of nivolumab and ipilimumab, have demonstrated marked improvement in survival and patient's benefits. This review accentuates the transformative capacity of immunotherapy in revolutionizing the therapeutic outlook for MPM, thereby potentially translating into augmented survival rates and offering glimpses of new approaches on the horizon. Despite the persisting challenges, the synergistic crossroads of interdisciplinary research and collaborative clinical endeavors portend a hopeful landscape for MPM treatment.
    Review • Journal • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NF1 (Neurofibromin 1) • PD-1 (Programmed cell death 1) • BAP1 (BRCA1 Associated Protein 1) • NF2 (Neurofibromin 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BAP1 mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    11h
    NCI-2016-00661: Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=80, Active, not recruiting, M.D. Anderson Cancer Center | N=45 --> 80
    Enrollment change
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    14h
    AK104-206: A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=59, Completed, Akeso | Recruiting --> Completed | N=30 --> 59 | Trial primary completion date: Apr 2023 --> Nov 2023
    Trial completion • Enrollment change • Trial primary completion date • Combination therapy • Metastases
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    15h
    A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2, N=50, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Dec 2022 --> Feb 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • Kaitanni (cadonilimab)
    16h
    A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=198, Recruiting, Akeso | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Feb 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Kaitanni (cadonilimab) • pulocimab (AK109)
    16h
    A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=32, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Aug 2023
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    18h
    A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=46, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type
    |
    carboplatin • paclitaxel • pemetrexed • Kaitanni (cadonilimab)
    1d
    ESR-22-21719: Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=28, Recruiting, Georgetown University | Initiation date: Mar 2024 --> Jun 2024
    Trial initiation date • Combination therapy
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
    2d
    Predictive factors of nivolumab plus ipilimumab treatment efficacy in metastatic renal cell carcinoma patients. (PubMed, Jpn J Clin Oncol)
    Patients without cytoreductive nephrectomy and with bone metastasis, liver metastasis, high C-reactive protein levels and paraneoplastic symptoms were significantly correlated with shorter progression-free survival. The presence of paraneoplastic symptoms was an independent predictor of progression-free survival. Improvement in paraneoplastic symptoms may reflect the treatment efficacy of nivolumab plus ipilimumab.
    Journal • Metastases
    |
    CRP (C-reactive protein)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    3d
    CHINOREC: Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer (clinicaltrials.gov)
    P2, N=80, Completed, Johannes Laengle, MD, PhD | Recruiting --> Completed | Trial completion date: Dec 2024 --> Mar 2024 | Trial primary completion date: Jun 2024 --> Mar 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • capecitabine
    3d
    A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, University Health Network, Toronto
    New P1 trial • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    7d
    Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer (clinicaltrials.gov)
    P2, N=35, Recruiting, Zhongnan Hospital | Trial completion date: Mar 2025 --> Feb 2027 | Trial primary completion date: Oct 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    Focus V (anlotinib) • Kaitanni (cadonilimab)
    7d
    Durvalumab(MEDI4736)/Tremelimumab in Combination With Gemcitabine/Cisplatin in Chemotherapy-naïve Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Seoul National University Hospital | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Combination therapy
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
    8d
    SAINT:Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P1/2, N=45, Recruiting, Sarcoma Oncology Research Center, LLC | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Yondelis (trabectedin)
    8d
    SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=36, Not yet recruiting, West China Hospital
    New P1/2 trial • Metastases
    |
    Avastin (bevacizumab) • SHR-8068 • adebrelimab (SHR-1316)
    8d
    An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers (clinicaltrials.gov)
    P1/2, N=494, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Stivarga (regorafenib) • BMS-986288
    8d
    Autopsy case of meningoencephalitis induced by nivolumab and ipilimumab in a patient being treated for non-small cell lung cancer. (PubMed, Intern Med)
    A 75-year-old woman with stage IVB (cT2bN3M1b) lung adenocarcinoma was administered nivolumab, ipilimumab, carboplatin, and paclitaxel. An autopsy showed encephalitis and CD8+ lymphocyte infiltration around the blood vessels. Thus, immune-related adverse events should be suspected and treatment should be initiated for patients presenting with an impaired consciousness when concurrently being treated with nivolumab and ipilimumab.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel
    9d
    C-IT Neo: CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma (clinicaltrials.gov)
    P2, N=28, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Surgery • Pre-surgery
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    9d
    Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment (clinicaltrials.gov)
    P2, N=27, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Feb 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
    Enrollment open • Trial initiation date • Trial primary completion date • Metastases
    |
    Focus V (anlotinib) • Kaitanni (cadonilimab)
    9d
    Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC (clinicaltrials.gov)
    P3, N=48, Recruiting, Maximilian Diehn | Trial completion date: Mar 2026 --> Apr 2028 | Trial primary completion date: Mar 2024 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • Imjudo (tremelimumab) • pemetrexed
    9d
    Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov)
    P1/2, N=263, Recruiting, Salubris Biotherapeutics Inc | N=149 --> 263
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • SAL008
    9d
    A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (clinicaltrials.gov)
    P3, N=469, Not yet recruiting, Akeso
    New P3 trial • Combination therapy • Metastases
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    9d
    A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=53, Not yet recruiting, Wuhan Union Hospital, China
    New P2 trial • Metastases
    |
    doxorubicin hydrochloride • Kaitanni (cadonilimab)
    9d
    Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=27, Recruiting, Wuhan Union Hospital, China
    New P2 trial • Metastases
    |
    Kaitanni (cadonilimab)
    9d
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=413, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)
    10d
    PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Presage Biosciences
    New P1 trial
    |
    Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
    10d
    INSPIRE: Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Radboud University Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Feb 2026 | Trial primary completion date: Jan 2025 --> Aug 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset) • CDK12 (Cyclin dependent kinase 12)
    |
    TMB-H
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    10d
    Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study (clinicaltrials.gov)
    P=N/A, N=300, Recruiting, AstraZeneca | Trial completion date: Oct 2024 --> Dec 2026 | Trial primary completion date: Oct 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab)
    10d
    Binimetinib in combination with nivolumab or nivolumab and ipilimumab in patients with previously treated microsatellite-stable metastatic colorectal cancer with RAS mutations in an open-label phase 1b/2 study. (PubMed, BMC Cancer)
    The RP2D binimetinib regimen had a safety profile similar to previous binimetinib studies or nivolumab and ipilimumab combination studies. There was a lack of clinical benefit with either drug combination. Therefore, these data do not support further development of binimetinib in combination with nivolumab or nivolumab and ipilimumab in RAS-mutated MSS mCRC.
    P1/2 data • Clinical Trial,Phase II • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    MAP2K2 (Mitogen-activated protein kinase kinase 2) • RAS (Rat Sarcoma Virus)
    |
    RAS mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Mektovi (binimetinib)
    11d
    DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, University of Alabama at Birmingham
    New P2 trial • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel • pemetrexed
    11d
    NeoRelapse: Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, University of Utah
    New P2 trial
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    11d
    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)
    11d
    Cadonilimab in Combination With Ramucirumab for the Treatment of Advanced Hepatocellular Carcinoma That Has Failed at Systemic Therapy (clinicaltrials.gov)
    P1, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Phase classification: P2 --> P1 | Initiation date: Jun 2023 --> Jun 2024
    Phase classification • Trial initiation date • Combination therapy • Metastases
    |
    Cyramza (ramucirumab) • Kaitanni (cadonilimab)
    12d
    Good response of cadonilimab (PD-1/CTLA-4 Bi-specific antibody) to patients with advanced lung adenocarcinoma after immunotherapy resistance: A case report. (PubMed, Asian J Surg)
    No abstract available
    Journal • Metastases
    |
    PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Kaitanni (cadonilimab)
    14d
    A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients with Unresectable Stage III and IV Melanoma (ACTRN12617000772347)
    P1/2, N=72, Completed, Peter MacCallum Cancer Centre | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Prolia (denosumab)
    14d
    SCALE: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Hui-Chuan Sun
    New P2 trial
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    14d
    NCI-2018-03329: Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer (clinicaltrials.gov)
    P1, N=7, Completed, Claire Verschraegen | Active, not recruiting --> Completed
    Trial completion
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab)
    14d
    Real-world evidence of efficacy of pembrolizumab plus chemotherapy and nivolumab plus ipilimumab plus chemotherapy as initial treatment for advanced non-small cell lung cancer. (PubMed, Thorac Cancer)
    In real-world practice, CP demonstrated superior PFS compared with CNI. These findings can inform treatment selection in advanced NSCLC.
    Journal • HEOR • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
    15d
    CheckRad-CD8: Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC (clinicaltrials.gov)
    P2, N=120, Completed, University of Erlangen-Nürnberg Medical School | Active, not recruiting --> Completed
    Trial completion • Checkpoint inhibition • Checkpoint block • Metastases
    |
    CD8 (cluster of differentiation 8)
    |
    Imfinzi (durvalumab) • Imjudo (tremelimumab)
    16d
    CheckMate901: Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P3, N=1290, Active, not recruiting, Bristol-Myers Squibb | Trial primary completion date: Apr 2024 --> Oct 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • gemcitabine
    16d
    A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=122, Recruiting, HC Biopharma Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)