Clinical Trials Using Spartalizumab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Spartalizumab. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-24 of 24
  • A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

    The purpose of this study is to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.
    Location: 9 locations

  • A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands

    This primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies for whom no effective standard treatment is available.
    Location: 8 locations

  • Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

    The purpose of this first-in-human study of MBG453 is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453 administered i.v. as a single agent or in combination with PDR001 in adult patients with advanced solid tumors
    Location: 7 locations

  • Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

    The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
    Location: 7 locations

  • A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

    The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.
    Location: 5 locations

  • A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

    To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma
    Location: 4 locations

  • A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

    The purpose of this study is to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.
    Location: 4 locations

  • Dabrafenib, Trametinib, and Spartalizumab in Treating Patients with BRAFV600E Mutant Metastatic Colorectal Cancer

    This phase II trial studies the side effects and how well dabrafenib, trametinib, and spartalizumab work in treating patients with BRAFV600E mutant colorectal cancer that has spread to other places in the body. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as spartalizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving dabrafenib, trametinib, and spartalizumab may work better in treating patients with BRAFV600E mutant colorectal cancer.
    Location: 3 locations

  • Ribociclib and Spartalizumab with or without Fulvestrant in Treating Patients with Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer or Metastatic Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase I trial studies the side effects and best dose of ribociclib when given together with spartalizumab with or without fulvestrant in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread to other places in the body (metastatic), or ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body (metastatic). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as spartalizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs, such as fulvestrant, may lessen the amount of estrogen made by the body. Giving ribociclib and spartalizumab with or without fulvestrant may work better in treating patients with breast, ovarian, fallopian tube, or primary peritoneal cancer.
    Location: 3 locations

  • Study of the Safety and Efficacy of MIW815 With PDR001 to Patients With Advanced / Metastatic Solid Tumors or Lymphomas

    The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.
    Location: 3 locations

  • Study of PDR001 and / or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

    To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and / or MBG453 in combination with decitabine in AML and high risk MDS patients, and to identify recommended doses for future studies.
    Location: 3 locations

  • Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations

    A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway Alterations.
    Location: 3 locations

  • A Phase I / Ib Study of NZV930 Alone and in Combination With PDR001 and / or NIR178 in Patients With Advanced Malignancies.

    The purpose of this study is to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and / or NIR178, in patients with advanced cancers
    Location: 2 locations

  • Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

    The purpose of this trial is to explore the clinical utility of two investigational agents in patients with advanced cancer. This is a multi-center, open-label Phase I / Ib study. The study consists of four dose escalation parts and two dose expansion parts testing LHC165 as a single agent or LHC165 in combination with PDR001. The dose escalation parts will estimate the Maximum Tolerated Dose (MTD) and / or Recommended Dose for Expansion (RDE) and test two different dosing schedules for LHC165. The dose expansion parts of the study will use the MTD / RDE for each the LHC165 single agent and in combination with PDR001, determined in the respective dose escalation parts to assess the activity, safety and tolerability of LHC165 as a single agent or LHC165 in combination with PDR001 in patients with specific types of solid tumors. Approximately 206 adult patients with advanced solid tumors will be enrolled.
    Location: 2 locations

  • Phase I / II Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors

    The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent or in combination with PDR001, administered intravenously (i.v.) in adult patients with advanced solid tumors. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. Once MTD / RP2D is declared, patients will be enrolled in the phase II part in the selected indications (glioblastoma, pancreatic cancer and triple negative breast cancer) to further assess the preliminary anti-tumor activity of BLZ945 in combination with PDR001. Should signs of anti-tumor activity be seen in the phase I dose escalation with BLZ945 as single agent, a phase II part will be opened in order to further explore BLZ945 single agent efficacy at the recommended dose.
    Location: 3 locations

  • Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.

    This is a phase I / Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1 / PD-L1 therapy, or subjects with NPC. After the determination of the MTD / RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK / PD, and anti-tumor activity of each regimen at the MTD / RD.
    Location: Dana-Farber Cancer Institute, Boston, Massachusetts

  • Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

    This is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in adult patients with advanced or metastatic TNBC. During the dose-escalation part of each treatment arm, patients will be treated with fixed doses of spartalizumab + LAG525 in combination with partner investigational drugs to be escalated until the MTD is reached or a lower RDE is established: NIR178, capmatinib, MCS110, or canakinumab. It is anticipated that other partner study drugs may be added in the future by protocol amendment. After the determination of the MTD / RDE for a particular treatment arm, dose expansion may begin in that arm in order to further assess safety, tolerability, PK / PD, and anti-tumor activity of each combination at the MTD / RDE. Dose expansion arms may initiate only after consideration by the Investigators and Novartis of all available toxicity information, the assessment of risk to future patients from the BLRM, and the available PK, preliminary efficacy, and PD information. There is no requirement for dose-escalation treatment arms reaching an MTD / RDE to proceed to dose expansion.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

    This is a clinical research study and the purpose of the study is to learn whether the combination of the drugs capmatinib plus spartalizumab helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients with NSCLC. Capmatinib is an oral drug that is called a "targeted" medicine: this means it targets particular processes, which may not be working properly in the cancer cells in your body (called dysregulation) and which may be causing your disease. Spartalizumab is an antibody (a kind of protein that binds to a specific "target" protein). By blocking its "target" protein, called PD-1, spartalizumab may increase the activity of a certain type of cells in your immune system, which may reduce the growth of your tumor. Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung cancer. This standard, anti-cancer medicine is a cytotoxic chemotherapy that is being compared with capmatinib and spartalizumab. The reason for this study is to find out which of these two treatments (combination of capmatinib plus spartalizumab OR docetaxel alone) helps to control lung cancer better.
    Location: Moffitt Cancer Center, Tampa, Florida

  • A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer

    The purpose of this study is to assess the efficacy, safety, and PK characteristics of the following three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. A thorough biomarker strategy to address key aspects of tumor immunogenicity will be implemented in the study. LAG525 and spartalizumab are two immuno-agents targeting different immune checkpoints, and have been tested as single agents and in combination. To further enhance the efficacy of checkpoint inhibition, carboplatin will be given with LAG525 or with LAG525 and spartalizumab, based on the observation that the addition of chemotherapy can change the tumor microenvironment to be more favorable to immune response.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Phase I / Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

    To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.
    Location: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • Phase Ib / II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

    The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Phase Ib / II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC

    The purpose of this study of INC280 and PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent or in combination with INC280 administered orally in adult patients with advanced hepatocellular carcinoma (HCC).
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

    The purpose of this study is to determine the safety, tolerability, feasibility and preliminary efficacy of the administration of PBF-509 (Adenosine A2a receptor antagonist) as single agent or in combination with PDR001 (programmed cell death 1 receptor antibody (PD-1 Ab)) to NSCLC patients.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma

    The purpose of this study is to assess the safety, tolerability, and identify the recommended doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients with relapsed and / or refractory multiple myeloma.
    Location: See Clinical Trials.gov