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 1-21 of 21
  • 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

  • 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: 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

  • Phase I-Ib / II Study 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 or decitabine in adult patients with advanced solid tumors
    Location: 5 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

  • 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: 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

  • KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

    The purpose of this trial is to explore the clinical utility of several therapies in patients with advanced cancer. This is a multi-center, open-label Phase I / Ib study. The study consists of a dose escalation part, a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178. The dose escalation parts will estimate the MTD and / or RD and test different dosing schedules. The dose expansion parts of the study will use the MTD / RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer. Approximately 135 adult patients with advanced solid tumors will be enrolled.
    Location: 3 locations

  • 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: 2 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

  • A 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, glioblastoma patients will be enrolled in the phase II part to further assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001.
    Location: 2 locations

  • Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB / C / D Melanoma

    This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB / C / D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. Patients who achieve a pathologic complete response after 8 weeks of neoadjuvant dabrafenib and trametinib will receive adjuvant dabrafenib and trametinib. 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 help to control melanoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

    The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • Neoadjuvant Spartalizumab and Canakinumab for the Treatment of Patients with Localized Kidney Cancer, SPARC-1 Trial

    This pilot phase Ib trial studies the side effects and how well spartalizumab and canakinumab work in treating patients with kidney cancer that that has not spread to other parts of the body (localized). 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. Immunotherapy with canakinumab may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving spartalizumab and canakinumab before surgery may work better than giving no treatment before surgery in treating kidney cancer.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

    This study is a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and / or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.
    Location: Massachusetts General Hospital Cancer Center, Boston, Massachusetts

  • MBG453, Spartalizumab, and Stereotactic Radiosurgery for the Treatment of Recurrent Glioblastoma

    This phase I trial investigates the side effects of MBG453 when given in combination with spartalizumab and stereotactic radiosurgery in treating patients with glioblastoma (brain cancer) that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as MBG453 and spartalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery uses radiation to treat tumors without needing to cut or use stitches. The purpose of this trial is to find out if two study drugs, MBG453 and spartalizumab, are safe to give with stereotactic radiosurgery in patients with glioblastoma.
    Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland

  • 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 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: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • 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

  • A Study of Select Drug Combinations in Adult Patients With Advanced / Metastatic BRAF V600 Colorectal Cancer

    A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California