Clinical Trials Using Tocilizumab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Tocilizumab. 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 1-23 of 23
  • A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

    This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL) and in participants with follicular lymphoma (FL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R / R) DLBCL and 2L+ R / R FL.
    Location: 10 locations

  • A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma

    CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part.
    Location: 9 locations

  • A Phase Ib / II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

    This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R / R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
    Location: 9 locations

  • A Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Therapy in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma Who Are Unable to Tolerate Full-Dose Chemotherapy

    This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of partial response, or in participants with previously untreated DLBCL who are unable to tolerate full-dose, first-line immunochemotherapy.
    Location: 5 locations

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer

    This is a Phase Ib / II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC. The study will be performed in two stages. During Stage 1, two cohorts will be enrolled in parallel in this study: one cohort will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort), and one cohort will consist of participants who had disease progression during or following 1L treatment with chemotherapy (e.g., paclitaxel, nab-paclitaxel, carboplatin) and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). In addition, participants in the 2L CIT-naive cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.
    Location: 3 locations

  • Trastuzumab, Pertuzumab, Tocilizumab in Treating Participants with Metastatic or Unresectable HER2 Positive Breast Cancer

    This phase I trial studies the best dose and side effects of trastuzumab, pertuzumab and tocilizumab in treating participants with HER2 positive breast cancer that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies such as trastuzumab, pertuzumab and tocilizumab, may interfere with the ability of tumor cells to grow and spread
    Location: 3 locations

  • A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

    A Phase Ib / II, open-label, multicenter, randomized, umbrella study in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status).
    Location: 2 locations

  • A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

    This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: the first-line (1L) cohort will consist of patients who have not received any systemic therapy for their disease and the second-line (2L) cohort will consist of patients who progressed during or after receiving a platinum-containing regimen and a PD-L1 / PD-1 checkpoint inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms.
    Location: 3 locations

  • Tocilizumab for the Prevention of Respiratory Failure and Death in Patients with Severe COVID-19 Infection

    This phase II trial studies the effect of tocilizumab in preventing respiratory failure and death in patients with severe COVID-19 infection. Part of the complications from the COVID-19 infection may be due to the virus causing damage to the lungs, some of this damage may be caused by an extreme inflammatory reaction produced by the immune system as it tries to fight off the virus. A protein called IL-6 (interleukin 6) plays a major role in this type of inflammation. Tocilizumab may prevent IL-6 from attaching to cells. By blocking IL-6, tocilizumab may prevent damage to the lungs and reduce the need for treatment with a mechanical ventilator. If a patient is already receiving mechanical ventilation to assist with breathing, tocilizumab may improve the patient’s condition enough to allow this treatment to be stopped.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • A Study of Rituximab or Tocilizumab for Cancer Patients that Develop Immunotherapy-Related Side Effects Requiring Prolonged Steroid Use

    This phase II trial investigates how well either rituximab or tocilizumab work in treating cancer patients who have developed side effects while on immunotherapy that require prolonged use of steroids. Immune-related side effects are caused by activation of the immune system from treatment with immunotherapy. Steroids can cause many side effects with prolonged use including problems with sleep, weight gain, diabetes, muscle loss, high blood pressure, high cholesterol, bone loss, and mood disturbances. Rituximab and tocilizumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Giving rituximab or tocilizumab may manage immune-related side effects and ultimately help cancer patients get off steroids.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • Itacitinib and Tocilizumab for the Treatment of Steroid Refractory Acute Graft versus Host Disease

    This phase I trial studies the side effects and best dose of itacitinib and tocilizumab in treating patients with acute graft versus host disease that does not respond to steroid therapy (steroid refractory). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tocilizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving itacitinib and tocilizumab may be beneficial in treating patients with steroid refractory acute graft versus host disease.
    Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York

  • Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Unresectable Stage IIIb-IV Melanoma

    This phase II trial studies the side effects and how well tocilizumab, ipilimumab, and nivolumab work in treating patients with stage IIIb-IV melanoma that cannot be removed by surgery (unresectable). Tocilizumab is a monoclonal antibody that works by blocking the receptor of the interleukin-6 (IL-6) protein in the body. IL-6 is a protein thought to help cancer cells grow and survive against the body’s defense mechanisms. Tocilizumab blocks the receptor of the IL-6 protein, which prevents the IL-6 protein from functioning. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tocilizumab, ipilimumab, and nivolumab may work better in treating patients with melanoma compared to ipilimumab and nivolumab alone.
    Location: 3 locations

  • Tocilizumab in Treating Children and Adolescents with Newly-Diagnosed, Recurrent, or Progressive Adamantinomatous Craniopharyngioma

    This early phase I trial studies how well tocilizumab works in treating children and adolescents with adamantinomatous craniopharyngioma that is newly diagnosed, has come back (recurrent), or is growing, spreading, or getting worse (progressive). Immunotherapy with tocilizumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread.
    Location: Children's Hospital Colorado, Aurora, Colorado

  • Atezolizumab with or without Tocilizumab in Treating Men with Localized Prostate Cancer before Radical Prostatectomy

    This phase II trial studies how well atezolizumab works alone or in combination with tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tocilizumab is an antibody (a protein similar to those produced by the body's immune system) that binds to a protein called IL-6R. High levels of IL-6 may promote tumor growth. Blocking IL-6R with tocilizumab may reset the immune system to recognize the tumor and help shrink it. We want to see how effective atezolizumab and tocilizumab are when used together for people with advanced local prostate cancer.
    Location: 2 locations

  • Atezolizumab with or without Tocilizumab or Other Immune Modulating-Agents in Treating Patients with Stage III or IV Head and Neck Squamous Cell Cancer

    This phase II trial studies how well atezolizumab works in treating patients with stage III or IV head and neck squamous cell cancer, and if adding atezolizumab to the standard-of-care treatment (surgical resection followed by radiation or chemoradiation) decreases the occurrence of cancer relapse. Atezolizumab is an antibody (a protein used by the body's immune system to identify and neutralize foreign substances such as bacteria, viruses, and tumor cells) that affects the immune system by blocking the PD-L1 pathway. The PD L1 pathway is involved in decreasing the body’s natural immune response to fight cancer. By blocking the PD-L1 pathway, atezolizumab may help your immune system stop or reverse the growth of tumors. Tocilizumab is an antibody (a protein similar to those produced by the body's immune system) that binds to a protein called IL-6R. High levels of IL-6 may promote tumor growth. Blocking IL-6R with tocilizumab may reset the immune system to recognize the tumor and help shrink it. The body’s immune system has a certain natural ability to withstand tumor growth. Tumors partially resist the immune system and atezolizumab may help your immune system to withstand the growth of tumors. Giving atezolizumab in combination with tocilizumab may have additional immune effects against tumors. The purpose of this study is to investigate the effect of atezolizumab or atezolizumab in combination with tocilizumab on infiltration of the tumor by T-cells (a type of white blood cell).
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Non-Hodgkin Lymphomas and Participants With DLBCL

    This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G / R-CHOP or R-CHOP) in participants with r / r NHL and untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts: - Part I: Dose finding in participants with r / r NHL; test use of G vs R in Cycle 1 - Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with r / r NHL and those with untreated DLBCL (>60 years of age with an age-adjusted International Prognostic Index (IPI) of 2-3). Particularly, the impact of using glofitamab plus G / R-CHOP (i.e., add-on arm) versus glofitamab plus CHOP (i.e., replacement arm) will be assessed in untreated DLBCL participants.
    Location: 2 locations

  • Tocilizumab in Improving Graft-Versus-Host Disease and Early Side Effects in Patients with Blood Cancers Undergoing Umbilical Cord Blood Transplant

    This phase II trial studies how well tocilizumab works in improving graft-versus-host disease (GVHD) and early side effects in patients with blood cancers undergoing umbilical cord blood transplant. Giving chemotherapy and total-body irradiation before an umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called GVHD). Giving tocilizumab in addition to the standard approach for GVHD prevention after the transplant may stop this from happening.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed / Refractory B-Cell Non-Hodgkin's Lymphoma

    This is a Phase I, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-to-human study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD / OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.
    Location: 2 locations

  • Autologous IC9-CAR19 T cells in Treating Patients with Recurrent or Refractory Acute Lymphoblastic Leukemia

    This phase I trial studies the side effect of autologous inducible caspase 9 chimeric antigen receptor targeting CD19 antigen (iC9-CAR19) T cells in treating patients with acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). IC9-CAR19 T cells combines antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances and by stopping them from growing. T cells are special infection fighting blood cells that can kill other cells, including cancer cells or cells that are infected.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Tocilizumab for the Treatment of CART19 Associated Cytokine Release Syndrome in Patients with CD19 Positive Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Lymphoblastic Lymphoma

    This early phase I trial studies how well tocilizumab works in treating cytokine release syndrome caused by treatment with CART19 T-cells (genetically modified white blood cells) in patients with CD19 positive B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Tocilizumab may help control cytokine release syndrome side effects in patients who are receiving treatment with CART19 T-cells for B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma
    Location: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

  • Alemtuzumab or Tocilizumab in Combination with Etoposide and Dexamethasone in Treating Patients with Hemophagocytic Lymphohistiocytosis

    This phase II trial studies how well alemtuzumab or tocilizumab in combination with etoposide and dexamethasone work in treating patients with hemophagocytic lymphohistiocytosis. Hemophagocytic lymphohistiocytosis is a disorder that causes abnormal over activity of the immune system. Immunosuppressive therapy, using drugs such as alemtuzumab, tocilizumab, etoposide, and dexamethasone, may decrease the body’s immune system activity and prevent the immune system from causing damage to organs.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Modified Immune Cells (CD19 / CD20 CAR-T Cells) in Treating Patients with Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia

    This phase I trial studies the side effects and best dose of CD19 / CD20 chimeric antigen receptor (CAR) T-cells when given together with chemotherapy, and to see how effective they are in treating patients with non-Hodgkin's B-cell lymphoma or chronic lymphocytic leukemia that has come back (recurrent) or has not responded to treatment (refractory). In CAR-T cell therapy, a patient's white blood cells (T cells) are changed in the laboratory to produce an engineered receptor that allows the T cell to recognize and respond to CD19 and CD20 proteins. CD19 and CD20 are commonly found on non-Hodgkin’s B-cell lymphoma and chronic lymphocytic leukemia cells. Chemotherapy drugs such as fludarabine phosphate and cyclophosphamide can control cancer cells by killing them, by preventing their growth, or by stopping them from spreading. Combining CD19 / CD20 CAR-T cells and chemotherapy may help treat patients with recurrent or refractory B-cell lymphoma or chronic lymphocytic leukemia.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients with SARS-CoV-2 Infection

    This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substances (cytokines) made by cells of the immune system as a response to SARS-CoV-2 infection. Tocilizumab may help lower the body’s immune response and reduce inflammation. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia