Clinical Trials Using Ribociclib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Ribociclib. 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 1-22 of 22
  • Fulvestrant or Exemestane with or without Ribociclib in Patients with Recurrent, Unresectable, or Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

    This randomized, phase II trial studies how well fulvestrant or exemestane with or without ribociclib works in treating patients with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer that has progressed after treatment with an aromatase inhibitor or cyclin-dependent kinase 4 / 6 inhibitor, cannot be removed by surgery, or has spread to other parts of the body. Hormone therapy using fulvestrant or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fulvestrant or exemestane with ribociclib may be an effective treatment for patients with breast cancer.
    Location: 11 locations

  • Ribociclib and Everolimus in Treating Children with Recurrent or Refractory Malignant Brain Tumors

    This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and everolimus may work better at treating malignant brain tumors.
    Location: 6 locations

  • Phase I / Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

    To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.
    Location: 6 locations

  • Ribociclib, Docetaxel. and Prednisone in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

    This phase Ib / II trial studies the side effects and best dose of ribociclib when given together with docetaxel and prednisone and to see how well they work in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib together with docetaxel and carboplatin may work better in treating metastatic castration-resistant prostate cancer.
    Location: 5 locations

  • Ribociclib in Treating Patients with Estrogen Receptor Positive Breast Cancer

    This randomized phase II trial studies how well ribociclib works in treating patients with estrogen receptor positive breast cancer. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 4 locations

  • Enzalutamide with or without Ribociclib in Treating Patients with Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

    This partially randomized phase Ib / II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.
    Location: 4 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, or ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body. 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

  • Ribociclib and Gemcitabine Hydrochloride in Treating Patients with Advanced or Metastatic Solid Tumors

    This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and gemcitabine hydrochloride may work better in treating patients with solid tumors.
    Location: 3 locations

  • Ribociclib and Everolimus in Treating Patients with Advanced Well Differentiated Neuroendocrine Tumors of Foregut Origin

    This phase II trial studies how well ribociclib and everolimus work in treating patients with well differentiated neuroendocrine tumors of foregut origin that have spread to other parts of the body and usually cannot be cured or controlled with treatment. Ribociclib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 6 locations

  • A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

    To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.
    Location: 4 locations

  • Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

    Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.
    Location: 4 locations

  • Ribociclib with Trastuzumab or Trastuzumab Emtansine in Treating Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

    This phase Ib / II trial studies the best dose of ribociclib with trastuzumab or trastuzumab emtansine and to see how well they work in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body and is human epidermal growth factor receptor 2 (HER2)-positive. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with trastuzumab may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2-positive tumor cells in a targeted way and delivers emtansine to kill them. Giving ribociclib with trastuzumab emtansine or trastuzumab may work better in treating patients with breast cancer.
    Location: 3 locations

  • Ribociclib and Chemoembolization in Treating Patients with Advanced Liver Cancer

    This phase Ib / II trial studies the best dose and side effects of ribociclib when given together with chemoembolization in treating patients with liver cancer that has gotten worse. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near tumors and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Giving ribociclib and chemoembolization may work better in treating patients with liver cancer.
    Location: 3 locations

  • Ribociclib and Everolimus in Treating Patients with Locally Advanced, Metastatic, or Refractory Dedifferentiated Liposarcoma or Leiomyosarcoma

    This phase II clinical trial studies how well ribociclib and everolimus work in treating patients with dedifferentiated liposarcoma or leiomyosarcoma that has spread to nearby tissue or to other places in the body or has not responded to treatment. Ribociclib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Ribociclib, Gemcitabine Hydrochloride, Trametinib, and Sonidegib in Treating Patients with Refractory or Recurrent Brain Cancers

    This phase I trial studies the best dose and side effects of ribociclib, gemcitabine hydrochloride, trametinib, and sonidegib in treating children and young adults with brain cancers that have come back or do not respond to treatment. Ribociclib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and sonidegib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib, gemcitabine hydrochloride, trametinib, and sonidegib may work better at treating brain cancers.
    Location: St. Jude Children's Research Hospital, Memphis, Tennessee

  • Ribociclib with Carboplatin and Paclitaxel in Treating Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase I trial studies the side effects and best dose of ribociclib with carboplatin and paclitaxel in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib with carboplatin and paclitaxel may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • A Phase 1B Study of Ribociclib in Combination with Doxorubicin in Advanced Soft Tissue Sarcomas

    This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and doxorubicin hydrochloride may work better in treating patients with soft tissue sarcoma.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • Ribociclib and Everolimus in Treating Patients with Metastatic Pancreatic Cancer That is Refractory to Chemotherapy

    This phase I / II trial studies the side effects and best dose of ribociclib and to see how well it works when given together with everolimus in treating patients with pancreatic cancer that has spread to other places in the body and does not respond to chemotherapy treatment. Ribociclib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: MedStar Georgetown University Hospital, Washington, District of Columbia

  • Next Generation Personalized Neuroblastoma Therapy with Ribociclib and Ceritinib, Trametinib, or HDM2 Inhibitor HDM201 in Treating Younger Patients with High-Risk Neuroblastoma

    This phase I trial studies the side effects and best dose of ribociclib when given together with ceritinib, and HDM2 inhibitor HDM201, and to also see how well ribociclib and ceritinib, trametinib, or HDM2 inhibitor HDM201 work in treating patients with high-risk neuroblastoma. Ribociclib, ceritinib, trametinib, and HDM2 inhibitor HDM201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Assigning patients to different treatment groups with ribociclib and ceritinib, trametinib, or HDM2 inhibitor HDM201 based on genetic testing may work better in treating neuroblastoma.
    Location: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

  • Ribociclib and Paclitaxel in Treating Patients with Metastatic Rb+ Breast Cancer

    This phase I trial studies the side effects and the best dose of ribociclib when given together with paclitaxel in treating patients with breast cancer expressing retinoblastoma protein positive (Rb+) and has spread to other places in the body (metastatic). Ribociclib may stop the growth of tumor cells by blocking some proteins, such as Rb+, needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib together with paclitaxel may work better in treating patients with metastatic breast cancer.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+ / HER2- Early Breast Cancer

    A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+ / HER2- Early Breast Cancer
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Ribociclib and Letrozole Treatment in Ovarian Cancer

    The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary or peritoneum.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio