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 1-25 of 25
  • 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 (recurrent), cannot be removed by surgery (unresectable), or has spread to other parts of the body (metastatic). 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: 12 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: 8 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 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: 5 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 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: 6 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

  • 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

  • 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

  • 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 in Combination with Everolimus and Dexamethasone in Treating Children and Young Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia

    This phase I trial studies the best dose and side effects of ribociclib when given with everolimus and dexamethasone, and to see how well they work in treating children and young adults with acute lymphoblastic leukemia that has come back or does not respond to treatment. Ribociclib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, 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 everolimus and dexamethasone may work as a possible treatment for relapsed or refractory acute lymphoblastic leukemia.
    Location: 3 locations

  • 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: 6 locations

  • A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)

    In this research study, we want to learn about the safety of the study drugs, ribociclib and everolimus, when given together at different doses after radiation therapy. We also want to learn about the effects, if any, these drugs have on children and young adults with brain tumors. We are asking people to be in this research study who have been diagnosed with a high grade glioma, their tumor has been screened for the Rb1 protein, and they have recently finished radiation therapy. If a patient has DIPG or a Bi-thalamic high grade glioma, they do not need to have the tumor tissue screened for the Rb1 protein, but do need to have finished radiation therapy. Tumor cells grow and divide quickly. In normal cells, there are proteins that control how fast cells grow but in cancer cells these proteins no longer work correctly making tumor cells grow quickly. Both study drugs work in different ways to slow down the growth of tumor cells. The researchers think that if the study drugs are given together soon after radiation therapy, it may help improve the effect of the radiation in stopping or slowing down tumor growth. The study drugs, ribociclib and everolimus, have been approved by the United States Food and Drug Administration (FDA). Ribociclib is approved to treat adults with breast cancer and everolimus is approved for use in adults and children who have other types of cancers. The combination of ribociclib and everolimus has not been tested in children or in people with brain tumors and is considered investigational. The goals of this study are: - Find the safest dose of ribociclib and everolimus that can be given together after radiation. - Learn the side effects (both good and bad) the study drugs have on the body and tumor. - Measure the levels of study drug in the blood over time. - Study the changes in the endocrine system that may be caused by the tumor, surgery or radiation.
    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 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: 5 locations

  • 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: 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

  • 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

  • A Phase II, Two-Arm Study of Everolimus and Letrozole, + / - Ribociclib (Lee011) in Patients with Advanced or Recurrent Endometrial Carcinoma

    This phase II trial studies how well ribociclib, everolimus, and letrozole work in treating participants with endometrial cancer that has spread to other areas of the body or 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 everolimus, and letrozole, work in different ways to sop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or b stopping them from spreading. Giving ribociclib, everolimus, and letrozole may work better than everolimus and letrozole in treating participants with endometrial cancer.
    Location: 2 locations

  • 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

  • Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

    QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib (Kisqali® Prescribing Information, Investigator Brochure). The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on / 1 week off schedule. The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on / 1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well. Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on / 1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3 weeks on / 1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and / or liver metastases (yes versus no).
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia