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 1-17 of 17
  • 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: 15 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: 17 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, fallopian tube or peritoneum.
    Location: 12 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 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: 6 locations

  • 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: 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 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

  • 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 everolimus and letrozole with or without ribociclib 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 such as everolimus and letrozole have been shown to be effective at stopping tumor growth either by killing the cells, by stopping them from dividing, or by 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

  • Aromatase Inhibitor Therapy with or without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer with an ERS1 Activating Mutation, the INTERACT Study

    This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and / or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has spread to other places in the body (metastatic) and has an ERS1 activating mutation. Letrozole, anastrozole, ribociclib, palbociclib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known if giving letrozole, anastrozole, or fulvestrant with ribociclib, palbociclib, and / or abemaciclib will work better in treating patients with breast cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • 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

  • 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 (recurrent) or do not respond to treatment (refractory). 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: Saint Jude Children's Research Hospital, Memphis, Tennessee

  • 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

  • Ribociclib and Belinostat in Patients with Metastatic Triple Negative Breast Cancer or Recurrent Platinum-Resistant Ovarian Cancer, Charge Study

    This phase I / Ib trial investigates the side effects and best dose of ribociclib and belinostat and how well they work treating patients with triple negative breast cancer that has spread to other parts of the body (metastatic) or ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (platinum-resistant) and has come back (recurrent). Ribociclib and belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ribociclib and belinostat in combination may work better to treat patients with breast cancer and ovarian cancer compared to either drug alone.
    Location: Huntsman Cancer Institute / University of Utah, Salt Lake City, Utah

  • 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 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