Clinical trials located in

Koeln

Koeln city is located in Germany. Currently, 4 clinical trials are being conducted in this city.

  • CT-EU-00121743

    Study comparing Giredestrant and Fulvestrant with CDK4/6 Inhibitors for advanced breast cancer

    This study focuses on a type of advanced breast cancer known as Estrogen Receptor-Positive (ER+), HER2-Negative breast cancer. This kind of cancer is driven by hormones and does not have high levels of the HER2 protein. The study aims to evaluate the effectiveness and safety of a new drug called Giredestrant compared to an existing drug called Fulvestrant. Both drugs will be combined with one of three medicines that inhibit proteins in cancer cells called CDK4/6 inhibitors (Palbociclib, Ribociclib, or Abemaciclib).

    In this study, participants will be randomly assigned to one of two groups. One group will receive Giredestrant and the other will receive Fulvestrant. Both groups will also receive one of the CDK4/6 inhibitors chosen by their doctor. These combinations are being tested to see which works better to stop the cancer from growing or spreading.

    The drugs involved include Giredestrant (RO7197597, RG6171, GDC-9545), Fulvestrant, Abemaciclib, Palbociclib, Ribociclib, and LHRH Agonist (for pre/perimenopausal women and men).

    The goal is to find out if Giredestrant can provide better results and fewer side effects compared to Fulvestrant when both are combined with one of the CDK4/6 inhibitors. The study may involve regular tests and assessments to monitor the cancer’s progress and the patient’s response to the treatment.

    Participants will continue to receive the study drugs as long as they are benefiting from them and not experiencing unacceptable side effects. The study involves close monitoring to ensure the safety and well-being of all participants throughout the treatment period.

    • LHRH Agonist
    • Abemaciclib
    • Giredestrant
    • Palbociclib
    • Ribociclib
    • Fulvestrant
  • Comparison of Olorofim and AmBisome® for Treating Invasive Aspergillosis in Patients Who Cannot Use Azole Therapy

    This study focuses on patients dealing with a serious fungal infection called Invasive Aspergillosis (IA). This infection is known to be particularly dangerous for people with weakened immune systems. Two drugs will be compared in this study: Olorofim (also known as F901318) and AmBisome® (liposomal amphotericin B). These drugs are used to treat patients who have a confirmed or suspected IA infection.

    AmBisome® is an established treatment, while Olorofim is a newer medication that works differently. This new drug aims to provide an alternative for patients who don’t respond well to existing therapies.

    The purpose of this study is to compare the effectiveness and safety of Olorofim with AmBisome®, followed by standard care according to medical guidelines. Patients will receive one of the treatments, and their response will be monitored over several months.

    Patients will start with either Olorofim or AmBisome® for a set period, then switch to the standard care recommended by their doctors. This approach allows researchers to understand how well each treatment works and what side effects might occur.

    Participation includes regular follow-ups and assessments to monitor the patient’s health, response to the medication, and any potential side effects. The ultimate goal is to find the best possible treatment for IA, improving outcomes for patients affected by this serious fungal infection.

    • AmBisome®
    • olorofim
  • To evaluate the effectiveness of nivolumab used alone and in combination with HBI-8000 in the treatment of unresectable or metastatic melanoma

    This is a study comparing two treatment options for patients with melanoma that cannot be surgically removed or has spread to other parts of the body. One treatment option is an investigational drug called Tucidinostat (HBI-8000) taken by mouth twice a week in combination with an approved drug called nivolumab given by intravenous infusion. Another option is a placebo taken orally twice a week, also in combination with nivolumab given by intravenous infusion.

    The primary goal of the study is to determine whether the combination of HBI-8000 and nivolumab is more effective than nivolumab alone in shrinking the tumor or preventing further tumor progression. The study will also assess the safety of the treatment combinations.

    Patients enrolled in the main study will be randomly assigned to receive either the HBI-8000 combination or a placebo combination. Treatment will continue for up to 2 years or until the cancer progresses, side effects worsen or the patient decides to withdraw from the study. The study will last up to 4 years and will include regular monitoring and follow-up visits.

    • Placebo
    • Tudicdinostat/HBI-8000
  • Evaluating Ianalumab for active Sjogren’s syndrome

    The NEPTUNUS-2 study is a significant research project aimed at exploring the effectiveness and safety of a medication called ianalumab (VAY736) for individuals suffering from active Sjogren’s Syndrome. This study is designed as a three-arm, randomized, double-blind, placebo-controlled trial, which means participants will be randomly assigned to one of three groups: two will receive ianalumab at different intervals, and one will receive a placebo, with neither the participants nor the researchers knowing which group participants are in to ensure unbiased results.

    The main goal of this study is to determine how well ianalumab can improve the symptoms of Sjogren’s Syndrome compared to a placebo. This will be measured by the change in a specific score called the EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) from the start of the study to week 48. The ESSDAI score helps doctors understand how active the disease is, with a higher score indicating more active disease. A decrease in this score over time would suggest an improvement in the condition.

    Participants in this study will receive ianalumab injections either once a month or every three months, depending on the group they are assigned to. The study emphasizes not only the potential benefits of ianalumab in treating Sjogren’s Syndrome but also its safety and tolerability, ensuring that the treatment is not only effective but also safe for patients.

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