#1 Clinical Trials Search in Europe

Antihistamines For Systemic Use

This article discusses the use of antihistamines for systemic use in clinical trials for advanced urothelial carcinoma (bladder cancer). The trials aim to evaluate the safety, efficacy, and potential benefits of combining antihistamines with other cancer treatments. Understanding these trials can provide valuable insights into new treatment options for patients with this challenging condition.

Table of Contents

What are Antihistamines for Systemic Use?

Antihistamines for systemic use are a class of medications that work throughout the body to counteract the effects of histamine, a substance produced by the immune system during allergic reactions. These medications are designed to be taken orally and affect the entire body, as opposed to topical antihistamines that are applied to a specific area.[1]

Medical Conditions Treated

While antihistamines are commonly used for allergic conditions, the clinical trial data provided focuses on their potential use in cancer treatment, specifically for advanced urothelial carcinoma. Urothelial carcinoma is a type of bladder cancer that affects the lining of the urinary system, including the bladder, renal pelvis, ureter, and urethra.[1]

Current Clinical Trial

A Phase 1/2 clinical trial is currently being conducted to evaluate the safety and effectiveness of antihistamines for systemic use (referred to as MK-2870 in the trial) in combination with other cancer treatments for advanced urothelial carcinoma. The study, named KEYMAKER-U04, is investigating the following:[1]

  • The safety and tolerability of MK-2870 in combination with enfortumab vedotin (EV)
  • The safety and tolerability of MK-2870 in combination with pembrolizumab and EV
  • The overall response rate (ORR) of the combination treatments

The trial is divided into two parts:

  1. Part 1 focuses on patients who have previously received treatment for advanced urothelial carcinoma
  2. Part 2 involves patients who have not received prior systemic therapy for advanced urothelial carcinoma

Administration and Usage

In this clinical trial, antihistamines for systemic use (MK-2870) are administered orally. The exact dosing regimen and schedule will be determined as part of the study objectives.[1]

Eligibility for the Clinical Trial

To participate in this clinical trial, patients must meet specific criteria. Some key eligibility factors include:[1]

  • Age 18 years or older
  • Histologically documented advanced urothelial carcinoma
  • Measurable disease according to RECIST 1.1 criteria
  • ECOG performance status of 0 to 1 (indicating good overall health and ability to perform daily activities)

There are also several exclusion criteria, such as:

  • Prior treatment with specific cancer therapies (e.g., FGFR inhibitors, Trop-2-targeted ADCs)
  • Active autoimmune diseases
  • Certain concurrent medical conditions

Safety Considerations

As with any clinical trial, safety is a primary concern. The study will closely monitor for adverse events (AEs) and discontinuations due to AEs. Patients with a history of severe hypersensitivity to the study drugs or their components are not eligible to participate.[1]

It’s important to note that while antihistamines are generally well-tolerated, their use in cancer treatment is still being investigated. Patients considering participation in this trial should discuss potential risks and benefits with their healthcare provider.

Aspect Details
Study Type Phase 1/2 Randomized, Umbrella Study
Main Objective Evaluate safety, tolerability, and efficacy of antihistamines combined with other cancer therapies
Target Condition Advanced Urothelial Carcinoma
Key Treatments Antihistamines, MK-2870, Enfortumab Vedotin, Pembrolizumab
Primary Endpoints Adverse Events, Discontinuation rates, Objective Response Rate
Secondary Endpoints Duration of Response, Pharmacokinetics, Immunogenicity
Eligibility Adults with advanced urothelial carcinoma, specific treatment history requirements
Exclusion Criteria Certain prior treatments, active infections, severe hypersensitivities, specific medical conditions

FAQ

  • What is urothelial carcinoma? Urothelial carcinoma is a type of cancer that affects the lining of the urinary system, including the bladder, renal pelvis, ureter, and urethra. It is the most common type of bladder cancer.
  • Why are antihistamines being studied in these clinical trials? Antihistamines are being studied as part of combination therapies to potentially enhance the effectiveness of other cancer treatments and improve outcomes for patients with advanced urothelial carcinoma.
  • What other treatments are being combined with antihistamines in these trials? The trials are exploring combinations of antihistamines with other drugs such as MK-2870, enfortumab vedotin (EV), and pembrolizumab, which are targeted therapies and immunotherapies used in cancer treatment.
  • Who is eligible to participate in these clinical trials? Eligibility criteria include having advanced urothelial carcinoma, being 18 years or older, having measurable disease, and meeting specific health requirements. Some trials may have additional criteria based on previous treatments received.
  • What are the main objectives of these clinical trials? The main objectives include evaluating the safety and tolerability of the drug combinations, assessing their effectiveness in treating advanced urothelial carcinoma, and studying how the drugs interact in the body.

Ongoing Clinical Trials on Antihistamines For Systemic Use

  • Study on the Safety and Effectiveness of MK-2870, Enfortumab Vedotin, and Pembrolizumab for Patients with Advanced Bladder Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Denmark France Italy The Netherlands Spain

Glossary

  • Urothelial Carcinoma: A type of cancer that starts in the urothelial cells lining the urinary system, including the bladder, ureters, and renal pelvis.
  • Advanced Urothelial Carcinoma: Urothelial cancer that has spread beyond the lining of the bladder or urinary system to nearby tissues or lymph nodes, or to distant parts of the body.
  • Antihistamines: Medications typically used to treat allergies, but in this context, they are being studied as part of cancer treatment combinations.
  • Enfortumab Vedotin (EV): A type of targeted therapy used to treat certain types of urothelial cancer.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-mk-2870-enfortumab-vedotin-and-pembrolizumab-for-patients-with-advanced-bladder-cancer/