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Cetrelimab

Cetrelimab is an investigational immunotherapy drug being studied in clinical trials for the treatment of various types of cancer. As a PD-1 inhibitor, it works by helping the immune system recognize and attack cancer cells. This article summarizes key information about ongoing clinical trials evaluating cetrelimab alone and in combination with other therapies for conditions like prostate cancer, bladder cancer, lung cancer, and more.

Table of Contents

What is Cetrelimab?

Cetrelimab, also known by its research code JNJ-63723283, is an investigational drug being developed for cancer treatment. It belongs to a class of medications called immune checkpoint inhibitors, which are a type of immunotherapy[1]. Immunotherapy is a treatment approach that helps your body’s own immune system fight cancer more effectively.

How Does Cetrelimab Work?

Cetrelimab works by targeting a protein called PD-1 (programmed cell death receptor-1) that is found on immune cells. PD-1 normally acts as a “brake” on the immune system to prevent it from attacking healthy cells. However, some cancer cells can use this brake to hide from the immune system. Cetrelimab blocks PD-1, releasing this brake and allowing the immune system to recognize and attack cancer cells more effectively[1].

What Conditions Does Cetrelimab Treat?

Cetrelimab is being studied for the treatment of various types of cancer, including:

  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease[2]
  • Advanced solid tumors: Various types of cancers that form solid masses[3]
  • Urothelial carcinoma: A type of bladder cancer[4]
  • Prostate cancer: Specifically, metastatic castration-resistant prostate cancer (mCRPC), an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy[5]

Current Clinical Trials

Cetrelimab is currently being studied in several clinical trials to evaluate its safety and effectiveness. These trials are investigating cetrelimab both as a standalone treatment and in combination with other drugs. Some notable studies include:

  • A study in patients with chronic hepatitis B virus infection to understand how the drug behaves in the body[1]
  • A trial combining cetrelimab with another drug called amivantamab for non-small cell lung cancer[2]
  • A study using cetrelimab in combination with a new cancer-fighting virus for advanced solid tumors[3]
  • An investigation of cetrelimab with other drugs for bladder cancer[4]
  • Several trials exploring cetrelimab’s potential in treating prostate cancer[5],[6]

Combination Therapies with Cetrelimab

Researchers are exploring how cetrelimab works when combined with other cancer treatments. Some promising combinations include:

  • Cetrelimab + Amivantamab: This combination is being studied for non-small cell lung cancer. Amivantamab is another type of targeted therapy that works differently from cetrelimab[2].
  • Cetrelimab + JNJ-87704916: This combination pairs cetrelimab with an experimental cancer-fighting virus that is injected directly into tumors[3].
  • Cetrelimab + Erdafitinib: This combination is being tested in patients with bladder cancer that has specific genetic changes[4].
  • Cetrelimab + Apalutamide: This combination is being studied for prostate cancer. Apalutamide is a hormone therapy that works by blocking the effects of male hormones on prostate cancer cells[5].
  • Cetrelimab + Niraparib: This combination is also being explored for prostate cancer. Niraparib is a type of drug called a PARP inhibitor, which works by preventing cancer cells from repairing their damaged DNA[6].

Potential Side Effects

As with all medications, cetrelimab can cause side effects. Since it’s still in clinical trials, researchers are carefully monitoring patients for any adverse reactions. Some potential side effects may include:

  • Fatigue
  • Nausea
  • Diarrhea
  • Skin rash
  • Immune-related side effects (due to the immune system becoming overactive)

It’s important to note that not everyone experiences these side effects, and some people may experience different ones. The clinical trials are designed to better understand the safety profile of cetrelimab[2],[5].

How is Cetrelimab Administered?

Cetrelimab is typically given as an intravenous (IV) infusion, which means it’s delivered directly into your bloodstream through a vein. The dosage and frequency can vary depending on the specific clinical trial and the condition being treated. Some common dosing schedules being studied include:

  • 480 mg every 4 weeks[2]
  • 240 mg every 2 weeks[6]

The exact dosing schedule would be determined by your healthcare team if you were to receive this treatment as part of a clinical trial.

Aspect Details
Drug Name Cetrelimab (JNJ-63723283)
Drug Class PD-1 inhibitor immunotherapy
Administration Intravenous infusion
Cancer Types Studied Prostate cancer, bladder cancer, non-small cell lung cancer, hepatitis B-related liver cancer, advanced solid tumors
Combination Therapies Erdafitinib, apalutamide, niraparib, amivantamab, JNJ-87704916 (oncolytic virus), chemotherapy, radiation therapy
Key Outcomes Measured Safety, tolerability, objective response rate, progression-free survival, overall survival, biomarkers
Trial Phases Phase 1, Phase 1b, Phase 2
Notable Features Being studied in various combinations and treatment settings, including neoadjuvant therapy for muscle-invasive bladder cancer

FAQ

  • What is cetrelimab? Cetrelimab is an investigational immunotherapy drug that belongs to a class called PD-1 inhibitors. It works by blocking the PD-1 receptor on immune cells, which helps activate the immune system to recognize and attack cancer cells.
  • What types of cancer is cetrelimab being studied for? Clinical trials are evaluating cetrelimab for various cancer types, including prostate cancer, bladder cancer, non-small cell lung cancer, hepatitis B-related liver cancer, and other advanced solid tumors.
  • How is cetrelimab administered? Cetrelimab is typically administered as an intravenous (IV) infusion. The dosing schedule varies between trials, with some using 240 mg every 2 weeks and others using 480 mg every 4 weeks.
  • What are some of the combination therapies being tested with cetrelimab? Cetrelimab is being studied in combination with other cancer drugs like erdafitinib, apalutamide, niraparib, amivantamab, and JNJ-87704916 (an oncolytic virus). It's also being evaluated alongside chemotherapy and radiation therapy in some trials.
  • What are the main outcomes being measured in cetrelimab trials? Key outcomes include safety and tolerability, objective response rate, progression-free survival, overall survival, and various biomarkers. Researchers are also studying the pharmacokinetics and pharmacodynamics of cetrelimab alone and in combination with other therapies.

Ongoing Clinical Trials on Cetrelimab

  • Study on CD8 PET Imaging for Patients with Metastatic Solid Tumors Using 89Zr-Df-crefmirlimab, Nivolumab, and Cetrelimab

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands Spain

  • Study of Amivantamab and Cetrelimab for Patients with Metastatic Non-Small Cell Lung Cancer

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy Poland Spain

  • Study on Erdafitinib and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for Cisplatin Treatment

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on the Safety and Effectiveness of Erdafitinib Alone or with Cetrelimab and Chemotherapy for Patients with Metastatic or Advanced Urothelial Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on TAR-200 and Cetrelimab for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Who Have Not Received BCG Treatment

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia France Germany Italy The Netherlands +3

  • Study on TAR-200 and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Ineligible for or Refusing Platinum-Based Chemotherapy

    Not recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

  • Study on TAR-200 and Cetrelimab for High-Risk Bladder Cancer Patients Not Responding to BCG and Unable or Unwilling to Have Surgery

    Not recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Greece Italy The Netherlands +2

  • Study of TAR-200 and Cetrelimab for Patients with Muscle-Invasive Bladder Cancer Not Undergoing Radical Cystectomy

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +4

  • Study on Cetrelimab for Patients with Advanced Cancers

    Not recruiting

    1 1
    Investigated drugs:
    Poland Spain

Glossary

  • PD-1 inhibitor: A type of immunotherapy drug that blocks the PD-1 receptor on immune cells, helping to activate the immune system against cancer cells.
  • Metastatic castration-resistant prostate cancer (mCRPC): An advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy that lowers testosterone levels.
  • Urothelial carcinoma: The most common type of bladder cancer that starts in the urothelial cells lining the bladder and urinary tract.
  • Non-small cell lung cancer (NSCLC): A group of lung cancers that includes squamous cell carcinoma, adenocarcinoma, and large cell carcinoma.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • Overall survival (OS): The length of time from the start of treatment until death from any cause.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics: The study of the biochemical and physiological effects of a drug on the body.
  • Dose-limiting toxicity (DLT): Side effects that are severe enough to prevent an increase in the dose of a drug during a clinical trial.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined to be safe and effective for further study in Phase 2 clinical trials.
  • Biomarker: A measurable indicator of a biological state or condition, often used to predict or monitor treatment response in cancer.

References

  1. https://clinicaltrials.gov/study/NCT05242445
  2. https://clinicaltrials.gov/study/NCT05908734
  3. https://clinicaltrials.gov/study/NCT06311578
  4. https://clinicaltrials.gov/study/NCT03473743
  5. https://clinicaltrials.gov/study/NCT03551782
  6. https://clinicaltrials.gov/study/NCT03431350