Europas førende søgning efter kliniske forsøg

4-[4-CYANO-2-[[(1’R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2′-CYCLOPROPANE]-1′-CARBONYL]AMINO]PHENYL]BUTANOIC ACID

Clinical trials are investigating 4-[4-CYANO-2-[[(1’R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2′-CYCLOPROPANE]-1′-CARBONYL]AMINO]PHENYL]BUTANOIC ACID in people with advanced colorectal cancer. The study looks at safety, tolerability, and how well the treatment works compared with standard care. It focuses on participants with PD-L1 positive, non MSI-H/dMMR disease.

Table of contents

Trial overview

The available trial investigates 4-[4-CYANO-2-[[(1’R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2′-CYCLOPROPANE]-1′-CARBONYL]AMINO]PHENYL]BUTANOIC ACID in people with PD-L1 positive advanced colorectal cancer.[1] It is an interventional study, which means researchers are giving treatments and then measuring the effects.[1] The study status is Authorised, and the planned enrollment is 144 participants.[1]

Who is being studied

This trial is focused on adults with advanced colorectal cancer that is PD-L1 positive and non MSI-H/dMMR.[1] These terms describe the cancer type and help define the patient group for the study.[1] In simple words, the researchers are looking at a specific subgroup of people with colorectal cancer rather than all patients with this disease.[1]

What is being tested

The study compares two dose levels of 4-[4-CYANO-2-[[(1’R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2′-CYCLOPROPANE]-1′-CARBONYL]AMINO]PHENYL]BUTANOIC ACID with Opdivo plus standard of care versus standard of care alone.[1] The trial also includes other study treatments listed in the data, including bevacizumab, calcium folinate, oxaliplatin, fluorouracil, and Opdivo infusion.[1] The brief summary says the study aims to evaluate both safety and efficacy, which means whether the treatment can be used safely and whether it may help control the cancer better than usual treatment.[1]

Trial phase and design

This is a Phase 2 trial.[1] Phase 2 studies usually focus on early signs of benefit and continue to watch safety closely in a defined patient group.[1] Because this is an interventional study, the researchers actively assign treatment rather than only observing what happens in routine care.[1]

Main outcomes being measured

The primary outcomes include incidence and severity of adverse events and serious adverse events.[1] The study also measures dose interruptions, dose reductions, and drug discontinuations because of treatment-emergent adverse events.[1] Another key outcome is overall response rate by blinded independent central review using RECIST v1.1, which is a standard way to measure how tumors change on scans.[1]

What the study is meant to find out

The main purpose of the trial is to see whether adding 4-[4-CYANO-2-[[(1’R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2′-CYCLOPROPANE]-1′-CARBONYL]AMINO]PHENYL]BUTANOIC ACID to Opdivo and standard of care is safe and whether it may improve results for people with this type of colorectal cancer.[1] The study is also designed to compare the treatment approach with standard care alone, so researchers can judge whether there is a meaningful difference in cancer response.[1] The trial data do not provide final results yet, so the article reflects the study plan rather than outcomes.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519590-19-00 Phase 2 PD-L1 positive advanced colorectal cancer Authorised 144

FAQ

  • Who can take part in the trial? The trial is for participants with PD-L1 positive advanced colorectal cancer. The study data also says the cancer is non MSI-H/dMMR, which describes a specific tumor type.
  • What is being studied in this trial? The study compares two dose levels of 4-[4-CYANO-2-[[(1'R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2'-CYCLOPROPANE]-1'-CARBONYL]AMINO]PHENYL]BUTANOIC ACID with Opdivo plus standard of care versus standard of care alone. It is looking at both safety and how well the treatment works.
  • What phase is the trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may help and how safe it is in a specific patient group.
  • What results are the researchers measuring? The main results include adverse events and serious adverse events, which are unwanted medical problems during the study. The trial also measures dose interruptions, dose reductions, drug discontinuations, and overall response rate by central review using RECIST v1.1.
  • How many people are planned for the study? The planned enrollment is 144 participants. That means the researchers expect to include 144 people in the trial.

Igangværende kliniske forsøg for 4-[4-CYANO-2-[[(1’R,4S)-6-(PROPAN-2-YLCARBAMOYL)SPIRO[2,3-DIHYDROCHROMENE-4,2′-CYCLOPROPANE]-1′-CARBONYL]AMINO]PHENYL]BUTANOIC ACID

  • Undersøgelse af ONO-4578 og nivolumab i kombination med mFOLFOX6 og bevacizumab som førstelinjebehandling hos patienter med fremskreden PD-L1-positiv kolorektal kræft

    Rekrutterer

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig Italien Spanien

Ordliste

  • Advanced colorectal cancer: Cancer of the colon or rectum that has spread or is at a later stage.
  • PD-L1 positive: A test result showing that the tumor has PD-L1, a marker used to describe some cancers.
  • MSI-H: Microsatellite instability-high. This is a tumor feature that helps describe a cancer type.
  • dMMR: Deficient mismatch repair. This means the tumor has a problem fixing DNA mistakes.
  • Phase 2: A clinical trial stage that checks safety and early signs of benefit in a specific group of people.
  • Interventional study: A study where researchers give a treatment and then measure the effects.
  • Standard of care: The usual treatment that is commonly used for a disease.
  • Adverse event (AE): Any unwanted health problem that happens during a study.
  • Serious adverse event (SAE): An unwanted health problem that is severe or may need urgent medical care.
  • Overall response rate (ORR): The percentage of participants whose cancer shrinks or disappears during treatment.
  • RECIST v1.1: A standard way to measure how a tumor changes on scans.
  • Blinded Independent Central Review (BICR): A review of scan results by independent experts who do not know which treatment a person received.

Referencer

  1. https://clinicaltrials.gov/study/2024-519590-19-00