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POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC

Study acronym: POTENT
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v8
  2. Minor Primary completion date: Feb 1, 2028 to Mar 8, 2028
    • Study completion date: Feb 1, 2028 to Jan 9, 2029
    • Eligibility criteria expanded, about 80 words
    • Site details revised at 1 of 4 sites
    v7
  3. Notable Enrollment target: 38 to 19
    • Site contacts updated at 2 of 4 sites
    • Collaborators: 1 to 2
    v6
  4. Minor Study sites: 1 to 4
    • Collaborators: 2 to 1
    v5
  5. Minor Site contact updatedv4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 9, 2023 to May 3, 2023
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical study is looking at the combination of two experimental drugs called tepotinib and pembrolizumab. Pembrolizumab, also known as Keytruda, is licenced and available by prescription to treat a variety of cancers. Tepotinib is currently licensed in the UK for use in non-small cell lung cancer (NCSLC) and is being investigated for this purpose. Cancer immunotherapy drugs hold great promise but still do not work for many patients. Laboratory studies on cancers that do not respond well to immunotherapy reveal that most of these tumours do not have any immune cells. This suggests that the cancer has successfully hidden itself and avoided being recognised by the immune system. This study aims to use a novel approach using a targeted drug, tepotinib, to target the gene involved with NSCLC. Tepotinib is a type of drug called a kinase inhibitor. Kinase inhibitors are a newer type of drug being used to try to treat cancers. They act by blocking some of the chemical messengers that are part of the signalling process within cancer cells that control their growth. Tepotinib is used in adults to treat NSCLC that can have certain abnormal changes in the mesenchymal-epithelial transition factor gene (MET) and which has spread and/or cannot be removed by surgery. The changes in the MET gene can make an abnormal protein which can lead to uncontrolled cell growth and cancer. By blocking this abnormal protein, tepotinib may slow or stop the cancer from growing as well as potentially shrinking the cancer. This study will include patients with and without the MET exon 14 mutations. In this clinical study, the investigators aim to test our ideas in a small number of people for the first time, specifically in those patients with cancers which do not respond to cancer immunotherapy.
Trial Details
NCT Number NCT05782361
Lead Sponsor Institute of Cancer Research, United Kingdom
Collaborators: Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany
Conditions
(from sponsor)
Advanced Cancer, Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov