Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)

  • STATUS
    Recruiting
  • End date
    Mar 23, 2023
  • participants needed
    48
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 26 September 2021
Investigator
US Medical Information
Primary Contact
Foundation IRCCS Casa Sollievo della Sofferenza (0.0 mi away) Contact
+66 other location

Summary

The purpose of this study is to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification.

Details
Condition Colorectal Cancer, Rectal disorder, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, colorectal neoplasm, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Cetuximab, tepotinib
Clinical Study IdentifierNCT04515394
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced (locally advanced or metastatic) left sided (from splenic flexure to rectum - National Comprehensive Cancer Network [NCCN] version 4.2020) colorectal cancer (CRC) with RAS/BRAF wild-type at study entry confirmed prior to enrollment, with previous anti-epidermal growth factor receptor (anti-EGFR) therapy and acquired resistance on the most recent anti-EGFR monoclonal antibody therapy (panitumumab or cetuximab) by radiological documentation of disease progression according to RECIST Version 1.1
Mesenchymal epithelial transition (MET) amplification detected by a positive liquid biopsy and/or tissue with appropriate regulatory status (collected after disease progression of the previous anti-EGFR therapy)
Measurable disease by Investigator in accordance with RECIST Version 1.1
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Life expectancy greater than 3 months
Participants having at least one systemic treatment for mCRC including 1 anti-EGFR monoclonal antibody therapy as the most recent line of therapy for mCRC before study treatment and must have shown a radiologically confirmed by RECIST Version 1.1 complete response (CR) or partial response (PR), both for at least 4 months or stable disease (SD) for at least 6 months to that therapy prior to disease progression
Less than 2 months between the last administration of the most recent EGFR containing regimen and first dosing in this study
Adequate hematological function, hepatic and renal functions as defined in the protocol
Signed and dated informed consent indicating that the participants had been informed of all the pertinent aspects of the trial prior to enrollment
Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies
Other protocol defined inclusion criteria could apply

Exclusion Criteria

Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS metastases. Also excluded are participants with carcinomatous meningitis
Participants who have brain metastasis as the only measurable lesion
Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for anti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of study intervention, except for the anti-EGFR containing regimen including associated chemotherapy if applicable, which may be continued until enrollment of the participant in the study
Any unresolved toxicity Grade 2 or more according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, from previous anticancer therapy excluding neuropathy, alopecia and rash
Severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to [>=] 3 NCI-CTCAE v 5.0), any history of anaphylaxis, or uncontrolled asthma (i.e., 3 or more occurrences of partially controlled asthma)
Discontinuation of the most recent cetuximab or panitumumab containing therapy due to an adverse event
Prior treatment with other agents targeting the hepatocyte growth factor (HGF)/Mesenchymal epithelial transition (MET) pathway
Impaired cardiac function: Left ventricular ejection fraction less than [<] 45 percent [%] defined by echocardiography (a screening assessment not required for participants without a history of congestive heart failure unless clinically indicated); Serious arrhythmia; Unstable angina pectoris; New York Heart Association heart failure Class III and IV; Myocardial infarction within the last 12 months prior to study entry and Symptomatic pericardial effusion; Corrected QT interval by Fridericia (QTcF) greater than (>) 480 milliseconds (ms)
Hypertension uncontrolled by standard therapies (not stabilized to less than [< ]150/90 millimeter of mercury [mmHg])
History of neoplasm other than mCRC
History of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the test products
Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus
Major surgery within 28 days prior to Day 1 of study intervention
History of Interstitial lung disease (ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment
Other protocol defined exclusion criteria could apply
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