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

Stopped early · Phase 2

Conditions studied: Colorectal Neoplasms

In brief

The purpose of this study was 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.

Key facts

Study ID

NCT04515394

Run by

EMD Serono Research & Development Institute, Inc.

People needed

3

Starts

2021-01-28

Expected to finish

2022-03-31

Last updated by the study team

2022-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moores Cancer Center — La Jolla, California, United States
• University of California, Los Angeles (UCLA) — Santa Monica, California, United States
• Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Hospital — Jacksonville, Florida, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Mayo Clinic — Rochester, Minnesota, United States
• North Shore-LIJ Monter Cancer Center — Lake Success, New York, United States
• Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Scott & White Vasicek Cancer Treatment Center — Temple, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Aurora Cancer Care - Milwaukee West — Wauwatosa, Wisconsin, United States
• Antwerp University Hospital — Antwerp, Belgium
• UZ Leuven — Leuven, Belgium
• Universtity Hospital Brno — Brno, Czechia
• University Hospital Olomouc — Olomouc, Czechia
• Dept. of Oncology Faculty Hospital Motol — Prague, Czechia
• Hospital Na Bulovce — Prague, Czechia
• CHU Besançon Hôpital Jean Minjoz — Besançon, France
• University Hospital of Besançon — Besançon, France
• CHU Estaing — Clermont-Ferrand, France
• CHU Hôpital Henri Mondor — Créteil, France
• Clinique Victor Hugo — Le Mans, France
• CHU de Poitiers — Poitiers, France
• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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