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

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE)

ClinicalTrials.gov ID

NCT04515394

Acronym / sponsor ID

MS202202_0002

Conditions

Colorectal Neoplasms

Keywords

Colorectal cancer, RAS wild-type, Tepotinib, Cetuximab, Erbitux, Epidermal growth factor receptor resistance, Hepatocyte growth factor, Panitumumab

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: The study was terminated early due to operational challenges identifying suitable participants for screening in the study.

Enrolment

3 participants (actual)

Lead sponsor

EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)

Collaborators

Merck KGaA, Darmstadt, Germany

Study start

28 Jan 2021 (actual)

Primary completion

14 Mar 2022 (actual)

Study completion

31 Mar 2022 (actual)

First posted

17 Aug 2020 (actual)

Results

Posted 22 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0

   Time frame: Day 1 to Day 21 of Cycle 1 (each cycle is of 21 days)

   DLTs are defined as any of the following toxicities and judged by Investigator and/ Sponsor to be not attributable to the disease/disease-related processes under investigation: Grade 4 neutropenia for more than 7 days; Grade greater than or equal to [>=] 3 febrile neutropenia with absolute neutrophil count < 1000 per cube millimeter (per mm^3) and a single temperature of > 38.3 degree Celsius/a sustained temperature of >= 38 degree Celsius for more than 1 hour; Grade 4/Grade 3 thrombocytopenia with non-traumatic bleeding; Grade 3 uncontrolled nausea/vomiting and/diarrhea that has not improved within 72 hours despite adequate and optimal treatment; Grade 4 vomiting and/diarrhea; Grade >= 3 skin toxicity that has not resolved to Grade 2 after 14 days of adequate treatment; Any other Grade >= 3 non-hematological AE will be defined as DLT. Exceptions are alopecia/an isolated lipase and/amylase elevation of Grade >= 3 without clinical/radiological evidence of pancreatitis.

2. Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigators

   Time frame: Time from first study treatment assessed up to 218 days

   OR is defined as a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all target lesions.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Trial Awareness and Transparency websiteLink provided by the sponsor.
• US Medical Information website, Medical ResourcesLink provided by the sponsor.
• Targeting MET Clinical Trial ProgramLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

65 sites in 8 countries: see every site and its status.