Phase II single-arm study of tepotinib combined with cetuximab
Research type
Research Study
Full title
A Phase II single-arm study to investigate tepotinib combined with cetuximab in RAS/BRAF wild-type left-sided metastatic colorectal cancer (mCRC) patients having acquired resistance to anti-EGFR antibody targeting therapy due to MET amplification (PERSPECTIVE)
IRAS ID
285076
Contact name
Stephen Falk
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2020-001776-15
Clinicaltrials.gov Identifier
149637, IND:
Duration of Study in the UK
2 years, 6 months, 12 days
Research summary
This is a research study of an investigational drug called tepotinib that will be given in combination with cetuximab (Erbitux®) that is being evaluated for the treatment of metastatic colorectal cancer (mCRC).
This is a Phase II, open-label study. Phase II means that the study drug is being tested for effectiveness and to see what type of side effects participants may have. Open-label means that the patient and the study doctor will know the treatment received.
The purpose of this research study is to assess the anti-tumour activity, safety, and tolerability of tepotinib in combination with cetuximab in participants with mCRC that has become resistant to standard antibody targeting therapy. Approximately 48 people will participate in this study, which will be conducted in up to 55 hospitals internationally. Study participation will last for approximately 191 days or 6.5 months with a 1-year follow-up period thereafter.
Participants will enter a 56-day Screening period to confirm eligibility.
If eligible, participants will enter the Intervention Period where they will be treated with study drug. The Intervention Period is separated into 3-week cycles and each cycle has 3 study visits. Participation in the Intervention Period will last until disease progression or patient withdrawal.Lay summary of study results:-
A lay summary is not provided. No patients were enrolled in the UK.REC name
West of Scotland REC 1
REC reference
20/WS/0140
Date of REC Opinion
16 Nov 2020
REC opinion
Further Information Favourable Opinion