About this trial
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs\* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.
Eligibility criteria
Qualifiers
Adult (age >18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphomawith symptomatic disease progression or progression according to RECIST-criteria after standard anti-cancer treatment or for whom no such treatment is available or indicated.
ECOG performance status 0-2
Patients must have acceptable organ function as defined below. However, specific inclusion/
Disqualifiers
Absolute neutrophil count ≥ 1.5 x 109/l
Hemoglobin > 5.6 mmol/l
Platelets > 75 x 109/l
Total bilirubin < 2 x ULN
Trial design
Treatments tested in this trial
- Panitumumab
- Olaparib
- Dabrafenib
- Nilotinib
- Trametinib
- Erlotinib
- Trastuzumab and Pertuzumab (combination treatment)
- Vemurafenib and Cobimetinib (combination treatment)
- Vismodegib
- Regorafenib
- Nivolumab
- Afatinib
- Dabrafenib and trametinib
- Ribociclib
- Lenvatinib
- Pembrolizumab
- Durvalumab
- Rucaparib
- Axitinib
- Palbociclib
- Crizotinib
- Sunitinib
- Cabozantinib
- Abemaciclib
- Alectinib
- Atezolizumab and Bevacizumab
- Ipilimumab and nivolumab
- Entrectinib
- Talazoparib
- Dacomitinib
- Lorlatinib
- Erdafitinib
- Alpelisib
- Niraparib
- Pemigatinib
- Selpercatinib
- Tepotinib
Treatment groups
37
Treatment groupsSee each treatment group below.
Sponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
Amgen
Collaborator
AstraZeneca
Collaborator
Bayer
Collaborator
Bristol-Myers Squibb
Collaborator
Novartis
Collaborator
Roche Pharma AG
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Boehringer Ingelheim
Collaborator
Ipsen
Collaborator
Eisai Inc.
Collaborator
Pfizer
Collaborator
Clovis Oncology - Pharma and
Collaborator
Eli Lilly and Company
Collaborator
Janssen, LP
Collaborator
GlaxoSmithKline
Collaborator
Incyte Corporation
Collaborator
Dutch Cancer Society
Collaborator
Stelvio for Life
Collaborator