Actively Recruiting
BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
Led by Pierre Fabre Pharma GmbH · Updated on 2022-09-29
500
Participants Needed
70
Research Sites
330 weeks
Total Duration
On this page
Sponsors
P
Pierre Fabre Pharma GmbH
Lead Sponsor
I
iOMEDICO AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
The presence of a BRAFV600E mutation is a marker of poor prognosis in patients with mCRC and associated with a median overall survival (mOS) of approximately 12 to 14 months compared to 20 to 25 months for patients with BRAF wild-type tumours. After 1st line therapy, treatment outcomes with standard therapy are poor in patients with BRAF-mutated mCRC, with response rates (ORR) of ≤ 11%, a median progression-free survival (mPFS) between 1.8 and 2.8 months, and a mOS between 4.1 and 6.2 months. Failure to achieve adequate survival outcomes with standard treatment regimens in patients with BRAF-mutated mCRC has encouraged efforts to combine multiple targeted therapies: With 665 randomized patients, the BEACON CRC trial represents the largest trial and is currently the only phase III study in patients with BRAFV600E-mutant mCRC. BERING CRC - designed as a prospective (allowing initial retrospective documentation), longitudinal, non-interventional study - will investigate the real-world effectiveness, quality of life, safety and tolerability of encorafenib and cetuximab in BRAFV600E-mutant mCRC patients, who have received prior systemic therapy. Data from this study will contribute to a deeper understanding and characterization to the everyday use of encorafenib and cetuximab in a broader patient population in the German, Austrian, and Swiss routine setting.
CONDITIONS
Official Title
BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient provides written informed consent for pseudonymized data collection in this non-interventional study
- Patient is legally capable and 18 years of age or older
- Diagnosed with metastatic colorectal carcinoma with a BRAFV600E mutation
- Patient has been pretreated with systemic therapy
- Decision to treat with encorafenib and cetuximab doublet therapy was made before and independently of study inclusion
- Treatment with encorafenib plus cetuximab started within 3 months before consent or is planned to start soon
You will not qualify if you...
- More than two prior systemic treatment regimens in the metastatic setting (adjuvant therapy relapse within 6 months counts as metastatic treatment; maintenance therapy does not count separately)
- Previous treatment with any RAF-inhibitor or MEK-inhibitor
- Any contraindication to encorafenib plus cetuximab as per their prescribing information
- Current or planned participation in another interventional clinical trial
- Current or planned systemic treatment for any tumor other than metastatic colorectal carcinoma
- Prisoners or involuntarily detained persons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 70 locations
1
Clinic
Braunau am Inn, Upper Austria, Austria, 5280
Actively Recruiting
2
Clinic
Linz, Upper Austria, Austria, 4010
Actively Recruiting
3
Clinic
Feldkirch, Voralberg, Austria, 6807
Actively Recruiting
4
Clinic
Vienna, Austria, 1090
Actively Recruiting
5
Practice
Offenburg, Baden-Wurttemberg, Germany, 77654
Actively Recruiting
6
Medical Care Centre
Ulm, Baden-Wurttemberg, Germany, 89073
Actively Recruiting
7
Clinic
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
8
Practice
Augsburg, Bavaria, Germany, 86150
Actively Recruiting
9
Practice
Donauwörth, Bavaria, Germany, 86609
Actively Recruiting
10
Clinic
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
11
Practice
München, Bavaria, Germany, 81241
Actively Recruiting
12
Practice
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
13
Medical Car Centre
Aschaffenburg, Bayer, Germany, 63739
Actively Recruiting
14
Medical Care Centre
Potsdam, Brandenburg, Germany, 14467
Actively Recruiting
15
Practice
Celle, Lower Saxony, Germany, 29221
Actively Recruiting
16
Medical Care Centre
Goslar, Lower Saxony, Germany, 38642
Actively Recruiting
17
Practice
Göttingen, Lower Saxony, Germany, 37073
Actively Recruiting
18
Medical Practice
Hanover, Lower Saxony, Germany, 30161
Actively Recruiting
19
Practice
Hanover, Lower Saxony, Germany, 30161
Actively Recruiting
20
Practice
Leer, Lower Saxony, Germany, 26789
Actively Recruiting
21
Clinic
Weißenfels, Lower Saxony, Germany, 26121
Actively Recruiting
22
Medical Practice
Wilhelmshaven, Lower Saxony, Germany, 26389
Actively Recruiting
23
Practice
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Actively Recruiting
24
Practice
Rostock, Mecklenburg-Vorpommern, Germany, 18107
Actively Recruiting
25
Clinic
Rostock, Melcklenburg-Vorpommern, Germany, 18059
Actively Recruiting
26
Clinic
Aachen, North Rhine-Westphalia, Germany, 52074
Actively Recruiting
27
Clinic
Bochum, North Rhine-Westphalia, Germany, 44791
Actively Recruiting
28
Practice
Bonn, North Rhine-Westphalia, Germany, 53123
Actively Recruiting
29
Clinic
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
30
Practice
Bottrop, North Rhine-Westphalia, Germany, 46236
Actively Recruiting
31
Clinic
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
32
Practice
Moers, North Rhine-Westphalia, Germany, 47441
Actively Recruiting
33
Medical Care Centre
Mönchengladbach, North Rhine-Westphalia, Germany, 41239
Actively Recruiting
34
Medical Care Centre
Mülheim, North Rhine-Westphalia, Germany, 45468
Actively Recruiting
35
Medical Care Centre
Neuss, North Rhine-Westphalia, Germany, 41462
Actively Recruiting
36
Clinic
Paderborn, North Rhine-Westphalia, Germany, 33098
Actively Recruiting
37
Medical Care Centre
Porta Westfalica, North Rhine-Westphalia, Germany, 32457
Actively Recruiting
38
Practice
Stolberg, North Rhine-Westphalia, Germany, 52222
Actively Recruiting
39
Practice
Troisdorf, North Rhine-Westphalia, Germany, 53840
Actively Recruiting
40
Clinic
Wuppertal, North Rhine-Westphalia, Germany, 42283
Actively Recruiting
41
Practice
Bad Kreuznach, Rhineland-Palatinate, Germany, 55543
Actively Recruiting
42
Practice
Kaiserslautern, Rhineland-Palatinate, Germany, 67655
Actively Recruiting
43
Practice
Worms, Rhineland-Palatinate, Germany, 67547
Actively Recruiting
44
Clinic
Saarbrücken, Saarland, Germany, 66113
Actively Recruiting
45
Practice
Dresden, Saxony, Germany, 01307
Actively Recruiting
46
Prctice
Naunhof, Saxony, Germany, 04683
Actively Recruiting
47
Clinic
Torgau, Saxony, Germany, 04860
Actively Recruiting
48
Practice
Halle, Saxony-Anhalt, Germany, 06110
Actively Recruiting
49
Clinic
Köthen, Saxony-Anhalt, Germany, 06366
Actively Recruiting
50
Practice
Köthen, Saxony-Anhalt, Germany, 06366
Actively Recruiting
51
Clinic
Flensburg, Schleswig-Holstein, Germany, 24939
Actively Recruiting
52
Clinic
Eisenach, Thuringia, Germany, 99817
Actively Recruiting
53
Hospital
Aschaffenburg, Germany
Actively Recruiting
54
Medical Care Centre
Berlin, Germany, 10407
Actively Recruiting
55
Practice
Berlin, Germany, 10707
Actively Recruiting
56
Practice
Berlin, Germany, 10715
Actively Recruiting
57
Clinic
Berlin, Germany, 12559
Actively Recruiting
58
Private Practice
Berlin, Germany
Actively Recruiting
59
Private Practice
Dresden, Germany
Actively Recruiting
60
Hospital
Esslingen am Neckar, Germany
Actively Recruiting
61
Practice
Hamburg, Germany, 10259
Actively Recruiting
62
Practice
Hamburg, Germany, 20259
Actively Recruiting
63
Private Practice
Heidelberg, Germany
Actively Recruiting
64
Private Practice
Leer, Germany
Actively Recruiting
65
Private Practice
Lübeck, Germany
Actively Recruiting
66
Private Practice
Naunhof, Germany
Actively Recruiting
67
Private Practice
Offenburg, Germany
Actively Recruiting
68
Private Practice
Oldenburg in Holstein, Germany
Actively Recruiting
69
Private Practice
Schorndorf, Germany
Actively Recruiting
70
Private Practice
Würzburg, Germany
Actively Recruiting
Research Team
M
Marion Schmoll
CONTACT
F
Frank Reichenbach, Dr. rer. nat
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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