Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    beacon crc

BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment (BERING CRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04673955
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
iOMEDICO AG
Pierre Fabre Pharma AG
Pierre Fabre Pharma Austria
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH

Brief Summary:

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 and Austrian routine setting.


Condition or disease Intervention/treatment
Metastatic Colorectal Carcinoma Drug: Encorafenib Drug: Cetuximab

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Encorafenib and Cetuximab in Patients With Metastatic, BRAFV600E-mutated, Colorectal Carcinoma: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany and Austria
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Encorafenib
    Observation of real-life treatment with encorafenib and cetuximab
  • Drug: Cetuximab
    Observation of real-life treatment with encorafenib and cetuximab


Primary Outcome Measures :
  1. Overall Survival [ Time Frame: At 12 months after start of treatment ]
    Overall Survival rate


Secondary Outcome Measures :
  1. Patient and disease profiles at start of treatment with encorafenib plus cetuximab [ Time Frame: Baseline ]
    Demographic and disease chracteristics

  2. BRAF-mutation assessment [ Time Frame: Baseline ]
    Date and type of BRAFV600E testing

  3. Type and sequence of treatments before and after encorafenib plus cetuximab [ Time Frame: Through study completion, an average of 17 months ]
    Treatment sequence prior to and after encorafenib plus cetuximab

  4. Characteristics of treatment with encorafenib plus cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Evaluation of reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)

  5. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Further Overall Survival parameters

  6. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Best observed tumor response

  7. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Time to progression

  8. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Overall response rate

  9. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Duration of response

  10. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Progression-free-survival

  11. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Disease control rate

  12. Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Duration of disease control

  13. Patient reported outcomes during treatment with encorafenib plus cetuximab - evaluated with EORTC QLQ C-30 [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    EORTC QLQ C-30 questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life C-30 questionnaires) to assess quality of life of cancer patients; comprises 30 items, 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. Only in case of prospective inclusion.

  14. Patient's treatment satisfaction - overall [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    4-point scale: very satisfied, satisfied, dissatisfied, very dissatisfied

  15. Physician's treatment satisfaction - differentiated by efficiency, safety and overall [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    4-point scale: very satisfied, satisfied, dissatisfied, very dissatisfied

  16. Safety and tolerability of treatment with encorafenib and cetuximab - Adverse events and adverse reactions including time to onset and time to resolution [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Number of patients with Adverse Events and maximum grade per patient, Adverse Drug Reactions, Adverse Drug Reactions grade 3/4, Serious Adverse Events, Serious Adverse Drug Reactions

  17. Treatment duration [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)

  18. Treatment dose intensity [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)

  19. Number of treatment interruptions [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)

  20. Duration of treatment interruptions [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with metastatic, BRAFV600E-mutant, colorectal carcinoma, who have received prior systemic therapy, with the decision to receive the doublet therapy encorafenib plus cetuximab according to the current SmPC.
Criteria

Inclusion Criteria:

  • Written informed consent of the patient with regard to the pseudonymized documentation of his/her data in the frame of this non-interventional study
  • Legally capable patient ≥ 18 years of age (no upper limit)
  • Metastatic colorectal carcinoma with BRAFV600E-mutation, pretreated with systemic therapy
  • Decision was taken to treat the patient with the doublet therapy (encorafenib and cetuximab) in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
  • Treatment with the doublet therapy (encorafenib plus cetuximab) has been started ≤ 3 months prior to providing written informed consent for this study or is planned to be started in the near future.

Exclusion Criteria:

  • More than 2 prior systemic regimens in the metastatic setting (adjuvant systemic therapy with relapse ≤ 6 months will be counted as metastatic treatment line; maintenance treatment will not be counted as separate metastatic treatment line)
  • Prior treatment with any RAF-inhibitor or MEK-inhibitor.
  • Presence of any contraindication with regard to the doublet therapy (encorafenib plus cetuximab) as specified in the corresponding SmPCs
  • Current or upcoming participation in an interventional clinical trial
  • Current or upcoming systemic treatment of any other tumor than metastatic colorectal carcinoma
  • Prisoners or persons who are compulsorily detained (involuntarily incarcerated).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673955


Contacts
Layout table for location contacts
Contact: Natalie Mayer, M. Sc. +4976115848 ext 0 natalie.mayer@iomedico.com
Contact: Frank Reichenbach, Dr. rer. nat +4976145261846 ext 0 frank.reichenbach@pierre-fabre.com

Locations
Layout table for location information
Germany
Hospital Recruiting
Aschaffenburg, Germany
Private Practice Recruiting
Berlin, Germany
Private Practice Recruiting
Dresden, Germany
Hospital Recruiting
Esslingen, Germany
Private Practice Recruiting
Heidelberg, Germany
Private Practice Recruiting
Leer, Germany
Private Practice Recruiting
Lübeck, Germany
Private Practice Recruiting
Naunhof, Germany
Private Practice Recruiting
Offenburg, Germany
Private Practice Recruiting
Oldenburg In Holstein, Germany
Private Practice Recruiting
Schorndorf, Germany
Private Practice Recruiting
Würzburg, Germany
Sponsors and Collaborators
Pierre Fabre Pharma GmbH
iOMEDICO AG
Pierre Fabre Pharma AG
Pierre Fabre Pharma Austria
Investigators
Layout table for investigator information
Study Director: Frank Reichenbach, Dr. rer. nat Pierre Fabre Pharma GmbH
Layout table for additonal information
Responsible Party: Pierre Fabre Pharma GmbH
ClinicalTrials.gov Identifier: NCT04673955    
Other Study ID Numbers: NIS-PFO-2020-3101
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pierre Fabre Pharma GmbH:
BRAFV600E mutation
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents