A NON-INTERVENTIONAL STUDY TO INVESTIGATE THE EFFECTIVENESS, SAFETY AND UTILIZATION OF COBIMETINIB AND VEMURAFENIB IN PATIENTS WITH AND WITHOUT BRAIN METASTASIS WITH BRAF V600 MUTANT MELANOMA UNDER REAL WORLD CONDITIONS (coveNIS)

Study identification

• EU PAS number:
  EUPAS18539
• Study ID:
  47801
• Official title and acronym:
  A NON-INTERVENTIONAL STUDY TO INVESTIGATE THE EFFECTIVENESS, SAFETY AND UTILIZATION OF COBIMETINIB AND VEMURAFENIB IN PATIENTS WITH AND WITHOUT BRAIN METASTASIS WITH BRAF V600 MUTANT MELANOMA UNDER REAL WORLD CONDITIONS (coveNIS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This prospective multi-center non-interventional study will include patients with an underlying diagnosis of BRAF V600 mutated unresectable or metastatic malignant melanoma, either with or without cerebral metastases. Data collection during therapy with Cobimetinib / Vemurafenib should reflect clinical routine. Study duration will be three years. Data from individual patients will be documented up to three years.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:28/02/2017

Study start date

Planned:30/06/2017

Actual:21/06/2017

Date of final study report

Planned:30/04/2022

Actual:21/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ML39302