Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Trametinib

Dabrafenib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

BGB324 capsules, 200 mg once daily + pembrolizumab 2 mg/kg IV every 3. week

Treatment until disease progression, or unacceptable toxicity

BGB324 capsules: Dose finding part of the study will determine if 100 mg once daily should be used for main part of the study or if 200 mg once daily once daily should be used.

Dabrafenib capsules: 150 mg twice daily Trametinib tablets: 2 mg once daily

Treatment until disease progression, or unacceptable toxicity

Pembrolizumab 2 mg/kg IV every 3. week

Treatment until disease progression, or unacceptable toxicity

Dabrafenib capsules:150 mg twice daily Trametinib tablets: 2 mg once daily

Treatment until disease progression, or unacceptable toxicity

BGB324+pembrolizumab

BGB324+dabrafenib and trametinib

pembrolizumab

dabrafenib and trametinib

Oddbjørn Straume, MD PhD

The purpose of the study is to assess the safety and efficacy of BGB324 given together with standard treatment, pembrolizumab or dabrafenib and trametinib, compared to standard treatment alone,

This is an investigator initiated randomized randomized clinical phase 1b/2 clinical trial comparing safety and efficacy of the Axl inhibitor BGB324 in combination with pembrolizumab or dabrafenib+trametinib with that of pembrolizumab or dabrafenib+trametinib alone. Patients with non-resectable stage III or stage IV melanoma will be stratified based on BRAF mutation and tumor load to start dabrafenib+trametinib (BRAF mutation and high tumor load) or pembrolizumab (BRAF wild type or BRAF mutation and low tumor load) in first line. The patients will be randomized 2:1 to receive BGB324 in combination with pembrolizumab or dabrafenib+trametinib or to receive pembrolizumab or dabrafenib+trametinib alone. A 3+3 dose escalation will be performed for the combination of BGB324 and dabrafenib+trametinib. There is a major focus on predictive markers of treatment response evaluated in blood samples and biopsies.

BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma

A Phase Ib/II Randomised Open Label Study of BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib Compared to Pembrolizumab or Dabrafenib/Trametinib Alone, in Patients With Advanced Non-resectable (Stage IIIc) or Metastatic (Stage IV) Melanoma

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

through study completion, an average of 1 year

through study completion, an average of 2 year

BerGenBio ASA

Haukeland University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma	NCT02872259	Melanoma	BGB324+pembroli... BGB324+dabrafen... pembrolizumab dabrafenib and ...	18 Years -	Haukeland University Hospital
BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma	NCT02872259	Melanoma	BGB324+pembroli... BGB324+dabrafen... pembrolizumab dabrafenib and ...	18 Years -	Haukeland University Hospital
BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma	NCT02872259	Melanoma	BGB324+pembroli... BGB324+dabrafen... pembrolizumab dabrafenib and ...	18 Years -	Haukeland University Hospital

Spots Global Cancer Trial Database for bgb324+dabrafenib and trametinib