A comparison of the effects of standard melanoma treatment in combination with BGB324, an investigational agent, to standard treatment alone

Phase 1

• Conditions: Advanced non-resectable (Stage IIIc) or metastatic (Stage IV) melanoma; MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002615-15-NO
• Lead Sponsor: Helse Bergen HF, Haukeland universitetssjukehus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-20
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Inclusion Criteria
1.Patients able to understand and willing to sign a written protocol specific informed consent and older than 18 years at the time of consent.
2.Histologically confirmed advanced cutaneous melanoma that is either non-resectable (Stage IIIc) or metastatic (Stage IV) with:
a.At least one measurable lesion as defined by RECIST 1.1 on CT or MRI scan and
b.Documented progression of =1 measurable lesion
3.ECOG performance status 0 to 2 at screening
4.Availability of fresh or archival tumour tissue sample suitable for evaluation of predictive biomarkers of response
5.Male patients with female partners of childbearing potential and female patients of childbearing potential willing to practice highly effective birth control while onfrom screening, throughout the study and for at least 3 months following the last dose of study treatment (and if female of childbearing potential, has a negative serum pregnancy test in the 7 days before the first dose of BGB324study treatment)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1.Prior first line systemic treatment for the treatment of Stage IIIb or Stage IIIc melanoma, including BRAF or MEK inhibitor
2.Symptomatic central nervous system metastatic lesions as determined by Investigator
3.History of malignancy other than melanoma within the last 2 years (basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; isolated elevation in prostate specific antigen in the absence of histological or radiographic evidence of prostate cancer is allowed)
4.History of or current active autoimmune diseases. Patients with vitiligo, or other non-serious autoimmune diseases based on the Investigator’s assessment, are NOT excluded
5.FOR BRAF pos PATS: History of retinal vein occlusion (RVO) or ongoing retinal pigment epithelial detachment (RPED)
6.History of the following cardiac conditions:
a.Congestive cardiac failure of >Grade 2 severity according to the New York Heart Association (defined as symptomatic at less than ordinary levels of activity)
b.Ischemic cardiac event including myocardial infarction within 3 months prior to first dose of study treatment
c.Uncontrolled cardiac disease, including unstable angina, uncontrolled hypertension or need to change medication within 6 weeks of provision of consent due to lack of disease control
d.History or presence of sustained bradycardia (=55 bpm), left bundle branch block, cardiac pacemaker or ventricular arrhythmia. Note: Patients with a supraventricular arrhythmia requiring medical treatment, but with a normal ventricular rate are eligible
e.Family history of long QTc syndrome; personal history of long QTc syndrome or previous drug-induced QTc prolongation
7.Abnormal left ventricular ejection fraction on echocardiography or Multi Gated Acquisition (MUGA) Scan (MUGA) (less than the lower limit of normal for a patient of that age at the treating institution or <45%, whichever is lower)
8.Current treatment with any agent known to cause Torsade de Points which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment
9.Screening 12-lead ECG with a measurable QTc interval calculated according to Fridericia’s correction (QTcF) >450ms
10.Inadequate organ function as defined by the following laboratory values:
a.Haematological: absolute neutrophil count =1.5 x 109/L, platelets =100 x 109/L, haemoglobin =9.0 g/dL
b.Renal: serum creatinine =1.5 x institutional upper limit of normal (ULN) and estimated glomerular filtration rate of =50 mL/minute
c.Hepatic: total bilirubin =1.5 x institutional ULN, alanine transaminase and aspartate transaminase =2.5 x institutional ULN or =5.0 x institutional ULN if liver metastases are present
d.Coagulation: international normalized ratio or prothrombin time and activated partial thromboplastin time =1.5 x institutional ULN if not using anticoagulants (if patient is receiving anticoagulant therapy value must be within therapeutic range for the condition being treated)
11.Ongoing infection requiring systemic treatment. Patients who are on prophylactic anti infectives or who have been afebrile for 48 hours following the initiation of treatment are eligible
12.Known active infection with human immunodeficiency virus (HIV), hepatitis B or C viruses (screening not required)
•Patients who have a history of hepatitis B infection are eligible provided they are hepatitis B surface antigen negative
•Patients who have a history of hepatitis C infection are eligible provided they have no evi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified