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Monoclonal Antibodies

VAY736 for Advanced Cancer (AMBER Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

AMBER Trial Summary

This trial is testing the efficacy and safety of VAY736 in participants with advanced solid tumors.

Who is the study for?
This trial is for individuals with active autoimmune hepatitis (AIH) confirmed by liver biopsy, diagnosed according to international standards, and who haven't fully responded to or can't tolerate standard treatments. It's not for those with advanced cirrhosis, a history of drug-related AIH, recent B-cell depleting therapy use, overlap syndromes like AIH+PBC/PSC, cancer history, or substance abuse.Check my eligibility
What is being tested?
The trial is testing VAY736 in patients with Hepatitis A and Autoimmune Hepatitis. Participants will either receive the actual VAY736 medication or a placebo to compare the effectiveness and safety of this potential new treatment option.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such interventions may cause immune system changes leading to increased infection risk; reactions at injection sites; potential liver enzyme alterations; fatigue; and possibly allergic reactions.

AMBER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ALT (Alanine aminotransferase) normalization
Secondary outcome measures
ALT normalization by dose

Side effects data

From 2018 Phase 2 trial • 27 Patients • NCT02149420
75%
Infusion related reaction
33%
Nasopharyngitis
17%
Headache
8%
Fatigue
8%
Rash
8%
Sinusitis
8%
Cystitis
8%
Iron deficiency anaemia
8%
Back pain
8%
Conjunctivitis
8%
Myalgia
8%
Gastroenteritis
8%
Gastrointestinal infection
8%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
VAY736 10mg/kg
VAY736 3mg/kg
Placebo
Open Label VAY736 10mg/kg

AMBER Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3Experimental Treatment1 Intervention
VAY736 Dose 3
Group II: Arm 2Experimental Treatment1 Intervention
VAY736 Dose 2
Group III: Arm 1Experimental Treatment1 Intervention
VAY736 Dose 1
Group IV: Arm 4Placebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VAY736
2014
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,199,258 Total Patients Enrolled
Marcos Pedrosa, M.D.Study DirectorNovartis Pharmaceuticals
Study DirectorStudy DirectorNovartis Pharmaceuticals
1,221 Previous Clinical Trials
499,906 Total Patients Enrolled

Media Library

VAY736 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03217422 — Phase 2 & 3
Autoimmune Hepatitis Research Study Groups: Arm 1, Arm 2, Arm 4, Arm 3
Autoimmune Hepatitis Clinical Trial 2023: VAY736 Highlights & Side Effects. Trial Name: NCT03217422 — Phase 2 & 3
VAY736 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03217422 — Phase 2 & 3
~9 spots leftby Jun 2025
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