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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

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

Fatigue

Cystitis

Rash

Sinusitis

Iron deficiency anaemia

Back pain

Conjunctivitis

Myalgia

Gastroenteritis

Gastrointestinal infection

Influenza

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,285 Total Patients Enrolled

Marcos Pedrosa, M.D.Study DirectorNovartis Pharmaceuticals

Study DirectorStudy DirectorNovartis Pharmaceuticals

1,207 Previous Clinical Trials

489,612 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people who are 18 or older eligible to participate in this research?

"This particular clinical trial is for patients aged 18 to 75. However, there are 28 trials specifically for people under the age of 18 and 234 trials available for patients over 65."

Answered by AI

To what population does this research project apply?

"This particular clinical trial is enrolling 65 individuals that have been diagnosed with autoimmune hepatitis by the International Autoimmune Hepatitis Group. In order to qualify, patients must also meet the following conditions: an incomplete response to or intolerance of standard therapy according to the AASLD, and a liver biopsy with Ishak modified HAI indicating active AIH."

Answered by AI

What are the predecessors to this research project?

"7 studies involving VAY736 are ongoing in 65 cities and 28 countries. The first trial began in 2018 and was completed in 2020. It was sponsored by Novartis Pharmaceuticals, involved 65 patients, and reached Phase 2 & 3 approval. Since 2018, 18279 other trials have been conducted worldwide."

Answered by AI

What other scientific research has been undertaken using VAY736?

"Currently, there are 7 clinical trials studying VAY736. Of these active studies, 2 have progressed to Phase 3 testing. Most of the research for VAY736 is conducted in Sibu, Sarawak; however, there are 152 locations running trials worldwide."

Answered by AI

Could you please list how many hospitals are part of this research project?

"At the moment, there are 13 different hospitals participating in this clinical trial. If you enroll as a patient, it is recommended that you choose the hospital nearest to your residence to limit travel time and inconvenience."

Answered by AI

Recent research and studies

Expert Review of Clinical ImmunologyJournal

Autoimmune Hepatitis and Pregnancy: Considerations for the Clinician

Chung, Yooyun, Mussarat N Rahim, and Michael A Heneghan. 2022. “Autoimmune Hepatitis and Pregnancy: Considerations for the Clinician”. Expert Review of Clinical Immunology. Informa UK Limited. doi:10.1080/1744666x.2022.2044307.

clinicaltrials.govStudy

ADCC Mediated B-Cell dEpletion and BAFF-R Blockade

2018. "ADCC Mediated B-Cell dEpletion and BAFF-R Blockade". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03217422.

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