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Epigenetic Modulator

HBI-8000 + Nivolumab for Melanoma

Phase 3
Recruiting
Led By Agnieszka Malczewski, MD,PhD,FAIC
Research Sponsored by HUYA Bioscience International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have not received anti-PD-1, anti-PD-L1 or other systemic therapy for unresectable or metastatic melanoma
Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 48 months
Awards & highlights

Study Summary

This trial will compare the efficacy and safety of HBI-8000 to placebo when combined with nivolumab for the treatment of unresectable or metastatic melanoma.

Who is the study for?
This trial is for adults and children (12+) with advanced melanoma that hasn't spread to the brain. Participants must not have had prior treatments targeting PD-1/PD-L1 pathways, be willing to use birth control, and able to follow the study plan. They should not have HIV/AIDS, hepatitis B/C, other cancers unless in remission for 2 years, or conditions requiring strong immune system drugs.Check my eligibility
What is being tested?
The study compares HBI-8000 combined with nivolumab against a placebo with nivolumab in patients with unresectable or metastatic melanoma. It's designed to see which treatment is more effective and safe. Patients are grouped based on their PD-L1 expression levels and LDH enzyme amounts.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation of organs, fatigue, skin issues like rash or itching, digestive problems like nausea or diarrhea, potential liver function changes and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had specific immune therapies for advanced melanoma.
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I know my BRAF V600 mutation status or agree to testing.
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My melanoma is confirmed at an advanced stage and cannot be surgically removed.
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I am 18 or older and can care for myself; or I am 12-17 and mostly active.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Secondary outcome measures
Other outcome measures
Other Outcome Measures

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test ArmExperimental Treatment1 Intervention
HBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days
Group II: Control ArmPlacebo Group1 Intervention
Placebo oral BIW + nivolumab IV at specific doses on specific days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HBI-8000 in combination with nivolumab
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

HUYA Bioscience InternationalLead Sponsor
8 Previous Clinical Trials
408 Total Patients Enrolled
1 Trials studying Melanoma
96 Patients Enrolled for Melanoma
HUYABIO International, LLC.Lead Sponsor
11 Previous Clinical Trials
499 Total Patients Enrolled
1 Trials studying Melanoma
96 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,128,984 Total Patients Enrolled
177 Trials studying Melanoma
57,006 Patients Enrolled for Melanoma

Media Library

HBI-8000 (Epigenetic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04674683 — Phase 3
Melanoma Research Study Groups: Test Arm, Control Arm
Melanoma Clinical Trial 2023: HBI-8000 Highlights & Side Effects. Trial Name: NCT04674683 — Phase 3
HBI-8000 (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04674683 — Phase 3

Frequently Asked Questions

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

How many people will be enrolled in this research project at most?

"In order for this study to be completed, 480 individuals who match the pre-specified inclusion criteria are required. These patients can be recruited from different locations, such as Moffitt Cancer Center in Tampa, Florida and AMR Kansas City in Kansas City, Missouri."

Answered by AI

What are typical diseases that HBI-8000 in combination with nivolumab help to improve?

"HBI-8000, in conjunction with nivolumab, can be used to treat aggressive cancers such as malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Are there any know dangers associated with taking HBI-8000 and nivolumab together?

"HBI-8000's safety is rated as a 3 because it is a Phase 3 trial, meaning that, while there is some evidence of efficacy, there is also robust evidence of safety from multiple rounds of testing."

Answered by AI

Are there any availabilities for this clinical trial?

"Yes, this is an accurate summary of the information displayed on clinicaltrials.gov. This particular study is looking for 480 individuals to take part in their clinical trial at 24 different locations."

Answered by AI

Is this trial solely based in the United States or are other countries involved as well?

"This study is being conducted at Moffitt Cancer Center in Tampa, Florida, AMR Kansas City in Kansas City, Missouri, California Cancer Associates for Research and Excellence, Inc. (cCARE) in San Marcos, California, and 24 other locations."

Answered by AI

Are there any other instances where HBI-8000 has been studied in tandem with nivolumab?

"There are 804 studies currently underway looking into the efficacy of HBI-8000 when used in combination with nivolumab. 87 of those studies are in the third and final stage of clinical trials. Most of the research for this treatment is happening in Beijing, but there are 40,581 total locations running trials for this medication."

Answered by AI

Is this the inaugural study of this type?

"As of right now, 804 different ongoing trials are using HBI-8000 in tandem with nivolumab in 2360 cities across 50 nations. The first instance of this combination was back in 2010 and was conducted by Medarex. Only 127 patients were involved in this phase 1 trial. In the past decade, there have been a total of 250 similar studies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma
2021. "Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04674683.
~86 spots leftby Dec 2024
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