Study Comparing HBI-8000 and Nivolumab with Placebo and Nivolumab in Patients with Advanced Melanoma
Sponsor: HUYABIO International, LLC.
ClinicalTrials ID:NCT04674683
This clinical trial is testing whether the combination of HBI-8000 and nivolumab is more effective and safe compared to a placebo with nivolumab in patients with advanced melanoma. It also includes a special group of patients with brain metastases to receive HBI-8000 and nivolumab.
Patient Parameters
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Program Overview
The study aims to compare the effectiveness and safety of the drug HBI-8000 combined with nivolumab against a placebo combined with nivolumab in patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body. There is also a separate group for adults with new or worsening brain metastases and adolescents with or without brain metastases, who will receive HBI-8000 and nivolumab.
Description
This study involves multiple centers and is divided into two main parts. In the main study, patients are randomly assigned to receive either HBI-8000 or a placebo, both combined with nivolumab. The assignment is based on specific factors like PD-L1 expression and LDH levels. Patients will receive treatment in cycles of 28 days, with HBI-8000 or placebo taken orally twice a week and nivolumab given through an IV on the first day of each cycle. Treatment continues for up to two years or until the disease progresses, side effects become unacceptable, or the patient decides to stop.
In a separate group, adults with new or worsening brain metastases and adolescents with or without brain metastases will receive HBI-8000 and nivolumab without randomization. The treatment schedule is similar to the main study, with adjustments for adolescents under 40 kg.
The study aims to determine if HBI-8000 combined with nivolumab can better control melanoma compared to the placebo combination.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced melanoma that cannot be removed by surgery or has spread, and not affecting the eye.
- Known BRAF V600 mutation status or willing to be tested for it.
- Tumor tissue available for PD-L1 testing.
- Aged 12 years or older.
- Good overall health with specific performance status scores.
- At least one measurable tumor separate from the biopsy site.
- No prior treatment with certain immune therapies for melanoma.
- Completed any prior radiotherapy or minor surgery at least 2 weeks before starting the study.
- Meet specific blood test criteria.
- Negative pregnancy test for women of childbearing potential.
- Agree to use effective birth control during and after the study.
- Willing to sign informed consent and comply with study requirements.
Exclusion Criteria
- Severe allergic reactions to similar drugs.
- Previous treatment with certain immune therapies for melanoma.
- Organ transplant recipients.
- Recent serious heart conditions.
- Uncontrolled high blood pressure.
- Active or worsening brain metastases, unless part of the special group.
- Certain digestive disorders affecting drug absorption.
- Active autoimmune diseases, except for specific conditions.
- Active infections requiring treatment.
- Positive for HIV or hepatitis B/C.
- Chronic use of steroids or immunosuppressive drugs.
- Recent use of other investigational drugs.
- Pregnant or breastfeeding women.
- History of other cancers unless in remission or treated with curative intent.
- Use of certain medications affecting liver enzymes.
- Uncontrolled adrenal or liver disease.
- Recent live vaccinations.
- Medical conditions that could interfere with the study.
- History of lung diseases like interstitial lung disease.
- Prior organ or cell transplants.
- Sensitivity to study drugs.
- Recent radiation therapy.
- Use of drugs affecting heart rhythm.
- Inability to comply with study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Comprehensive Blood and Cancer Center | 93309 | Bakersfield | California |
| UC San Diego Moores Cancer Center | 92037 | La Jolla | California |
| Innovative Clinical Research Institute (ICRI) | 91105 | Pasadena | California |
| Emad Ibrahim, MD, INC | 92373 | Redlands | California |
| Kaiser Permanente Oncology Research | 92505 | Riverside | California |
| California Cancer Associates for Research and Excellence, Inc. (cCARE) | 92069 | San Marcos | California |
| Boca Raton Regional Hospital, Lynn Cancer Institute | 33486 | Boca Raton | Florida |
| Memorial Regional Hospital | 33021 | Hollywood | Florida |
| Baptist MD Anderson Cancer Center | 32207 | Jacksonville | Florida |
| Orlando Health | 32806 | Orlando | Florida |
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