BridgeMD
A study in patients with skin cancer
EU CTIS ID: 2024-516914-39-00
What this study is testing
To compare, between Test (HBI-8000 + nivolumab) and Control (placebo + nivolumab) arms: Progression-free Survival (PFS), defined as the time (in days) from the date of randomization to the first date of documented disease progression according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as determined by BIRC, or the date of death due to any cause, whichever occurs first.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma according to AJCC staging system (8th edition).
- Negative serum pregnancy test at baseline for women of childbearing potential (WOCBP).
- Females of childbearing potential (non-surgically sterile or premenopausal female capable of becoming pregnant) and all males (due to potential risk of drug exposure through the ejaculate) must agree to use an adequate method of contraception including a highly effective method and a barrier method during the study and for 5 months after the last dose of Study Drug. Highly effective contraception used by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to Section 8.3 for details and definitions of WOCBP, postmenopausal females, and contraception guidance
- Have the ability to understand and the willingness to sign a written informed consent document, comply with study scheduled treatment, visits and assessments.
- Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization.
- Tumor tissue available for PD-L1 testing at central Laboratory or local laboratory; results must be obtained prior to randomization. In the event when archived tumor tissue is not available, new tumor biopsy or historical PD-L1 test results may be used for randomization, however tumor tissue, either taken previously or newly acquired, must be provided for central biomarker confirmation for final data analyses. PD-L1 expression level is required for randomization. In order to be randomized, a patient must be classified as PD-L1 positive or PD-L1 negative according to the following criteria: • PD-L1 positive (≥1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells) vs • PD-L1 negative (< 1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells) Note: If an insufficient amount of tumor tissue is available prior to the start of the Screening phase, patients must consent to allow the acquisition of additional tumor tissue for performance of biomarker analyses.
You likely can't join if
- History of ≥ Grade 3 hypersensitivity reactions to monoclonal antibodies.
- Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS).
- Hepatitis B surface antigen positive or hepatitis C antibody positive. Further investigation per institutional practices may be performed to exclude active infection.
- Patients with a condition requiring chronic systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days before administration of Study Treatment. Inhaled or topical steroids, or adrenal replacement dose of corticosteroids at dose ≤10 mg/day prednisone (or equivalent) are permitted.
- Use of other investigational agent (drug or vaccine not marketed for any indication) within 28 days before administration of Study Treatment. If the investigational agent is a monoclonal antibody, then use within 3 months, before administration of Study Treatment
- Pregnant or breast-feeding women.
See the full eligibility criteria
Who can join
- Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma according to AJCC staging system (8th edition).
- Negative serum pregnancy test at baseline for women of childbearing potential (WOCBP).
- Females of childbearing potential (non-surgically sterile or premenopausal female capable of becoming pregnant) and all males (due to potential risk of drug exposure through the ejaculate) must agree to use an adequate method of contraception including a highly effective method and a barrier method during the study and for 5 months after the last dose of Study Drug. Highly effective contraception used by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to Section 8.3 for details and definitions of WOCBP, postmenopausal females, and contraception guidance
- Have the ability to understand and the willingness to sign a written informed consent document, comply with study scheduled treatment, visits and assessments.
- Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization.
- Tumor tissue available for PD-L1 testing at central Laboratory or local laboratory; results must be obtained prior to randomization. In the event when archived tumor tissue is not available, new tumor biopsy or historical PD-L1 test results may be used for randomization, however tumor tissue, either taken previously or newly acquired, must be provided for central biomarker confirmation for final data analyses. PD-L1 expression level is required for randomization. In order to be randomized, a patient must be classified as PD-L1 positive or PD-L1 negative according to the following criteria: • PD-L1 positive (≥1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells) vs • PD-L1 negative (< 1% tumor cell membrane staining in a minimum of a hundred evaluable tumor cells) Note: If an insufficient amount of tumor tissue is available prior to the start of the Screening phase, patients must consent to allow the acquisition of additional tumor tissue for performance of biomarker analyses.
- Males or females 12 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 for age ≥18 years, Lansky performance status ≥80% for age 12-17 years.
- At least one measurable lesion defined by RECIST 1.1 criteria separate from the lesion to be used for tumor tissue collection for PDL1 testing, not counting brain metastasis with: • Longest diameter ≥10 mm by computed tomography (CT) (when slice thickness is ≤5 mm); or ≥ 2 × slice thickness (when slice thickness is >5 mm) • Pathologically enlarged lymph node: ≥15 mm in short axis by CT (when slice thickness is ≤5 mm) • Clinical: ≥10 mm (that can be accurately measured with calipers) (refer to Appendix 5)
- Have not received anti-PD-1, anti-PD-L1 or other systemic therapy for unresectable or metastatic melanoma, except for the following, provided that the patient recovered from all treatment related toxicities: a. BRAF mutation targeted therapy >4 weeks before administration of Study Treatment. b. Adjuvant or neoadjuvant therapy with PD-1 or PD-L1 inhibitors, anti- cytotoxic T lymphocyte-associated protein 4 (CTLA4) is allowed if disease progression/or recurrence had occurred at least 6 months after the last dose of neoadjuvant/adjuvant therapy and prior to receiving the first dose on this study and no clinically significant immune related toxicities leading to treatment discontinuation were observed. c. Adjuvant interferon therapy must have been completed >6 weeks before administration of Study Treatment
- Any prior radiotherapy or minor surgery must be completed at least 2 weeks and 1 week respectively before Day 1 dosing and recovered from all treatment related toxicities.
- Screening laboratory results within 14 days prior to randomization: a. Hematology: white blood cells (WBC) ≥3000/μL, neutrophils ≥1500/μL, platelets ≥100 × 103/μL, hemoglobin ≥10.0 g/dL independent of transfusion. The use of erythropoietic growth factor to achieve Hgb ≥10 g/dl is acceptable. b. CrCL ≥30 mL/min using Cockcroft-Gault formula Appendix 3 [Cockcroft and Gault, 1976]. c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), alkaline phosphatase ≤2.5 × ULN unless bone metastases present (patients with documented bone metastases: alkaline phosphatase <5 × ULN), bilirubin ≤1.5 × ULN (unless known Gilbert’s disease where it must be ≤3 × ULN), serum albumin ≥3.0 g/dL.
What rules you out
- History of ≥ Grade 3 hypersensitivity reactions to monoclonal antibodies.
- Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS).
- Hepatitis B surface antigen positive or hepatitis C antibody positive. Further investigation per institutional practices may be performed to exclude active infection.
- Patients with a condition requiring chronic systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days before administration of Study Treatment. Inhaled or topical steroids, or adrenal replacement dose of corticosteroids at dose ≤10 mg/day prednisone (or equivalent) are permitted.
- Use of other investigational agent (drug or vaccine not marketed for any indication) within 28 days before administration of Study Treatment. If the investigational agent is a monoclonal antibody, then use within 3 months, before administration of Study Treatment
- Pregnant or breast-feeding women.
- Have a history of any other malignancy unless in remission for 2 years, or locally curable cancers that have been treated with curative intent with no evidence of recurrence, such as: • Basal or squamous cell skin cancer • Superficial bladder cancer • Carcinoma in situ of cervix or breast • Incidental prostate cancer • Non-melanomatous skin cancer • Prostate cancer treated with curative intent with serum prostate-specific antigen (PSA) <2.0 ng/mL
- Patients with medical conditions requiring administration of strong cytochrome P450 (CYP) 3A4 Inducers and Inhibitors with no alternative therapy.
- Uncontrolled adrenal insufficiency or active chronic liver disease.
- Has received approved live vaccine/ live attenuated vaccines within 30 days of planned Cycle 1 Day 1. Inactivated viral vaccines or vaccines based on subviral component are allowed; however intranasal influenza vaccines (e.g. Flu-Mist) are not allowed. Coronavirus disease 2019 COVID-19 vaccination should be administered at least 7 days before Cycle 1 Day 1.
- Underlying medical conditions that, in the Investigator’s opinion, will make the administration of Study Treatment hazardous or obscure the interpretation of toxicity determination or adverse events.
- Previous treatment with a PD-1, PD-L1, PD-L2, CTLA-4 inhibitor, or any other agents targeting T-cell co-stimulation or immune checkpoint pathways for unresectable or metastatic melanoma.
- Patients with a history of or active interstitial lung disease (ILD) or non-infectious pneumonitis.
- Patient with prior organ or hematopoietic cell transplant (HCT), including allogeneic HCT.
- Patients with known sensitivity to any of the ingredients of the Study Treatment.
- Patients who received radiation therapy within 14 days of the first dose of the Study Treatment.
- Patients who take drugs that prolong the QT interval or cause torsades de pointes or produce significant ventricular dysrhythmias.
- Patients that are unwilling or unable to comply with the procedures required in this protocol.
- Recipient of solid organ transplant.
- History of a cardiovascular illness including: congestive heart failure (New York Heart Association Grade III or IV); unstable angina or myocardial infarction within the previous 6 months; or symptomatic cardiac arrhythmia despite medical management. QT interval corrected by heart rate using Fridericia’s correction formula (QTcF) >450 ms in male or >470 ms in female, or congenital long QT syndrome.
- Uncontrolled hypertension, systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg.
- Patients with new, active, or progressive brain metastases or leptomeningeal disease, except when considered for a separate open label cohort for special population
- History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer, or bowel resection that affects absorption of orally administered drugs.
- Active, known, or suspected autoimmune disease, except for Type I diabetes mellitus, hypothyroidism requiring only hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy.
- Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United States
- Singapore
- Australia
- South Africa
- New Zealand
- Japan
- United Kingdom
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United States; Singapore; Australia; South Africa; New Zealand and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.