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New treatment option for Melanoma Stage III
Official title Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
ClinicalTrials.gov ID: NCT06295159
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for melanoma stage iii.
Also referred to as Opdivo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- This study is divided into 2 sub-studies/parts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2. In...
- Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
- 18 years of age or older
- Histologic diagnosis of melanoma (cutaneous, acral, mucosal or unknown primary) belonging to the following American Joint Committee on Cancer (AJCC)...
- Requirements for prior systemic therapy for melanoma are as follows:
You likely can't join if
- Pregnancy or lactation.
- Treatment with another investigational drug or other systemic intervention for melanoma within 4 weeks of initiation of study drugs. Patients must...
- Participants must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable...
- Ocular or uveal melanoma.
- Bowel obstruction or impending bowel obstruction within the past 3 months.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of...
See the full eligibility criteria
Who can join
- This study is divided into 2 sub-studies/parts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2. In Part 2, Part 2 Cohort A and Part 2 Cohort B will enroll...
- Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
- 18 years of age or older
- Histologic diagnosis of melanoma (cutaneous, acral, mucosal or unknown primary) belonging to the following American Joint Committee on Cancer (AJCC) 8th edition TNM stages (Tx or T1-4) and (N1b, N1c, N2b, N2c, N3b or...
- Requirements for prior systemic therapy for melanoma are as follows:
- Sub-study Part 1: No prior systemic therapy for melanoma (N=30).
- Sub-study Part 2 Cohort A: No prior systemic therapy for melanoma (N=20)
- Sub-study Part 2 Cohort B: Locoregionally advanced melanoma that is refractory to systemic adjuvant therapy (anti-PD1-based or BRAF-MEK inhibitors) (N=40). This excludes patients who previously received adjuvant or...
- Must be considered surgically operable and may present as any of the following groups:
- Primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis.
- Clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis.
- Clinically or histologically detected primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis.
- Clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis.
- Participants with in-transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist.
- Participants with distant cutaneous/subcutaneous, soft tissue or nodal metastases with or without regional lymph node involvement are allowed if they are considered potentially surgically resectable and can be biopsied...
- Elevated LDH is not an exclusion.
- Participants are eligible for this study either at presentation for primary melanoma with concurrent regional nodal and/or in-transit or distant metastasis, or at the time of clinically detected nodal, in transit, or...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function within 28 days of Cycle 1 Day 1 (C1D1)
- Participants must provide a sufficient and adequate formalin-fixed paraffin-embedded (FFPE) tumor tissue sample from the most recent biopsy of a tumor lesion, obtained within 90 days from signing informed consent form...
- Participants must be evaluated by standard-of-care full body imaging studies, the choice of which is decided by the treating physician investigator.
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) in accordance with the standard of care for WOCBP.
- WOCBP must agree to use highly effective contraceptive measures starting with the screening visit through 5 months after the last dose of study treatment. Highly effective contraception is as stipulated in national or...
- Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 5 months after the last dose...
- Willing and able to comply with the requirements of the protocol.
What rules you out
- Pregnancy or lactation.
- Treatment with another investigational drug or other systemic intervention for melanoma within 4 weeks of initiation of study drugs. Patients must not have radiotherapy within the preceding 2 weeks. Patients must have...
- Participants must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable infection.
- Ocular or uveal melanoma.
- Bowel obstruction or impending bowel obstruction within the past 3 months.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure or serious uncontrolled...
- Active or history of brain metastases or leptomeningeal metastases.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment, i.e., patients with a history of prior malignancy are...
- Treatment with one of the following classes of drugs within the delineated time window prior to C1D1:
- Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.
- mAbs, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \ 7 days from C1D1 or \> 7 days from future cycle on study.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
- History of allogeneic organ transplant.
- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of...
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs.
- History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full...
- Pregnant or breastfeeding or WOCBP who are not willing to employ effective birth control from screening to 5 months after the last dose of study treatment (whichever is later).
- Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1.
- Uncontrolled infection with human Immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study...
- Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have...
- Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free...
- Dependence on total parenteral nutrition.
- Troponin T (TnT) or I (TnI) \> 2× institutional ULN. Participants with TnT or TnI levels between \> 1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between \>1 to...
- Left ventricular ejection fraction (LVEF) assessment with documented LVEF \< 50% by either transthoracic echocardiogram (TTE) or multigated acquisition (MUGA) scan (TTE preferred test) within 6 months prior to start of...
- Participants with a history of myocarditis and/or current diagnosis of myocarditis, regardless of etiology.
- Participants must not have a history of allergy or hypersensitivity to study intervention components.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. 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 ClinicalTrials.gov; the study team decides eligibility.