Actively Recruiting
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
90
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to participate voluntarily with signed informed consent
- 18 years of age or older
- Histologic diagnosis of melanoma (cutaneous, acral, mucosal, or unknown primary) at specified AJCC 8th edition stages
- No prior systemic therapy for melanoma for Part 1 and Part 2 Cohort A; refractory locoregionally advanced melanoma for Part 2 Cohort B
- Surgically operable melanoma confirmed by pathological diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function within 28 days before treatment
- Provide adequate tumor tissue sample within 90 days before consent or fresh biopsy if needed
- Evaluated by standard full body imaging as per physician's choice
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Male participants with female partners of childbearing potential must agree to use contraception
- Willing and able to comply with protocol requirements
You will not qualify if you...
- Pregnancy or lactation
- Treatment with investigational drugs or systemic melanoma therapies within 4 weeks prior to study drugs; radiotherapy within 2 weeks
- Less than 4 weeks recovery from major surgery or active infection
- Diagnosis of ocular or uveal melanoma
- Bowel obstruction within past 3 months
- Active significant cardiovascular disease within 6 months
- Active or history of brain or leptomeningeal metastases
- Concurrent malignancy requiring treatment or recent prior malignancy active within 2 years
- Recent cytotoxic or targeted therapy within 3 weeks or antibody therapy within 4 weeks
- Recent SARS-CoV-2 vaccine or booster less than 7 days before treatment
- Known allergy or hypersensitivity to study drugs
- Current or history of interstitial lung disease or pneumonitis requiring high-dose steroids
- History of allogeneic organ transplant
- Psychiatric or substance abuse disorders interfering with study compliance
- Use of systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressive meds within specified periods
- Active autoimmune disease requiring systemic treatment within 2 years
- Conditions or treatments that may interfere with participation or study results
- Previous SARS-CoV-2 infection within 10-20 days before treatment depending on severity
- Uncontrolled HIV infection; uncontrolled hepatitis B or active co-infections
- Dependence on total parenteral nutrition
- Elevated troponin levels above specified limits
- Left ventricular ejection fraction below 50%
- History or current myocarditis
- Allergy or hypersensitivity to study intervention components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
L
Lina Moreno
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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