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New treatment option for Clinical Stage I Cutaneous Melanoma AJCC v8
Official title Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
ClinicalTrials.gov ID: NCT04697576
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clinical stage i cutaneous melanoma ajcc v8.
Also referred to as Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016.
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
- This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Males or females
- 18 to 99 years of age
- Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2)...
- At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
You likely can't join if
- Known allergy or intolerance to influenza vaccination
- people with condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone/equivalent) or other immunosuppressive...
- Active, known or suspected autoimmune disease
- Active brain metastasis or leptomeningeal metastasis
- Diagnostic biopsy of ocular or mucosal melanoma
- Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted
See the full eligibility criteria
- Males or females
- 18 to 99 years of age
- Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma
- At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)
- Hemoglobin (Hgb) \>= 8 g/dL (drawn at or not more than 30 days prior to the screening visit)
- Platelet count \>= 100 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) or =\< 5 x ULN in patients with liver metastases (Cohort 2 only) (drawn at or not more than 30 days prior to the...
- Prothrombin time =\< 1.5 x ULN (drawn at or not more than 30 days prior to the screening visit)
- Total bilirubin =\< 1.5 x ULN (unconjugated bilirubin of \< 3 x ULN for patients with known Gilbert syndrome) (drawn at or not more than 30 days prior to the screening visit)
- Creatinine clearance of \>= 50 ml/min by Cockcroft-Gault equation (drawn at or not more than 30 days prior to the screening visit)
- Women of childbearing potential (WOCBP) must agree to use effective contraceptive methods from screening until at least:
- Cohort 1: 14 days after the surgical resection for people in Cohort 1
- Cohort 2:
- Nivolumab: 5 months after the last dose of either nivolumab or intralesional Flucelvax, whichever is later
- Pembrolizumab: 4 months after the last dose of either pembrolizumab or intralesional Flucelvax, whichever is later
- Ipilimumab: 3 months after the last dose of either ipilimumab or intralesional Flucelvax, whichever is later
- Relatlimab + nivolumab (marketed under the trade name Opdualag): 5 months after the last dose of either Opdualag or intralesional Flucelvax, whichever is later.
- Combination ipilimumab with other checkpoint inhibitor: Whichever is later:
- 3 months after the last dose of either ipilimumab or intralesional Flucelvax
- Above-bulleted recommendation for nivolumab or pembrolizumab
- Non-childbearing potential is defined as a woman who meets either of the following criteria: a) postmenopausal state defined as no menses for 12 months without an alternative medical cause, or b) documented...
- Effective contraception methods are defined as one of the following:
- True abstinence, defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject
- Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception
- Condoms and spermicide
- Diaphragm and spermicide
- Oral or implanted hormonal contraceptive
- An intra-uterine device
- WOCBP must have a negative pregnancy test (serum or urine)
- Known allergy or intolerance to influenza vaccination
- people with condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
- Active, known or suspected autoimmune disease
- Active brain metastasis or leptomeningeal metastasis
- Diagnostic biopsy of ocular or mucosal melanoma
- Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted
- Incarcerated patients
- Patients known to be HIV positive are eligible if they meet the following criteria within 30 days prior to randomization: stable and adequate CD4 counts (≥ 350 mm\^3), and serum HIV viral load of \< 25,000 IU/ml...
- Pregnant or lactating patients
- Patients incapable of independently providing consent
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, 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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, 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.