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New treatment option for Basal Cell Carcinoma
Official title Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT03521830
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for basal cell carcinoma.
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
- This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with relatlimab or ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell carcinoma.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 weeks
- Which group you join is decided by chance.
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
- Signed Written Informed Consent
- people must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and...
- people must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
- Type of Participant and Target Disease Characteristics
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
You likely can't join if
- Medical Conditions
- Pregnant or nursing women
- Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.
- Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone...
- Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Viral hepatitis. i. Participants with active hepatitis B (positive hepatitis B surface antigen [HBsAg] or hepatitis C virus (HCV) (positive HCV RNA)...
See the full eligibility criteria
- Signed Written Informed Consent
- people must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of...
- people must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
- Type of Participant and Target Disease Characteristics
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic. i) COHORT A: Patients with advanced BCC who are treatment-naïve...
- Laboratory Testing Requirements Screening laboratory values obtained within -28 +/- 3 days of first dose must meet the following criteria:
- White Blood Cells greater than or equal to 2000/μL
- Neutrophils greater than or equal to 1500/μL
- Platelets greater than or equal to 100 x 10³/μL
- Hemoglobin greater than or equal to 9.0 g/dL
- Serum creatinine less than or equal to 1.5 x Upper Limit of Normal (ULN)or creatinine clearance (CrCl) greater than or equal to 40 mL/minute (using Cockcroft/Gault formula)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN, except in patients with liver metastases whose values may be less than or equal to 5 x ULN
- Total Bilirubin less than or equal to 1.5 x ULN (except people with Gilbert Syndrome who may have total bilirubin less than or equal to 3.0 mg/dL)
- Reproductive Status
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the initial administration of study drug, then...
- Women must not be breastfeeding.
- WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 30 days (duration...
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 90 days...
- Azoospermic males and those who are continuously not heterosexually active are exempt from contraceptive requirements.
- WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, however they must still undergo pregnancy testing as described in this section.
- Medical Conditions
- Pregnant or nursing women
- Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.
- Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications may be permitted to enroll...
- Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Viral hepatitis. i. Participants with active hepatitis B (positive hepatitis B surface antigen [HBsAg] or hepatitis C virus (HCV) (positive HCV RNA) are excluded. ii. Patients with past Hepatitis B virus (HBV) infection...
- Allergies and Adverse Drug Reaction
- History of severe allergy or hypersensitivity to study drug components.
- Patients with a history of a severe toxicity to an immune checkpoint blocking drug may be permitted to enroll only after discussion with the study P.I.
- Other Exclusion Criteria
- Prisoners or participants who are incarcerated may be permitted to enroll only after discussion with the study P.I.
- Participants who are detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, 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 48 weeks 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, 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.