Actively Recruiting
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-04-29
57
Participants Needed
1
Research Sites
709 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Willing and able to comply with study visits, treatments, and tests
- ECOG Performance Status of 0-1
- Histologically confirmed basal cell carcinoma considered unresectable or metastatic
- For Cohort A: treatment-naive patients with no prior hedgehog pathway inhibitors or T cell modulating agents
- For Cohort B: patients with disease progression on nivolumab plus relatlimab
- For Cohort C: patients with progression on anti-PD-1 treatment (on or off trial)
- At least one measurable lesion by RECIST 1.1 criteria
- Patients with Gorlin syndrome may enroll
- Male or female aged 18 years or older
- No prior T cell modulating agents for basal cell carcinoma
- Screening lab tests meeting specific blood counts and liver/kidney function criteria
- Women of childbearing potential must have negative pregnancy tests and agree to contraception
- Men sexually active with women of childbearing potential must agree to contraception
You will not qualify if you...
- Pregnant or nursing women
- Central nervous system metastases unless stable for at least 4 weeks and no steroid therapy needed
- Autoimmune disease or conditions requiring systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs unless approved by investigator
- HIV or AIDS
- Active hepatitis B or C infection
- Patients requiring antiviral therapy for hepatitis B
- Prior malignancy active within last 2 years unless approved by investigator
- Organ transplant recipients with functioning allograft
- For Cohorts B and C, previous severe toxicity to immunotherapy that makes restarting unsafe
- Elevated Troponin T or I above institutional limits without cardiologist clearance
- History of severe allergy or hypersensitivity to study drugs
- Severe toxicity to immune checkpoint blockers unless approved by investigator
- Prisoners or incarcerated individuals unless approved by investigator
- Participants detained for psychiatric or infectious disease treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
L
Lisa Kelemen, MSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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