Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

NCT03521830 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: J1866IRB00166274CA209-8DP
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response rate per the revised Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  5 years

Secondary Outcomes (3)

• progression-free survival

  5 years

• duration of response

  5 years

• overall survival

  5 years

Study Arms (3)

Previous Systemic Therapy Patients

ACTIVE COMPARATOR

Cohort A: Nivolumab 480mg IV q4weeks for up to 48 weeks (six 8-week cycles)

Drug: Nivolumab

Progression after anti-PD-1 therapy (Cohort A) and Cohort C

EXPERIMENTAL

Cohort B: Nivolumab 240mg IV + ipilimumab 1mg/kg IV q3 weeks x 4 doses, then nivolumab 480mg IV q4 weeks x 7 doses for up to 48 total weeks of therapy.

Drug: Nivolumab; Drug: Ipilimumab

Progression after anti-PD-1 therapy (Cohort A)

EXPERIMENTAL

Cohort C: Nivolumab 480 mg IV q4 weeks plus relatlimab 480 mg IV q4 weeks for up to 48 weeks.

Drug: Nivolumab; Drug: Relatlimab

Interventions

Nivolumab DRUG

480mg IV every 4 weeks

Also known as: Opdivo

Previous Systemic Therapy Patients; Progression after anti-PD-1 therapy (Cohort A); Progression after anti-PD-1 therapy (Cohort A) and Cohort C

Ipilimumab DRUG

1mg/kg IV every 4 weeks for 4 doses

Also known as: Yervoy

Progression after anti-PD-1 therapy (Cohort A) and Cohort C

Relatlimab DRUG

480 mg IV q4wks

Progression after anti-PD-1 therapy (Cohort A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Written Informed Consent
• Subjects 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 any protocol related procedures that are not part of normal subject care.
• Subjects 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 (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (nivolumab) alone.
• ii) COHORT B: • Patients with advanced BCC who experience disease progression on anti-PD-1 (nivolumab) + anti-LAG-3 (relatlimab) will receive anti-PD-1 (nivolumab) + anti-CTLA-4 (ipilimumab).
• iii) COHORT C: • Patients with advanced BCC who experience disease progression on anti-PD-1 (on or off trial) will receive anti-PD-1 (nivolumab) + anti-LAG-3 (relatlimab).
• c. At least one measurable lesion by the RECIST 1.1 Criteria.
• d. Participants with Gorlin syndrome will be permitted to enroll in the study.
• e. Male or female, aged 18 years or older.
• f. Patients may not have received prior T cell modulating agents for BCC (e.g., anti-CTLA-4, anti-PD-L1, anti-LAG-3, anti-KIR, etc.)
• Laboratory Testing Requirements
• Screening laboratory values obtained within -28 +/- 3 days of first dose must meet the following criteria:

You may not qualify 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 equivalent) or other immunosuppressive medications may be permitted to enroll only after discussion with the study P.I.
• 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 or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and the absence of HBsAg) are not ineligible, but HBV DNA quantification must be performed and results discussed with the P.I.
• iii. HBV carriers or those participants requiring antiviral therapy are not eligible to participate.
• iv. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA after discussion with the study P.I.
• f. Participants with a prior malignancy active within the previous 2 years may be permitted to enroll only after discussion with the study P.I. Examples might include locally curable cancers that have been apparently cured, such as squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
• g. Organ transplant recipients with a functioning allograft will be excluded from this study.
• h. For Cohorts B and C, patients may be excluded from the study if they previously experienced a toxicity to immunotherapy that, in the opinion of the investigator, would make it unsafe to restart therapy. Examples may include a Grade 3 or greater immune mediated adverse event that was considered related to previous immunotherapy and required immunosuppressive therapy, or an immune mediated adverse event that was considered related to previous immunotherapy and is still \> grade 1 despite administration of immunosuppressive therapy. Exceptions may include Grade 3 ophthalmologic immune-mediated events that improved to Grade 1 within 2 weeks after topical therapy only, or Grade 3 endocrine immune-mediated events that did not result in symptoms lasting \>6 weeks and are not requiring \>7.5mg prednisone or equivalent per day.
• i) For Cohort C, Troponin T (TnT) or I (TnI) \> 2 × institutional ULN. Participants with TnT or TnI levels between \> 1 to 2 × ULN will be permitted if a repeat levels within 24 hours are ≤ 1 ULN. If TnT or TnI levels are between \>1 to 2 × ULN within 24 hours, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. When repeat levels within 24 hours are not available, a repeat test will be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \< 2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation.
• Allergies and Adverse Drug Reaction

Sponsors & Collaborators

• Bristol-Myers Squibb: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Nivolumab; Ipilimumab; relatlimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Evan J Lipson, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Kelemen, MSN, RN

CONTACT

410-614-4618; lkeleme1@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients from Arm A can crossover to Arm B or Arm C

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: November 27, 2018
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2032
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)