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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03521830
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 27, 2018
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2032

Study Design

Enrollment
57 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Previous Systemic Therapy Patients
    Cohort A: Nivolumab 480mg IV q4weeks for up to 48 weeks (six 8-week cycles)
  • Experimental: Progression after anti-PD-1 therapy (Cohort A) and Cohort C
    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.
  • Experimental: Progression after anti-PD-1 therapy (Cohort A)
    Cohort C: Nivolumab 480 mg IV q4 weeks plus relatlimab 480 mg IV q4 weeks for up to 48 weeks.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21231
Evan Lipson, MD
[email protected]
410-502-5977
Lisa Kelemen, MSN, RN
[email protected]
410-614-4618
Evan Lipson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Johns Hopkins Hospital· Baltimore, MD

Related Studies