Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Claire Verschraegen
Study ID
NCT03798639
Phase
PHASE1
Status
Completed

Conditions

  • Merkel Cell Carcinoma
  • Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Radiation Therapy — RADIATION
    Receive radiation therapy

Study Details

This phase I trial studies the side effects and how well nivolumab works when given together with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.

Key Dates

Start date
Jan 7, 2019
Status verified
Apr 2024
Primary completion
Dec 2, 2022
Completion
Dec 2, 2022

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (nivolumab, radiation therapy)
    Patients receive nivolumab IV over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (nivolumab, ipilimumab)
    Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of patients completing 12 months of treatment [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

Related Studies