CompletedPhase 1

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

United States7 participantsStarted 2019-01-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Be willing and able to understand and give written informed consent and comply with all study related procedures * All patients should undergo definitive surgical resection, including when possible sentinel lymph node dissection * Patients must have recovered after any recent surgery and be ambulatory * Have node positive disease (stage pIIIA or pIIIB) +/- extracapsular extension * Have node negative disease and any of the following high risk features * Tumor size \>= 2 cm * Margins =\< 1-2 cm and re-resection is not possible * Evidence of perineural or lymphovascular invasion * Human immunodeficiency virus (HIV) patients with undetectable viral load and CD4+ T-cell counts \>= 350 cells/uL * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mcL (performed within 16 days of treatment initiation) * Platelets \>= 100,000/mcL in the absence of transfusion support within 7 days of determining eligibility (performed within 16 days of treatment initiation) * Hemoglobin \>= 8 g/dL (performed within 16 days of treatment initiation) * Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance \>= 40 mL/min creatinine clearance (performed within 16 days of treatment initiation) (Glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) * Creatinine clearance should be calculated per institutional stan…

What they're measuring

Percentage of patients completing 12 months of treatment

Timeframe: Up to 12 months

Trial details

NCT IDNCT03798639

SponsorClaire Verschraegen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-02