RecruitingPhase 2NCT03646617

Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma

A Randomized Phase 2 Trial of Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma

Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

54 participants

Start Date

Nov 27, 2018

Study Type

INTERVENTIONAL

Conditions

Metastatic Melanoma

Summary

The main purpose of this study is to determine the safety of combining ipilimumab and nivolumab with hypofractionated radiotherapy to a single tumor in patients with metastatic melanoma. Another purpose of this study is to determine the effect of ipilimumab, nivolumab and hypofractionated radiotherapy on the cancer as compared to ipilimumab and nivolumab.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding targeted radiation to one tumor site improves the effectiveness of immunotherapy drugs (ipilimumab and nivolumab) in patients with melanoma that has spread to other parts of the body. **You may be eligible if...** - You have been diagnosed with metastatic melanoma (melanoma that has spread beyond the skin) - You have at least two measurable tumor sites - One of your tumors is between 1 cm and 7 cm and is in a location that can receive focused radiation - You are in good enough health to receive combination immunotherapy **You may NOT be eligible if...** - You have melanoma of the eye (uveal/ocular melanoma) - You have active brain metastases that are untreated or causing symptoms - You are taking high-dose steroid medications - You have a serious autoimmune disease - You have had a prior organ transplant - You are pregnant or breastfeeding - You have poor heart or lung function - You have had another cancer in the past 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated Radiation Therapy (HFRT)

The dose of HFRT will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.

DRUGNivolumab

Nivolumab (1 mg/kg) will be administered as an IV infusion over 30 minutes, followed by ipilimumab (3 mg/kg) on the same day given as an IV infusion over 90 minutes. The two drugs will be given on day 1, then every 3 weeks for a total of four doses. After these 4 doses, the patient and investigator will decide to continue with nivolumab (240 mg) every 2 weeks or Nivolumab (480mg) every 4 weeks as monotherapy for up to one year as an IV infusion over 30 minutes.

DRUGIpilimumab