At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic melanoma
- ✓At least two measurable lesions including index lesion per RECIST v1.1
- ✓Index lesion 1-7 cm amenable to hypofractionated radiation therapy
- ✓Able to tolerate HFRT positioning requirements
- ✕CNS metastases requiring urgent local therapy; carcinomatous meningitis excluded
- ✕Concurrent enrollment in another clinical study unless observational/non-interventional or follow-up period
- ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy except adjuvant PD-1 blockade
- ✕Concurrent treatment with any anticancer agent including chemotherapy or immunotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase 2 Trial of Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Hypofractionated Radiation Therapy (HFRT), Nivolumab, and 1 other intervention for Metastatic Melanoma. Currently recruiting, targeting 54 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
The dose of HFRT will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.
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.
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.