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

PHASE2RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 27, 2018

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2027

Conditions
Metastatic Melanoma
Interventions
RADIATION

Hypofractionated Radiation Therapy (HFRT)

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

DRUG

Nivolumab

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.

DRUG

Ipilimumab

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.

Trial Locations (3)

17601

RECRUITING

Lancaster General Hospital, Lancaster

19104

RECRUITING

Abramson Cancer Center, Philadelphia

84112

RECRUITING

Huntsman Cancer Institute at the University of Utah, Salt Lake City

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Abramson Cancer Center at Penn Medicine

OTHER