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

Part of paid clinical trials in Lancaster, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT03646617
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Hypofractionated Radiation Therapy (HFRT) — RADIATION
    The dose of HFRT will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.
  • Nivolumab — DRUG
    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.
  • Ipilimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 27, 2018
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: No HFRT
    ipilimumab and nivolumab once every 3 weeks for up to 4 doses, followed by nivolumab once every 2 weeks or every 4 weeks until disease progression.
  • Experimental: HFRT
    The dose of hypofractionated radiation therapy (HFRT) will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.

Primary Outcome Measure

Number of Adverse Events [ Time Frame: 3.5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lancaster General HospitalLancasterPennsylvania17601
Krista Budzik, BSN, RN, OCN
[email protected]
717-544-0511
Shanthi Sivendran, MD
[email protected]
717-544-0511
Shanthi Sivendran, MD (PRINCIPAL_INVESTIGATOR)
Abramson Cancer CenterPhiladelphiaPennsylvania19104
Tara Mitchell, MD
[email protected]
855-216-0098
Tara Mitchell, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112
Kaitlin Stephens, MBA
[email protected]
801-213-8494

Find similar trials in Lancaster, PA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Lancaster General Hospital· Lancaster, PAAbramson Cancer Center· Philadelphia, PAHuntsman Cancer Institute at the University of Utah· Salt Lake City, UT

Related Studies