Actively Recruiting
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-08-13
54
Participants Needed
3
Research Sites
474 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic melanoma
- At least two measurable lesions including one between 1 cm and 7 cm suitable for hypofractionated radiation therapy
- Able to tolerate hypofractionated radiation therapy positioning
- Age over 18 years and able to provide written informed consent
- ECOG performance status of 0 or 1
- Recovery from prior cancer treatment side effects to Grade 1 or better except alopecia
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before treatment
- Female participants of childbearing potential must use two methods of birth control or abstain from heterosexual activity before and during study treatment, continuing 120 days after last dose
- Non-sterilized male participants must use adequate contraception during study treatment and for 120 days after last dose
- Adequate organ function based on recent laboratory tests
- White blood cell count ≥ 2,500 cells/µL
- Absolute neutrophil count ≥ 1,500 cells/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 times upper limit normal or creatinine clearance ≥ 60 mL/min
- Serum total bilirubin ≤ 1.5 times upper limit normal or direct bilirubin ≤ upper limit normal if total bilirubin is higher
- AST and ALT ≤ 2.5 times upper limit normal or ≤ 5 times upper limit normal if liver metastases present
You will not qualify if you...
- Central nervous system metastases requiring urgent treatment or carcinomatous meningitis
- Participation in another clinical trial unless observational or follow-up
- Prior therapy with anti-PD-1, anti-PD-L1, anti-CTLA4, interferon, HD IL-2, or other T-cell targeting drugs except prior adjuvant PD-1 blockade
- Concurrent anticancer therapy including chemotherapy, immunotherapy, or biologics
- Treatment with investigational agents within 4 weeks before study
- Recent chemotherapy or targeted therapy within 2 weeks or unresolved adverse effects except Grade ≤ 2 neuropathy
- Known allergy to nivolumab, ipilimumab, monoclonal antibodies, or immunoglobulin G
- Major surgery within 28 days or incomplete recovery from prior surgery
- Immunosuppressive medication use within 14 days except certain corticosteroids
- Active or recent autoimmune disease within 1 year except some stable or mild conditions
- History of primary immunodeficiency or tuberculosis
- Known HIV, active Hepatitis B or C infection
- Live vaccine within 28 days before treatment or planned during study and 180 days after
- Contraindications to hypofractionated radiation
- Prior radiotherapy preventing current hypofractionated radiation or within 28 days
- Pregnancy, lactation, or intention to become pregnant during study
- Uncontrolled illness or conditions affecting study compliance
- Other active invasive cancers except certain treated or non-invasive malignancies
- Any condition interfering with treatment evaluation or safety interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
2
Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
T
Tara Mitchell, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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