Brief Title
A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma
Official Title
A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Ipilimumab and Nivolumab in Patients With Metastatic Uveal Melanoma
Brief Summary
This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with
immunotherapy with ipilimumab and nivolumab for up to two years. SBRT will be given in three
doses of 15Gy each to 1-5 separate metastases. Ipilimumab will be given at 1mg/kg q 6 weeks
for 12 doses, and nivolumab will be given 360mg every 3 weeks for 2-3 years.
Detailed Description
Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation
therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of
concurrent stereotactic radiation therapy (SBRT) with immunotherapy with ipilimumab and
nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate
metastases, limiting the total dosage to 700cc's of normal liver to <15Gy. Ipilimumab will be
given at 1mg/kg q 6 weeks for 12 doses, and nivolumab will be given 360mg every 3 weeks for
2-3 years. Objectives are to determine the safety and tolerability, and iRECIST will be used
to determine responses.We will treat up to 50 patients.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
safety and tolerability of the therapy
Secondary Outcome
Response rate
Condition
Uveal Melanoma
Intervention
stereotactic body radiotherapy
Study Arms / Comparison Groups
one arm
Description: see below
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
40
Start Date
September 20, 2021
Completion Date
March 2026
Primary Completion Date
March 2024
Eligibility Criteria
Inclusion Criteria:
- measurable metastatic uveal melanoma.
- No concomitant therapy.
- Prior PD1 or tebendafesp allowed.
- Performance status 0-1.
- No active Hepatitis B.
- No known HIV infection.
- WBC>2000, ANC>1500, Hgb >8.
- Creatinine < 3 x ULN.
- AST & ALT < 2.5 x ULN Bilirubin < 2 x ULN.
- Albumin >2.9
Exclusion Criteria:
- Liver tumor volume > 50%.
- Active CNS metastases.
- Pregnancy.
- Prior therapy with ipilimumab or other CTLA-4 inhibitor.
- Certain autoimmune diseases.
- Previous liver embolization or radiation.
- Use of systemic steroids
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
David R Minor, MD, 4156006000, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05077280
Organization ID
2021.072-2
Responsible Party
Sponsor
Study Sponsor
California Pacific Medical Center Research Institute
Study Sponsor
David R Minor, MD, Study Chair, California Pacific Med Center Research Inst.
Verification Date
September 2021