A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma

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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