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

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ClinicalTrials.gov Identifier: NCT05077280
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
California Pacific Medical Center Research Institute

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.

Condition or disease Intervention/treatment Phase
Uveal Melanoma Radiation: stereotactic body radiotherapy Drug: Immunotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Ipilimumab and Nivolumab in Patients With Metastatic Uveal Melanoma
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2026


Arm Intervention/treatment
Experimental: one arm
see below
Radiation: stereotactic body radiotherapy
Stereotactic Body radiotherapy will be given to 1-5 target metastases in 3 doses over 8 days or less. Each dose will be 15Gy for a total dose of 45GY

Drug: Immunotherapy
Ipilimumab 1mg/kg every 6 weeks for 12 doses & nivolumab 360mg every 3 weeks for 2-3 years




Primary Outcome Measures :
  1. safety and tolerability of the therapy [ Time Frame: 5 years ]
    toxicity measured by CTAE graded 3-5 toxicities


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 5 years ]
    iRECIST defined response rates


Other Outcome Measures:
  1. Progression-free survival [ Time Frame: 5 years ]
    survival without progressive cancer

  2. Overall survival [ Time Frame: 5 years ]
    survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05077280


Contacts
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Contact: Madeline Decker 4156006000 KimKB@sutterhealth.org

Locations
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United States, California
California Pacific Medical Center Research Institute Recruiting
San Francisco, California, United States, 94115
Contact: Madeline Decker    415-600-3613    KimB@sutterhealth.org   
Principal Investigator: Kevin B Kim, M.D.         
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
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Study Chair: David R Minor, MD California Pacific Med Center Research Inst.
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Responsible Party: California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT05077280    
Other Study ID Numbers: 2021.072-2
First Posted: October 14, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by California Pacific Medical Center Research Institute:
metastatic
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases