Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 5, 2021
First Posted Date  ICMJE October 14, 2021
Last Update Posted Date October 21, 2021
Actual Study Start Date  ICMJE September 20, 2021
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2021)
safety and tolerability of the therapy [ Time Frame: 5 years ]
toxicity measured by CTAE graded 3-5 toxicities
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2021)
Response rate [ Time Frame: 5 years ]
iRECIST defined response rates
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 5, 2021)
  • Progression-free survival [ Time Frame: 5 years ]
    survival without progressive cancer
  • Overall survival [ Time Frame: 5 years ]
    survival
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uveal Melanoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: one arm
see below
Interventions:
  • Radiation: stereotactic body radiotherapy
  • Drug: Immunotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Madeline Decker 4156006000 KimKB@sutterhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05077280
Other Study ID Numbers  ICMJE 2021.072-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party California Pacific Medical Center Research Institute
Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: David R Minor, MD California Pacific Med Center Research Inst.
PRS Account California Pacific Medical Center Research Institute
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP