A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma

December 2, 2022 updated by: California Pacific Medical Center Research Institute

A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma

This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Opdualag (nivolumab 480mg and relatlimab 160mg) 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. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two 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

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center Research Institute
        • Contact:
        • Principal Investigator:
          • Kevin B Kim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Opdualag or relatlimab
  • Certain autoimmune diseases.
  • Previous liver embolization or radiation.
  • Use of systemic steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and tolerability of the therapy
Time Frame: 5 years
toxicity measured by CTAE graded 3-5 toxicities
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 5 years
iRECIST defined response rates
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 years
survival without progressive cancer
5 years
Overall survival
Time Frame: 5 years
survival
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Investigators

  • Study Chair: David R Minor, MD, California Pacific Med Center Research Inst.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021.072-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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