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

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: Uveal Melanoma
• Intervention / Treatment: Radiation: stereotactic body radiotherapy; Drug: Immunotherapy

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

• Study Contact: Name: Madeline Decker; Phone Number: 4156006000; Email: KimKB@sutterhealth.org

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Recruiting
      • California Pacific Medical Center Research Institute
      • Contact: Madeline Decker; Phone Number: 415-600-3613; Email: KimB@sutterhealth.org
      • Principal Investigator: Kevin B Kim, M.D.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	toxicity measured by CTAE graded 3-5 toxicities	5 years

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: metastatic
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• 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