NCT05077280

Brief Summary

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

October 5, 2021

Last Update Submit

December 2, 2022

Conditions

Uveal Melanoma

Keywords

metastatic

Outcome Measures

Primary Outcomes (1)

  • safety and tolerability of the therapy

    toxicity measured by CTAE graded 3-5 toxicities

    5 years

Secondary Outcomes (1)

  • Response rate

    5 years

Other Outcomes (2)

  • Progression-free survival

    5 years

  • Overall survival

    5 years

Study Arms (1)

one arm

EXPERIMENTAL

see below

Radiation: stereotactic body radiotherapyDrug: Immunotherapy

Interventions

stereotactic body radiotherapyRADIATION

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

one arm
ImmunotherapyDRUG

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

one arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Uveal MelanomaNeoplasm Metastasis

Interventions

RadiosurgeryImmunotherapy

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesImmunomodulationBiological Therapy

Study Officials

  • David R Minor, MD

    California Pacific Med Center Research Inst.

    STUDY CHAIR

Central Study Contacts

Madeline Decker

CONTACT

4156006000KimKB@sutterhealth.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 14, 2021

Study Start

September 20, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2026

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)