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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 Opdualag or relatlimab.
  • - Certain autoimmune diseases.
  • - Previous liver embolization or radiation.
- Use of systemic steroids

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05077280
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 California Pacific Medical Center Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David R Minor, MD
Principal Investigator Affiliation California Pacific Med Center Research Inst.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Uveal Melanoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: one arm

see below

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Recruiting

Address

California Pacific Medical Center Research Institute

San Francisco, California, 94115

Site Contact

Madeline Decker

[email protected]

415-600-3613

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