Melanoma Clinical Trial

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

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.

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Full 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.

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Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT05077280

Recruitment Status:

Recruiting

Sponsor:

California Pacific Medical Center Research Institute

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There is 1 Location for this study

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California Pacific Medical Center Research Institute
San Francisco California, 94115, United States More Info
Madeline Decker
Contact
415-600-3613
[email protected]
Kevin B Kim, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT05077280

Recruitment Status:

Recruiting

Sponsor:


California Pacific Medical Center Research Institute

How clear is this clinincal trial information?

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