A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma

Sponsor

California Pacific Medical Center Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05077280

Collaborator

(none)

Enrollment

Location

Arm

53.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma	Radiation: stereotactic body radiotherapy Drug: Immunotherapy	Phase 2

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 ipilimumab and nivolumab 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. 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. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 20, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

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 Ipilimumab 1mg/kg every 6 weeks for 12 doses & nivolumab 360mg every 3 weeks for 2-3 years

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

Ipilimumab 1mg/kg every 6 weeks for 12 doses & nivolumab 360mg every 3 weeks for 2-3 years

Outcome Measures

Primary Outcome Measures

safety and tolerability of the therapy [5 years]
toxicity measured by CTAE graded 3-5 toxicities

Secondary Outcome Measures

Response rate [5 years]
iRECIST defined response rates

Other Outcome Measures

Progression-free survival [5 years]
survival without progressive cancer
Overall survival [5 years]
survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ipilimumab or other CTLA-4 inhibitor.
Certain autoimmune diseases.
Previous liver embolization or radiation.
Use of systemic steroids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Pacific Medical Center Research Institute	San Francisco	California	United States	94115

Sponsors and Collaborators

California Pacific Medical Center Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

California Pacific Medical Center Research Institute

ClinicalTrials.gov Identifier:

NCT05077280

Other Study ID Numbers:

2021.072-2

First Posted:

Oct 14, 2021

Last Update Posted:

Oct 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by California Pacific Medical Center Research Institute

metastatic

Additional relevant MeSH terms:

Melanoma

Uveal Neoplasms

Study Results

No Results Posted as of Oct 21, 2021