Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver
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|ClinicalTrials.gov Identifier: NCT03472586|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eye and Orbit||Biological: Ipilimumab Biological: Nivolumab Drug: Embolization Therapy||Phase 2|
I. Determine the clinical benefit of treatment with immunoembolization (IEMBO) in combination with ipilimumab and nivolumab.
I. Determine all treatment and immune related toxicities. II. Determine progression free survival. III. Determine overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ipilimumab and Nivolumab in Combination With Immunoembolization for the Treatment of Metastatic Uveal Melanoma|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Treatment (ipilimumab, nivolumab, immunoembolization)
Participants receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Participants also undergo immunoembolization on day 2. Courses repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Participants with complete response, partial response, or stable disease may receive nivolumab IV over 30 minutes on day 1 and undergo immunoembolization on day 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Embolization Therapy
- Hepatic metastasis stabilization rate by response criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) [ Time Frame: At week 12 ]The estimate of the hepatic metastasis stabilization rate will be presented with corresponding 95% confidence intervals. The method of Atkinson and Brown will be used to adjust for the two-stage design.
- Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 1 year ]Toxicity rates will be estimated with corresponding 95% confidence intervals.
- Progression free survival (PFS) [ Time Frame: From the start of the treatment to confirmation of progression of disease, assessed up to 1 year ]Will be estimated using the Kaplan-Meier method.
- Overall survival [ Time Frame: From the start of the treatment to confirmation of progression of disease, assessed up to 1 year ]Will be estimated using the Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472586
|Contact: Marlana Orloff, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Marlana Orloff, MD 215-955-8874 email@example.com|
|Principal Investigator:||Marlana Orloff, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|