Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03922880|
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Drug: ADI PEG20 Drug: Nivolumab Drug: Ipilimumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Combining Arginine Depletion and Checkpoint Inhibition in Uveal Melanomas|
|Actual Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
|Experimental: Advanced Uveal Melanoma||
Drug: ADI PEG20
ADI-PEG 20 will be administered at a dose of 36mg/m2 intramuscularly once a week.
Nivolumab 240mg + Ipilimumab 1mg/kg for up to 8 total doses of ipilimumab. One ipilimumab has completed, nivolumab 480mg will be given every 4 weeks.
Ipilimumab 1mg/kg with Nivolumab 240mg for up to 8 total doses of ipilimumab. The first four doses of ipilimumab will be scheduled once every 3 weeks. The 5th-8th doses of ipilimumab will be scheduled once every 6 weeks with nivoumab 240mg every 3 weeks.
- Safety as assessed by CTCAE version 5.0 [ Time Frame: Up to 3 years ]
- Objective Response Rate by RECIST 1.1 [ Time Frame: Up to 3 years ]
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): NCT03922880
|Contact: Alexander Shoushtari, MDemail@example.com|
|Contact: Jedd Wolchok, MD, PhDfirstname.lastname@example.org|
|United States, New York|
|Memorial Sloan - Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Alexander Shoushtari, MD 646-888-4161|
|Principal Investigator:||Alexander Shoushtari, MD||Memorial Sloan Kettering Cancer Center|