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Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03922880
Recruitment Status Active, not recruiting
First Posted April 22, 2019
Last update posted January 10, 2020
This study is measuring the safety of the study drug, ADI-PEG 20, combined with immunotherapy drugs nivolumab and ipilimumab in treating patients with advanced uveal melanoma.
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Advanced or unresectable melanoma of presumed uveal origin. Non-uveal melanomas with
"malignant blue nevus" physiology with GNAQ, GNA11, CYSLTR2, or PLCB4 driver
alterations are eligible upon discussion with the Principal Investigator.
- Disease must be measurable according to RECIST 1.1. Disease that has undergone local
therapy in the past 30 days is not considered measurable unless the investigator has
documented progression despite the local therapy.
- Disease must be amenable to a biopsy attempt, in the opinion of the investigator.
- Asymptomatic untreated brain metastases are allowed. Symptomatic brain metastases that
have undergone local therapy with RT or surgery and have not required an increase in
steroid dose in prior 2 weeks are allowed.
Note: Seizure prophylaxis with untreated brain metastases are allowed.
- Patients must have an Easter Cooperative Oncology Group (ECOG) Performance Statue (PS)
- Acceptable liver, renal, and hematological function:
- Total bilirubin </= 1.5x upper limit of normal (ULN); patients with Gilbert's Syndrome
must have bilirubin </= 3x ULN
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) </= 3 x
ULN (/= 30 mL/min using a cancer-specific GFR
Model; the calculator found at:
- Hemoglobin >/= 9 g/dL
- Neutrophils >/= 1.5 x 10^9/L
- Platelets >/= 100 x 10^9/L
- Female patients of childbearing potential and their partners (if male) and male
patients with female partners of childbearing potential and their partners must agree
to use a highly effective form of contraception for the duration of the study from the
list below or agree to refrain from intercourse for the duration of the trial and for
at least 30 days after the last administration of ADI-PEG20 and at least 150 days (if
female) or 210 days (if male) after the final dose of ipilimumab and/or nivolumab
whichever is later. Highly effective forms of contraception include the following:
- combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal or transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, implantable)
- intrauterine device
- intrauterine hormone-releasing system
- bilateral tubal occlusion
- vasectomized partner
- Other active malignancy that in the opinion of the treating investigator will
interfere with the assessments of efficacy for uveal melanoma in this study
- History of seizure disorder not related to malignancy
- Pregnancy or lactation
- Expected non-adherence to protocol
- Known allergy to E. coli drug products (such as GM-CSF)
- Known allergy to pegylated compounds
- Prior treatment with ADI-PEG20 or another experimental arginine deprivation strategy
- Systemic anticancer therapy within 3 weeks or 1 cycle length, whichever is shorter, of
first day of planned study therapy
- Presence of treatment-related adverse events that have not recovered or stabilized at
Grade 1 (excepting vitiligo and alopecia or treated endocrine conditions). AEs that
are Grade 2 that are not felt to be a significant safety risk (e.g. rash, asymptomatic
thyroiditis) may be allowable upon discussion with the Principal Investigator.
- Active autoimmune disease or any condition requiring greater than 10mg prednisone per
day equivalent or other immune suppressive medication (e.g. anti-TNF agents) within 14
days of study screening. Inhaled or topical steroids and adrenal replacements does of
steroids >10mg prednisone are allowed in the absence of active autoimmune disease.
- History of myocarditis or motor neuropathy of any grade
- Gout flares within the past 28 days or sequelae of chronic gout, such as gouty
arthritis, are excluded.
Note: Patients with asymptomatic hyperuricemia without arthralgias or arthritic symptoms
are eligible, as are patients with known gout on chronic uric acid lowering medication who
have not experienced a flare within 28 days
United States, New York
Memorial Sloan - Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Principal Investigator: Alexander Shoushtari, MD Memorial Sloan Kettering Cancer Center