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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma

Clinicaltrials.gov identifier NCT03922880

Recruitment Status Active, not recruiting

First Posted April 22, 2019

Last update posted January 10, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Uveal Melanoma
  • Intervention/Treatment: Drug: ADI PEG20
    Drug: Nivolumab
    Drug: Ipilimumab
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 9 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Pilot Study Combining Arginine Depletion and Checkpoint Inhibition in Uveal Melanomas
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Advanced Uveal Melanoma
Drug: ADI PEG20
ADI-PEG 20 will be administered at a dose of 36mg/m2 intramuscularly once a week.

Drug: Nivolumab
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.

Drug: Ipilimumab
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.
Outcome Measures
  • Primary Outcome Measures: 1. Safety as assessed by CTCAE version 5.0 [ Time Frame: Up to 3 years ]
  • Secondary Outcome Measures: 1. Objective Response Rate by RECIST 1.1 [ Time Frame: Up to 3 years ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 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)
of 0-1.

- 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:

http://tavarelab.cruk.com.ac.uk/JanowitzWilliamsGFR/

- 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

Exclusion Criteria:

- 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

Contacts and Locations
Contacts
Locations

United States, New York
Memorial Sloan - Kettering Cancer Center
New York

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Alexander Shoushtari, MD Memorial Sloan Kettering Cancer Center

More Information
  • Responsible Party: Memorial Sloan Kettering Cancer Center
  • ClinicalTrials.gov Identifier: NCT03922880 History of Changes
  • Other Study ID Numbers: 19-010
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: January 10, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Memorial Sloan Kettering Cancer Center: ADI-PEG 20
    nivolumab
    ipilimumab
    Memorial Sloan Kettering Cancer Center
    19-010
  • Additional relevant MeSH terms: Melanoma Uveal Neoplasms