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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01810016




Registration number
NCT01810016
Ethics application status
Date submitted
8/03/2013
Date registered
13/03/2013

Titles & IDs
Public title
NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma
Scientific title
Phase I Study of NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma, for Whom Treatment With Ipilimumab is Indicated
Secondary ID [1] 0 0
LUD2012-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable or Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ipilimumab
Treatment: Other - NY-ESO-1 Protein Vaccine
Treatment: Other - NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide
Treatment: Other - NY-ESO-1 OLP4 Vaccine with Poly-ICLC

Experimental: Arm A - Ipilimumab (IV) followed by NY-ESO-1 recombinant protein mixed with Poly-ICLC and Montanide (SC) every 3 weeks for 4 doses.

Experimental: Arm B - Ipilimumab (IV) followed by NY-ESO-1 OLP4 mixed with Poly-ICLC and Montanide (SC) every 3 weeks for 4 doses.

Experimental: Arm C - Ipilimumab (IV) followed by NY-ESO-1 OLP4 mixed with Poly-ICLC (SC) every 3 weeks for 4 doses.


Treatment: Other: Ipilimumab
Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.

Treatment: Other: NY-ESO-1 Protein Vaccine
NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.

Treatment: Other: NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide
NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.

Treatment: Other: NY-ESO-1 OLP4 Vaccine with Poly-ICLC
NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With Treatment-emergent Adverse Events
Timepoint [1] 0 0
Continuously for up to 6 months
Secondary outcome [1] 0 0
Number of Patients With Immune-related Tumor Response at the Last Assessment
Timepoint [1] 0 0
Up to 5 months

Eligibility
Key inclusion criteria
1. Patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab was indicated as per ipilimumab/Yervoy® package insert (applicable for United States [US] sites) or product information (applicable for Australia site).
2. Radiologically measurable disease by irRC.
3. Tumor expression of NY-ESO-1 or LAGE-1 antigen by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR), or evidence of seropositivity to NY-ESO-1 or LAGE-1.
4. Willingness to provide at least one pre-and post-vaccination tumor biopsy sample.
5. Expected survival of at least 4 months.
6. At the time of Day 1 of the study, patients must have been at least 3 weeks since surgery.
7. At the time of Day 1 of the study, patients with brain metastases must have been asymptomatic and:

* at least 8 weeks without tumor progression after any whole brain radiotherapy;
* at least 4 weeks since craniotomy and resection or stereotactic radiosurgery;
* at least 3 weeks without new brain metastases as evidenced by magnetic resonance imaging (MRI).
8. Eastern Cooperative Oncology Group performance status of 0 to 2.
9. Laboratory parameters for vital functions must have been in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which must have been within the ranges specified:

* hemoglobin: = 10 g/dL;
* neutrophil count: = 1.5 x 10^9/L;
* lymphocyte count: = lower limit of normal (LLN);
* platelet count: = 80 x 10^9/L;
* serum creatinine: = 2 mg/dL;
* serum bilirubin: = 2 x upper limit of normal (ULN);
* aspartate aminotransferase (AST)/alanine aminotransferase (ALT): = 2 x ULN.
10. Had been informed of other treatment options.
11. Age = 18 years.
12. Able and willing to give valid written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any contraindications for ipilimumab/Yervoy® as per package insert (applicable for US sites) or product information (applicable for Australia site).
2. Prior exposure to NY-ESO-1 vaccine.
3. Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (e.g., +antinuclear antibody [ANA], +rheumatoid factor [RF], antithyroglobulin antibodies), or mild arthritis requiring no therapy or manageable with nonsteroidal anti-inflammatory drugs (NSAIDs).
4. Unresolved immune-related adverse events following prior biological therapy.
5. Systemic treatment with high-dose corticosteroids (greater than prednisone 10 mg daily or equivalent).
6. Treatment with protocol-specified non-permitted concomitant therapies.
7. Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may have been available.
8. Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor.
9. Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
10. Known immunodeficiency or human immunodeficiency virus positivity, active Hepatitis B or active Hepatitis C.
11. History of severe allergic reactions to vaccines or unknown allergens.
12. Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
13. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to Day 1 of the study.
14. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
15. Lack of availability for immunological and clinical follow-up assessments.
16. Women who were breast feeding or pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) done within 14 days prior to first dosing and urine test within 72 hours prior to first dosing.
17. Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
18. Any condition that, in the clinical judgment of the treating physician, was likely to prevent the patient from complying with any aspect of the protocol or that may have put the patient at unacceptable risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2016
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health, Ludwig Oncology Unit - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Other
Name
Ludwig Institute for Cancer Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Research Institute, NY, USA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael A Postow, MD
Address 0 0
Memorial Sloan Kettering Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01810016