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NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Ludwig Institute for Cancer Research
Sponsor:
Collaborator:
Cancer Research Institute
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT01810016
First received: March 8, 2013
Last updated: August 26, 2013
Last verified: August 2013

March 8, 2013
August 26, 2013
March 2013
November 2014   (final data collection date for primary outcome measure)
  • Safety and tolerability according to the National Cancer Institute CTCAE v4.0 [ Time Frame: Up to Week 20 (+/-1) ] [ Designated as safety issue: Yes ]
    Number of adverse events
  • Immune Response [ Time Frame: Up to Week 20 (+/- 1) ] [ Designated as safety issue: No ]
    Induction or augmentation of NY-ESO-1 specific immunity will be determined.
Same as current
Complete list of historical versions of study NCT01810016 on ClinicalTrials.gov Archive Site
  • Tumor Response by the immune-related Response Criteria (irRC) [ Time Frame: Baseline, Week 13 and Week 20 (+/- 1) ] [ Designated as safety issue: No ]
    Tumor Response is defined as irCR, irPR or irSD over a period of at least 4 weeks as published by Wolchok et al.
  • Tumor Microenvironment [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
    Immunologic changes in the tumor microenvironment will be evaluated including patterns and extent of immune cell infiltrates, changes in chemokines and expression.
Same as current
Not Provided
Not Provided
 
NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma
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.

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Ipilimumab i.v. followed by NY-ESO-1 Protein vaccine with Poly-ICLC and Montanide s.c. (Arm A), or NY-ESO-1 OLP4 vaccine with Poly-ICLC and Montanide s.c. (Arm B), or NY-ESO-1 OLP4 vaccine mixed with Poly-ICLC without Montanide s.c.(Arm C).

This is a phase I, open-label, non-randomized study in 27 patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated. Patients must have evidence of NY-ESO-1 or LAGE-1 tumor positivity, radiologically measurable disease by immune-related Response Criteria (irRC), and meet all other eligibility criteria.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unresectable or Metastatic Melanoma
  • Biological: Ipilimumab
    Other Name: Yervoy
  • Biological: NY-ESO-1 Protein Vaccine
  • Biological: NY-ESO-1 OLP4 Vaccine
  • Experimental: Ipilimumab plus NY-ESO-1 OLP4 Vaccine with Montanide
    Ipilimumab i.v. over 90 minutes followed by NY-ESO-1 OLP4 mixed with Poly-ICLC and Montanide ISA 51 VG s.c. every 3 weeks for 4 doses.
    Interventions:
    • Biological: Ipilimumab
    • Biological: NY-ESO-1 OLP4 Vaccine
  • Experimental: Ipilimumab plus NY-ESO-1 Protein Vaccine with Montanide
    Ipilimumab i.v. over 90 minutes followed by NY-ESO-1 Protein mixed with Poly-ICLC and Montanide ISA 51 VG s.c. every 3 weeks for 4 doses.
    Interventions:
    • Biological: Ipilimumab
    • Biological: NY-ESO-1 Protein Vaccine
  • Experimental: Ipilimumab plus NY-ESO-1 OLP4 Vaccine without Montanide
    Ipilimumab i.v. over 90 minutes followed by NY-ESO-1 OLP4 mixed with Poly-ICLC s.c. every 3 weeks for 4 doses.
    Interventions:
    • Biological: Ipilimumab
    • Biological: NY-ESO-1 OLP4 Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
27
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated as per ipilimumab/Yervoy® package insert (applicable for US sites) or product information (applicable for Australia site).
  • Radiologically measurable disease by immune-related Response Criteria (irRC).
  • Tumor expression of NY-ESO-1 or LAGE-1 antigen by IHC or RT-PCR, or evidence of seropositivity to NY-ESO-1 or LAGE-1.
  • Willingness to provide at least one pre-and post-vaccination tumor biopsy sample.
  • Expected survival of at least 4 months.
  • At the time of day 1 of the study, patients must be at least 3 weeks since surgery.
  • At the time of day 1 of the study, patients with brain metastases must be asymptomatic and: 1) at least 8 weeks without tumor progression after any whole brain radiotherapy, 2) at least 4 weeks since craniotomy and resection or stereotactic radiosurgery, 3) at least 3 weeks without new brain metastases as evidenced by MRI
  • ECOG performance status of 0-2.
  • The following laboratory parameters must be within the ranges specified: Hemoglobin ≥ 10 g/dL, Neutrophil count ≥ 1.5 x 109/L, Lymphocyte count ≥ LLN Platelet count ≥ 80 x 109/L, Serum creatinine ≤ 2 mg/dL, Serum bilirubin ≤ 2 x ULN, AST/ALT ≤ 2 x ULN.
  • Have been informed of other treatment options.
  • Age ≥ 18 years.
  • Able and willing to give valid written informed consent.

Exclusion Criteria:

  • Any contraindications for ipilimumab/Yervoy® as per package insert(applicable for US sites) or product information (applicable for Australia site).
  • Prior exposure to NY-ESO-1 vaccine.
  • Active autoimmune disease, symptoms or conditions except for vitiligo, type I diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (e.g.: +ANA, +RF, antithyroglobulin antibodies), or mild arthritis requiring no therapy or manageable with NSAIDs.
  • Unresolved immune related adverse events following prior biological therapy.
  • Systemic treatment with high dose corticosteroids (greater than Prednisone 10mg daily or equivalent).
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
  • 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.
  • Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
  • Known immunodeficiency or HIV positivity, active Hepatitis B or active Hepatitis C.
  • History of severe allergic reactions to vaccines or unknown allergens.
  • Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to day 1 of the study.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Women who are breast feeding or pregnant as evidenced by pregnancy test.
  • Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
  • Any condition that, in the clinical judgment of the treating physician, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.
Both
18 Years and older
No
Contact: Jessica D Jensen, MPH 212-450-1574 jjensen@licr.org
United States,   Australia
 
NCT01810016
LUD2012-004
No
Ludwig Institute for Cancer Research
Ludwig Institute for Cancer Research
Cancer Research Institute
Study Chair: Michael A Postow, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Hassane M Zarour, MD University of Pittsburgh
Principal Investigator: Craig L Slingluff, MD University of Virginia
Ludwig Institute for Cancer Research
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP