CompletedPhase 1NCT02015416

A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer

This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical safety and immune response of IDC-G305 when injected intramuscularly in patients with unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors include the NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer may be considered for the trial.

Checked against the public recordLast updated Aug 17, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations4
SponsorImmune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Interventions being studied
Biological: IDC-G305
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Confirmed diagnosis of melanoma, ovarian cancer, sarcoma, breast cancer or non-small cell lung cancer (NSCLC) * Unresectable, relapsed and/or metastatic cancer with minimal or low disease burden. Disease may or may not be measurable and should not be rapidly progressive. Inadequate response, relapse and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, except patients with NSCLC and breast cancer who must have experienced an inadequate response and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies. * Cancer expresses NY-ESO-1 * ≥ 18 years of age * Life expectancy of ≥ 6 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * ECG without evidence of clinically significant arrhythmia or ischemia * Negative pregnancy test for females of childbearing potential Exclusion Criteria: * Pregnant or nursing * Vaccine or other therapy directed against NY-ESO-1 at any time in the past and any investigational therapy within three weeks prior to IDC-G305 dosing * Significant immunosuppression * Cancer chemotherapy, G-CSF or GM-CSF within three weeks prior to the first study treatment * Significant autoimmune disease * Myocardial infarction within six months of treatment, active cardiac ischemia or Grade III or IV heart failure * Inadequate hematology or chemistry profiles * History of other cancer within three years * Active, concurrent or recent infection, including tuberculosis, hepatitis B, hepatitis C or HIV * Uveal melanoma * Brain metastases considered unstable

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Scottsdale HealthcareScottsdale, Arizona
  • H. Lee Moffitt Cancer CenterTampa, Florida
  • Karmanos Cancer InstituteDetroit, Michigan
  • Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 17, 2017. Always confirm current availability with the study team.

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