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

Completed · Phase 1

Conditions studied: Melanoma, Ovarian Cancer, Sarcoma, Non-small Cell Lung Cancer, Breast Cancer

In brief

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.

Key facts

Study ID

NCT02015416

Run by

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

13

Starts

2013-11-01

Expected to finish

2017-03-01

Last updated by the study team

2017-08-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scottsdale Healthcare — Scottsdale, Arizona, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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