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

NCT02015416 | Completed Phase 1 DMC

• 1 other identifier: IDC-G305-2013-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Melanoma; Ovarian Cancer; Sarcoma; Non-small Cell Lung Cancer; Breast Cancer

Keywords

Melanoma; Ovarian cancer; Sarcoma; Non-small cell lung cancer; NSCLC; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  To evaluate the safety and tolerability of multiple ascending doses of intramuscular (IM) IDC-G305

  Up to 1 year after last vaccination

Secondary Outcomes (1)

• Immunogenicity

  Approximately 12 weeks

Study Arms (1)

IDC-G305

EXPERIMENTAL

NY-ESO-1 recombinant protein together with GLA-SE

Biological: IDC-G305

Interventions

IDC-G305 BIOLOGICAL

NY-ESO-1 recombinant protein together with GLA-SE

IDC-G305

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (4)

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Melanoma; Ovarian Neoplasms; Sarcoma; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases

Study Officials

• Kunle Odunsi, MD PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1, open label, multicenter ascending dose study.

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)