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

Primary Purpose

Melanoma, Ovarian Cancer, Sarcoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

IDC-G305

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Ovarian cancer, Sarcoma, Non-small cell lung cancer, NSCLC, Breast cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Scottsdale Healthcare
H. Lee Moffitt Cancer Center
Karmanos Cancer Institute
Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IDC-G305

Arm Description

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

Outcomes

Primary Outcome Measures

Safety and tolerability

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

Secondary Outcome Measures

Immunogenicity

The secondary objective is to evaluate the humoral and cellular immunogenicity of multiple ascending doses of intramuscularly administered IDC-G305

Full Information

NCT ID

NCT02015416

First Posted

December 13, 2013

Last Updated

August 15, 2017

Sponsor

Immune Design

1. Study Identification

Unique Protocol Identification Number

NCT02015416

Brief Title

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

Official Title

A Phase 1 Open Label, Multicenter, Multiple Ascending Dose Trial Evaluating the Safety, Tolerability and Immunogenicity of Intramuscular Recombinant NY-ESO-1 Protein With GLA-SE Adjuvant in Patients With Unresectable or Metastatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immune Design

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is a Phase 1, open label, multicenter, multiple ascending dose trial of IDC-G305 administered by intramuscular injection in a 3+3 sequential dose escalation design. IDC-G305 is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE. Patients with unresectable, relapsed or metastatic cancer but with low disease burden and indolent disease course may be considered for the trial. Tumors must express the NY-ESO-1 gene signature and tumor types that will be studied are: melanoma, ovarian, sarcoma,non-small cell lung and breast cancer. Each of three dose level cohorts will be treated contingent upon absence of dose limiting toxicity (DLT) and acceptable safety data for the preceding cohort. Initially, three patients will be scheduled to receive IDC-G305 in each dose level cohort. Dose escalation will be contingent upon the assessment of safety data obtained during the initial injections. Patients will be evaluated at baseline and at regular intervals for safety and immune response. Both cellular and humoral immunogenicity will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Phase 1, open label, multicenter ascending dose study.

Masking

None (Open Label)

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDC-G305

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

IDC-G305

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety and tolerability

Description

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

Time Frame

Up to 1 year after last vaccination

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

The secondary objective is to evaluate the humoral and cellular immunogenicity of multiple ascending doses of intramuscularly administered IDC-G305

Time Frame

Approximately 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kunle Odunsi, MD PhD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scottsdale Healthcare

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

H. Lee Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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