Back to resultsStudy of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IMO-2055
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring renal, cell, renal carcinoma, metastatic, recurrent, treatment naive
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed stage IV clear cell renal carcinoma with metastatic or locally recurrent disease that is not surgically resectable.
- At least one measurable lesion
- Adequate organ function
- Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.
- If female and of childbearing potential, a negative serum pregnancy test performed and documented no more than 14 days before the first dose of study drug.
Exclusion Criteria:
- Known untreated central nervous system (CNS) metastasis
- Pre-existing autoimmune or antibody-mediated diseases
- Other significant medical disease.
Sites / Locations
- Georgetown University, Lombardi Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Previous treatment, 0.16mg/kg
Previous treatment, 0.64mg/kg
Treatment Naive, 0.16mg/kg
Treatment Naive, 0.64mg/kg
Arm Description
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
Outcomes
Primary Outcome Measures
Best Response by RECIST v1.0
Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.
Secondary Outcome Measures
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Number of patients with Treatment-emergent adverse events (TEAEs) by National Cancer Institute (NCI) grade/severity that began on or after the date of the first injection of study drug or worsened in severity or frequency after study drug was administered.
Duration of Response by RECIST v1.0
Time in days from the date of the first response by RECIST v1.0 to documented disease progression or death from any cause.
Overall Survival at 1 Year
Overall survival is defined as (date of death +1 - date of randomization). Patients without an event (death) during treatment or follow-up will have their date censored on the last visit the patient was known to be alive.
Time to Disease Progression.
Time between the date of randomization to the Study Day of documented disease progression (an increase in tumor burden of at least 20%, appearance of new lesions, or unequivocal progression of non-measurable disease) or death (whichever comes first) by RECIST v1.0. Patients who had not progressed at last disease assessment, but whose progression status was unknown at the date last known alive, date of death, or date of study exit (whichever comes first), had event time censored at the date of last assessment. Patients who did not die and did not progress during treatment or follow-up had their event time censored on the last contact date.
Full Information
NCT ID
NCT00729053
First Posted
August 1, 2008
Last Updated
May 14, 2018
Sponsor
Idera Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00729053
Brief Title
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Official Title
A Phase 2, Multi-Center, Randomized, Open-Label Study of Two Dose Levels of IMOxine® (IMO-2055 for Injection) in Patients With Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idera Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multi-Center
Randomized
Open-Label Study of single agent IMO-2055
Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
Detailed Description
This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
renal, cell, renal carcinoma, metastatic, recurrent, treatment naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Previous treatment, 0.16mg/kg
Arm Type
Active Comparator
Arm Description
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
Arm Title
Previous treatment, 0.64mg/kg
Arm Type
Active Comparator
Arm Description
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
Arm Title
Treatment Naive, 0.16mg/kg
Arm Type
Active Comparator
Arm Description
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
Arm Title
Treatment Naive, 0.64mg/kg
Arm Type
Active Comparator
Arm Description
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
Intervention Type
Drug
Intervention Name(s)
IMO-2055
Intervention Description
immunostimulatory oligonucleotide
Primary Outcome Measure Information:
Title
Best Response by RECIST v1.0
Description
Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.
Time Frame
From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Description
Number of patients with Treatment-emergent adverse events (TEAEs) by National Cancer Institute (NCI) grade/severity that began on or after the date of the first injection of study drug or worsened in severity or frequency after study drug was administered.
Time Frame
From start of treatment through one month after the end of study visit (up to 28 weeks)
Title
Duration of Response by RECIST v1.0
Description
Time in days from the date of the first response by RECIST v1.0 to documented disease progression or death from any cause.
Time Frame
Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.
Title
Overall Survival at 1 Year
Description
Overall survival is defined as (date of death +1 - date of randomization). Patients without an event (death) during treatment or follow-up will have their date censored on the last visit the patient was known to be alive.
Time Frame
From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug.
Title
Time to Disease Progression.
Description
Time between the date of randomization to the Study Day of documented disease progression (an increase in tumor burden of at least 20%, appearance of new lesions, or unequivocal progression of non-measurable disease) or death (whichever comes first) by RECIST v1.0. Patients who had not progressed at last disease assessment, but whose progression status was unknown at the date last known alive, date of death, or date of study exit (whichever comes first), had event time censored at the date of last assessment. Patients who did not die and did not progress during treatment or follow-up had their event time censored on the last contact date.
Time Frame
Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed stage IV clear cell renal carcinoma with metastatic or locally recurrent disease that is not surgically resectable.
At least one measurable lesion
Adequate organ function
Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.
If female and of childbearing potential, a negative serum pregnancy test performed and documented no more than 14 days before the first dose of study drug.
Exclusion Criteria:
Known untreated central nervous system (CNS) metastasis
Pre-existing autoimmune or antibody-mediated diseases
Other significant medical disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Bexon, MD
Organizational Affiliation
Idera Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Georgetown University, Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Links:
URL
http://iderapharma.com
Description
Sponsor Website
Learn more about this trial
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
We'll reach out to this number within 24 hrs