Renal Cell CarcinomaPhase 2NCT00729053
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
A Phase 2 study testing IMO-2055 in people with Renal Cell Carcinoma, run by Idera Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Multi-Center Randomized Open-Label Study of single agent IMO-2055 Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- IMO-2055
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known untreated central nervous system (CNS) metastasis
- Pre-existing autoimmune or antibody-mediated diseases
- Other significant medical disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University, Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
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
- Multi-Center
- Randomized
- Open-Label Study of single agent IMO-2055
- Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- IMO-2055
- Keywords
- renal, cell, renal carcinoma, metastatic, recurrent, treatment naive
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMO-2055Drug
immunostimulatory oligonucleotide
| Study group | Role | What they receive |
|---|---|---|
| Previous treatment, 0.16mg/kg | Active comparator | 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 Receives: Drug: IMO-2055 |
| Previous treatment, 0.64mg/kg | Active comparator | 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 Receives: Drug: IMO-2055 |
| Treatment Naive, 0.16mg/kg | Active comparator | 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 Receives: Drug: IMO-2055 |
| Treatment Naive, 0.64mg/kg | Active comparator | 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 Receives: Drug: IMO-2055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (4)
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.
Measured: From start of treatment through one month after the end of study visit (up to 28 weeks)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startJun 2004
- Primary completionApr 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idera Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alice Bexon, MD, Study director, Idera Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729053
- Sponsor's protocol ID
- 2055-003
- Status last verified
- May 2018
- First submitted
- 1 Aug 2008
- Last updated
- 12 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00729053
- Acronym / sponsor ID
- 2055-003
- Conditions
- Renal Cell Carcinoma
- Keywords
- renal, cell, renal carcinoma, metastatic, recurrent, treatment naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Idera Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Previous treatment, 0.16mg/kg | Active comparator | Drug: IMO-2055Patients 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 |
| Previous treatment, 0.64mg/kg | Active comparator | Drug: IMO-2055Patients 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 |
| Treatment Naive, 0.16mg/kg | Active comparator | Drug: IMO-2055Patients 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 |
| Treatment Naive, 0.64mg/kg | Active comparator | Drug: IMO-2055Patients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Known untreated central nervous system (CNS) metastasis
- Pre-existing autoimmune or antibody-mediated diseases
- Other significant medical disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMO-2055immunostimulatory oligonucleotide | Drug | Previous treatment, 0.16mg/kg, Previous treatment, 0.64mg/kg, Treatment Naive, 0.16mg/kg, Treatment Naive, 0.64mg/kg |
Primary outcome
Best Response by RECIST v1.0
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.
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.
4 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity
Time frame: From start of treatment through one month after the end of study visit (up to 28 weeks)
Duration of Response by RECIST v1.0
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.
Overall Survival at 1 Year
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.
Time to Disease Progression.
Time frame: Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Bexon, MD study director
Idera Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMO-2055 in people with Renal Cell Carcinoma, run by Idera Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Response by RECIST v1.0 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.