Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: IMO-2055


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Previous treatment, 0.16mg/kg<br>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 | Drug: IMO-2055<br>* immunostimulatory oligonucleotide<br>|
| Active Comparator: Previous treatment, 0.64mg/kg<br>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 | Drug: IMO-2055<br>* immunostimulatory oligonucleotide<br>|
| Active Comparator: Treatment Naive, 0.16mg/kg<br>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 | Drug: IMO-2055<br>* immunostimulatory oligonucleotide<br>|
| Active Comparator: Treatment Naive, 0.64mg/kg<br>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 | Drug: IMO-2055<br>* immunostimulatory oligonucleotide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal, cell, renal carcinoma, metastatic, recurrent, treatment naive