Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMO-2055 | Drug | immunostimulatory oligonucleotide |
|
| 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. |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alice Bexon, MD | Idera Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University, Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
Not provided
| Label | URL |
|---|---|
| Sponsor Website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Previous Treatment, 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 0.16mg/kg IMO-2055: immunostimulatory oligonucleotide |
| FG001 | Previous Treatment, 0.64mg/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 IMO-2055: immunostimulatory oligonucleotide |
| FG002 | Treatment Naive, 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 0.16mg/kg IMO-2055: immunostimulatory oligonucleotide |
| FG003 | Treatment Naive, 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 0.64mg/kg IMO-2055: immunostimulatory oligonucleotide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Previous Treatment, 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 0.16mg/kg IMO-2055: immunostimulatory oligonucleotide |
| BG001 | Previous Treatment, 0.64mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at the time of screening. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT Population | Posted | Count of Participants | Participants | 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. |
|
From the first dose of study drug to 30 days after the final dose of study drug (up to 28 weeks).
Treatment-Emergent AEs were defined as those events which were not present at the pre-study evaluation, or worsened in severity after the start of treatment. Any AEs starting after study completion or withdrawal were not tabulated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Previous Treatment, 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 0.16mg/kg IMO-2055: immunostimulatory oligonucleotide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA v7.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA v7.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Idera Medical Monitor | Idera Pharmaceuticals, Inc. | 617-679-5500 | clinicaltrials@iderapharma.com |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C587694 | IMO-2055 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
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 IMO-2055: immunostimulatory oligonucleotide |
| BG002 | Treatment Naive, 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 0.16mg/kg IMO-2055: immunostimulatory oligonucleotide |
| BG003 | Treatment Naive, 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 0.64mg/kg IMO-2055: immunostimulatory oligonucleotide |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Previous Treatment, 0.64mg/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 IMO-2055: immunostimulatory oligonucleotide |
| OG002 | Treatment Naive, 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 0.16mg/kg IMO-2055: immunostimulatory oligonucleotide |
| OG003 | Treatment Naive, 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 0.64mg/kg IMO-2055: immunostimulatory oligonucleotide |
|
|
| Secondary | 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. | Safety Population | Posted | Count of Participants | Participants | From start of treatment through one month after the end of study visit (up to 28 weeks) |
|
|
|
| Secondary | 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. | Participants with reported response as reflected in Outcome Measure 1 | Posted | Number | Days | 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. |
|
|
|
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | 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. |
|
|
|
| Secondary | 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. | ITT Population | Posted | Median | 95% Confidence Interval | Days | Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression |
|
|
|
| 0 |
| 23 |
| 6 |
| 23 |
| 23 |
| 23 |
| EG001 | Previous Treatment, 0.64mg/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 IMO-2055: immunostimulatory oligonucleotide | 1 | 23 | 10 | 23 | 23 | 23 |
| EG002 | Treatment Naive, 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 0.16mg/kg IMO-2055: immunostimulatory oligonucleotide | 1 | 23 | 5 | 23 | 21 | 23 |
| EG003 | Treatment Naive, 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 0.64mg/kg IMO-2055: immunostimulatory oligonucleotide | 1 | 23 | 8 | 23 | 22 | 23 |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Chest pains | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Hypertenisve heart disease | Cardiac disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v7.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v7.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v7.1 | Non-systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v7.1 | Non-systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v7.1 | Non-systematic Assessment |
|
| Ovarian epithelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v7.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Abdomen wall abcess | Infections and infestations | MedDRA v7.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v7.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA v7.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v7.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Renal failure, acute | Renal and urinary disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Anticoagulant above therapeutic range | Investigations | MedDRA v7.1 | Non-systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Mental status change | Psychiatric disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Peripheral edema | General disorders | MedDRA v7.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v7.1 | Non-systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| Patients with at least 1 serious TEAE |
|
| Patients with a TEAE related to treatment |
|
| Patients with at least 1 severe (Grade+) TEAE |
|