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

NCT00729053 | Completed Phase 2 Results

• 1 other identifier: 2055-003
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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)

Conditions

Renal Cell Carcinoma

Keywords

renal; cell; renal carcinoma; metastatic; recurrent; treatment naive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity

  From start of treatment through one month after the end of study visit (up to 28 weeks)

• Duration of Response by RECIST v1.0

  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

  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.

  Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression

Study Arms (4)

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

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

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

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

Drug: IMO-2055

Interventions

IMO-2055 DRUG

immunostimulatory oligonucleotide

Previous treatment, 0.16mg/kg; Previous treatment, 0.64mg/kg; Treatment Naive, 0.16mg/kg; Treatment Naive, 0.64mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known untreated central nervous system (CNS) metastasis
• Pre-existing autoimmune or antibody-mediated diseases
• Other significant medical disease.

Sponsors & Collaborators

• Idera Pharmaceuticals, Inc.: lead

Study Sites (1)

Georgetown University, Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis; Recurrence

Interventions

IMO-2055

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Results Point of Contact

• Title: Idera Medical Monitor
• Organization: Idera Pharmaceuticals, Inc.

clinicaltrials@iderapharma.com

617-679-5500

Study Officials

• Alice Bexon, MD

  Idera Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 6, 2008
• Study Start: June 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 12, 2018
• Results First Posted: June 12, 2018

Record last verified: 2018-05

Locations

US (1)