Phase 2
N=92
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00729053 ↗Enrolled (actual)
92
Serious AEs
31.5%
Results posted
Jun 2018
Primary outcome: Primary: Best Response by RECIST v1.0 — 0; 1; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMO-2055 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Idera Pharmaceuticals, Inc.
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Response by RECIST v1.0 |
0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity |
23; 23; 21; 22; 6; 10 | — |
| SECONDARY Duration of Response by RECIST v1.0 |
179; 52 | — |
| SECONDARY Overall Survival at 1 Year |
15; 14; 14; 15 | — |
| SECONDARY Time to Disease Progression. |
103.0; 131.0; 138.5; 59.0 | — |
Summary
* Multi-Center
* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
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.
Data sourced from ClinicalTrials.gov (NCT00729053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.