A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301) (ILLUMINATE-301)
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|ClinicalTrials.gov Identifier: NCT03445533|
Recruitment Status : Active, not recruiting
First Posted : February 26, 2018
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Ipilimumab Drug: IMO-2125||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||454 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)|
|Actual Study Start Date :||May 30, 2018|
|Estimated Primary Completion Date :||June 22, 2021|
|Estimated Study Completion Date :||September 3, 2021|
Experimental: Arm A: ipilimumab
ipilimumab 3 mg/kg intravenous
4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.
Other Name: Yervoy®
Experimental: Arm B: IMO-2125 plus ipilimumab
IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous
IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24.
Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11.
Other Name: Yervoy
- Compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone [ Time Frame: OS is measured from the date of randomization to the date of death from any cause (up to 56 months). ]Efficacy measured by overall survival (OS)
- Compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone [ Time Frame: Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months). ]Efficacy measure by overall response rate (ORR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445533
|Study Director:||Idera Medical Director||Idera Pharmaceuticals, Inc.|