Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
|ClinicalTrials.gov Identifier: NCT01582672|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2012
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Renal Cell Carcinoma Renal Cell Carcinoma Metastatic Renal Cell Carcinoma||Drug: Standard Treatment Biological: AGS-003||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2018|
Experimental: AGS-003 + Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
Active Comparator: Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
Drug: Standard Treatment
Standard treatment for Renal Cell Carcinoma
Other Name: Sunitinib
- Overall Survival [ Time Frame: From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study ]Duration from randomization to death
- Progression Free Survival [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]
- Tumor Response [ Time Frame: From date of subject randomization to date of progression; assessed up to 42 months ]Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate.
- Monitor treatment emergent adverse events between both arms [ Time Frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months ]Compare adverse events between both arms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582672
Show 125 Study Locations
|Principal Investigator:||Robert Figlin, MD, FACP||Cedars-Sinai Medical Center|
|Principal Investigator:||Christopher G Wood, MD, FACP||M.D. Anderson Cancer Center|