Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
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|ClinicalTrials.gov Identifier: NCT01582672|
Recruitment Status : Terminated (Lack of efficacy)
First Posted : April 23, 2012
Last Update Posted : June 14, 2018
|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)|
|Actual Enrollment :||462 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|
|Actual Primary Completion Date :||April 2018|
|Actual 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.
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): NCT01582672
|Principal Investigator:||Robert Figlin, MD, FACP||Cedars-Sinai Medical Center|
|Principal Investigator:||Christopher G Wood, MD, FACP||M.D. Anderson Cancer Center|