Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC
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|ClinicalTrials.gov Identifier: NCT03260894|
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : September 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma (RCC)||Drug: Pembrolizumab Drug: Epacadostat Drug: Sunitinib Drug: Pazopanib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)|
|Actual Study Start Date :||December 7, 2017|
|Actual Primary Completion Date :||August 22, 2018|
|Estimated Study Completion Date :||June 2020|
Experimental: Group 1
Pembrolizumab + epacadostat
Pembrolizumab administered intravenously every 3 weeks.
Other Name: MK-3475
Epacadostat administered orally twice daily.
Other Name: INCB024360
Active Comparator: Group 2
Sunitinib or pazopanib
Sunitinib administered orally once daily.
Pazopanib administered orally once daily.
Other Name: Votrient
- Objective response rate of pembrolizumab + epacadostat versus standard of care (SOC) [ Time Frame: Up to 6 months ]Defined as proportion of participants who have a best response of complete response (CR) or partial response (PR) as measured per RECIST v1.1.
- Safety and tolerability of pembrolizumab + epacadostat and SOC as measured by number of participants experiencing adverse events (AEs) [ Time Frame: Up to 30 months ]AEs defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- Safety and tolerability of pembrolizumab + epacadostat and SOC as measured by number of participants discontinuing study drug due to AEs [ Time Frame: Up to 30 months ]AEs defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
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): NCT03260894
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|Study Director:||Mark Jones, MD||Incyte Corporation|