Phase 3
Completed N=129
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
Source: ClinicalTrials.gov NCT03260894 ↗Enrolled (actual)
129
Serious AEs
26.0%
Results posted
Sep 2019
Primary outcomePrimary: Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC) — 1.6; 0.0; 29.7; 29.2 percentage of participants
◆ Published Evidence
Emerging
19citations · ~10 / year
A randomized, open-label, phase 3 trial of pembrolizumab plus epacadostat versus sunitinib or pazopanib as first-line treatment for metastatic renal cell carcinoma (KEYNOTE-679/ECHO-302).
Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.
Linked Publications
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A randomized, open-label, phase 3 trial of pembrolizumab plus epacadostat versus sunitinib or pazopanib as first-line treatment for metastatic renal cell carcinoma (KEYNOTE-679/ECHO-302).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC) |
1.6; 0.0; 29.7; 29.2; 31.3; 29.2 | — |
| SECONDARY Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs) |
64; 63 | — |
| SECONDARY Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs |
8; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
- Must not have received any prior systemic therapy for their mRCC.
- Measurable disease based on RECIST v1.1.
- Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
- Karnofsky performance status ≥ 70%.
- Adequate organ function per protocol-defined criteria.
Exclusion Criteria
- Use of protocol-defined prior/concomitant therapy.
- Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
- History of severe hypersensitivity reaction to study treatments or their excipients.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Known additional malignancy that has progressed or has required active treatment in the last 3 years.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
- History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
- Significant cardiac event within 12 months before Cycle 1 Day 1.
Data sourced from ClinicalTrials.gov (NCT03260894) and the linked publication. 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. Informational only — not medical advice.