Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

Incyte

Status and phase: Active, not recruiting; Phase 3

Conditions: Renal Cell Carcinoma (RCC)

Treatments: Drug: Pazopanib; Drug: Epacadostat; Drug: Sunitinib; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03260894

2017-002259-26 (EudraCT Number)

KEYNOTE-679/ECHO-302

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

Pembrolizumab + Epacadostat

Experimental group

Treatment:

Drug: Pembrolizumab

Drug: Epacadostat

SoC (Sunitinib or Pazopanib)

Active Comparator group

Description:

Standard of care (SoC) (sunitinib or pazopanib monotherapy).

Treatment:

Drug: Sunitinib

Drug: Pazopanib