Pembrolizumab (MK-3475) plus Epacadostat vs SoC in mRCC

Phase 1

• Conditions: ocally advanced/metastatic renal cell carcinoma; MedDRA version: 21.1Level: PTClassification code: 10050513Term: Metastatic renal cell carcinoma Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512016-22-00
• Lead Sponsor: Incyte Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Histologic confirmation of locally advanced or metastatic renal cell carcinoma (mRCC) 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 Response Evaluation Criteria in Solid Tumors, version 1.1 (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified