A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426) - Pembrolizumab plus axitinib vs. sunitinib monotherapy in advanced/metastatic renal cell carcinoma

Merck Sharp & Dohme LLC0 sites840 target enrollmentAugust 8, 2016

DrugsINLYTA (axitinib)SUTENT (sunitinib malate)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 840
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 8, 2016

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Eligibility Criteria

Inclusion Criteria

•\- Be \> or \= 18 years of age on day of signing informed consent
•\- Have histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features
•\- Have locally advanced/metastatic disease, ie, newly diagnosed Stage IV RCC per American Joint Committee on Cancer or have recurrent disease.
•\- Have measurable disease per RECIST 1\.1 as assessed by the investigator /site radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
•\- Have received no prior systemic therapy for advanced RCC
•\- Provide tumor tissue for biomarker analysis
•\- Demonstrate adequate organ function
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•\- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
•\- Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., \= Grade 1 or at baseline) from AEs due to prior treatment.
•\- Has had prior treatment with any anti\-PD\-1, or PD\-L1, or PD\-L2 agent or an antibody targeting any other immune\-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD\-L1, IL\-2R, and GITR
•\- Has received prior systemic anti\-cancer therapy for RCC (e.g., VEGF/VEGFR, chemotherapy or mTOR\-targeting agents).
•\- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization
•\- Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease\-modifying agents, corticosteroids, or immunosuppressive drugs) OR with a documented history of clinically severe
•autoimmune disease
•\- Has a known additional malignancy that has progressed or has required active treatment in the last 3 years
•\- Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable
•\- Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis