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 Corp., a subsidiary of Merck & Co., Inc.0 sites840 target enrollmentAugust 5, 2016

ConditionsAdvanced Kidney Cancer MedDRA version: 19.0Level: LLTClassification code 10023400Term: Kidney cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKeytruda INLYTA (axitinib)SUTENT (sunitinib malate)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Kidney Cancer
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 840
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 5, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

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 (i.e., 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. Target 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 prior to randomization or radiation therapy within 2 weeks prior to randomization, or who has not recovered (i.e., \< or \= 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 therapy with VEGF/VEGFR or mTOR targeting agents
•\- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization
•\- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents
•\- 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 stable
•\- Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis
•\- Has a clinically significant gastrointestinal (GI) abnormality including: Inability to take oral medication, Requirement for IV alimentation, Prior surgical procedures affecting absorption including total gastric resection, Treatment for active peptic ulcer within the past 6 months, Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy, Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation, or history of GI perforation, Malabsorption syndromes, Inflammatory bowel disease