A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Drug: Axitinib; Drug: MK-3475

Study type: Interventional

Funder types: Industry

Identifiers

NCT02133742

A4061079

KN-035 (Other Identifier)

Details and patient eligibility

About

Despite substantial improvements of patients outcome in advanced RCC, durable and complete response is uncommon. The majority of patients eventually develop resistance and exhibit disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with axitinib may provide additional clinical benefit compared to axitinib alone.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype with primary tumor resected
• At least one measureable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
• Eastern Cooperative Oncology Group performance status 0 or 1
• Controlled hypertension

Exclusion criteria

• Prior treatment with systemic therapy for advanced RCC
• Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
• Prior treatment with any agent specifically targeting T-cell co-stimulation or checkpoint pathways
• Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
• Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of randomization except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with no plans for treatment intervention
• In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
• In past 6 months: deep vein thrombosis or pulmonary embolism

Trial design

52 participants in 1 patient group

Dose finding phase and dose expansion phase

Experimental group

Description:

To test the maximum tolerated dose of MK-3475 at 2 mg/kg every three weeks intravenous infusion in combination with approved axitinib dose

Treatment:

Drug: MK-3475

Drug: Axitinib