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Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Carcinoma; Clear-cell Metastatic Renal Cell Carcinoma

Intervention: Nivolumab (Biological); Pazopanib (Biological); Sunitinib (Drug); Ipilimumab (Biological)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.

Clinical Details

Official title: A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of Adverse event (AE)

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of Serious adverse event (SAE)

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Safety and tolerability of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by incidence of lab abnormality

Secondary outcome:

Antitumor activity of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by Objective Response Rate (ORR)

Antitumor activity of Nivolumab plus Sunitinib, Pazopanib, or Ipilimumab measured by duration of response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com Inclusion Criteria:

- Subjects with histological confirmation of RCC

- Advanced or metastatic disease

- Measurable disease as defined by RECIST 1. 1 criteria

- Karnofsky Performance Status (KPS) ≥80%

- Available tumor tissue (archival or recent acquisition)

- Subjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have

received any prior systemic therapy for RCC with the following exceptions: 1. One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ≥ 6 months after the last dose of the adjuvant or neoadjuvant therapy 2. Only prior cytokine based treatment for metastatic RCC [eg, interferon-alpha (IFN-alpha) or interleukin 2 (IL-2)] as prior therapy is allowed Exclusion Criteria:

- Active central nervous system (CNS) metastases

- Active or history of autoimmune disease

- Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation

- History of cerebrovascular accident including transient ischemic attack within the

past 12 months

- History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months

- Chronic systemic steroids (>10 mg/day Prednisone equivalents) or any other

immunosuppressive agents

- White blood cell (WBC) <2,000/mm3

- Neutrophiles <1,500/mm3

- Platelets <100,000/mm3

- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x upper limit of

normal (ULN)

- Total Bilirubin >1. 5x ULN (except subjects with Gilbert syndrome, total bilirubin

<3. 0 mg/dL)

- Cardiac ejection fraction

- Serum creatinine >1. 5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault

formula) Exclusion Criteria for Arm S and Arm P only:

- For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and

required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and Pazopanib

- Poorly controlled hypertension

- Active bleeding or bleeding susceptibility

Locations and Contacts

Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Bc Cancer Agency - Vancouver Centre, Vancouver, British Columbia V5Z 4E6, Canada

City Of Hope, Duarte, California 91010, United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland 21231, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Memorial Sloan Kettering Cancer Center, New York, New York 11065, United States

Levine Cancer Institute, Charlotte, North Carolina 28204, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

Local Institution, Ottawa, Ontario K1H 8L6, Canada

Princess Margaret Hospital-Uhn, Toronto, Ontario M5G 2M9, Canada

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Tennessee Oncology, Pllc, Nashville, Tennessee 37203, United States

The University Of Texas Md Anderson Cancer Center, Houston, Texas 77030, United States

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: January 2012
Last updated: August 19, 2015

Page last updated: August 23, 2015

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