A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib and MK-3475 in Subjects with Advanced Renal Cell Carcinoma

ovartis Pharma Services AG0 sites42 target enrollmentJanuary 20, 2014

ConditionsRenal Cell Carcinoma MedDRA version: 20.1Level: PTClassification code 10073251Term: Clear cell renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsVotrient Keytruda

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: ovartis Pharma Services AG
Enrollment: 42
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 20, 2014

End Date

February 17, 2019

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•1\. Signed written informed consent before performance of study\-specific procedures or assessments and must be willing to comply with treatment and follow\-up.
•Informed consent may be obtained before the start of the specified screening
•window. Procedures conducted as part of the patients routine clinical management (e.g blood count, imaging study such as bone scan) and obtained before signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
•2\. Diagnosis of locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to AJCC staging) that is predominantly clear cell histology. Cytology cannot be the only pathologic criteria to confirm clear cell RCC.
•3\. Must have measurable disease, i.e. presenting with at least one measurable lesion. A measurable lesion is defined for target lesions as equal to or greater than 10mm in one dimension by computerized tomography (\[CT] or magnetic resonance imaging \[MRI]) scan with scan thickness being no greater than 5mm. For lymph nodes to be considered pathologically enlarged and measurable by CT scan, the short\-axis line\-length must be equal to or greater than 15mm and scan thickness no greater than 5mm.
•4\. Patient has received no prior systemic therapy.
•5\. Male or female \=18 years of age or legal age of consent if greater than 18 years.
•6\. A woman is eligible to participate in the study if she is of:
•6a. Non\-childbearing potential, including any female who; Has had a hysterectomy,Has had a bilateral oophorectomy (ovariectomy), Has had a bilateral tubal ligation, Is post\-menopausal (total cessation of menses for \=1 year).
•6b. Childbearing potential, has a negative serum beta\-human chorionic gonadotropin(beta\-HCG) pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120

Exclusion Criteria

•1\. Patient has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require use of bronchodilators or local steroid injections may not be excluded from the study if agreed by the investigator and GSK medical monitor. Patients with hypothyroidism stable on hormone replacement will not be
•excluded from the study.
•2\. Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment.
•3\. Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
•4\. Patient is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment. Patient is on any other form of immunosuppressive medication.
•5\. Patient has a history of a malignancy (other than the disease under treatment in the study) within 5 years before first study treatment administration. Shorter intervals can be considered after discussion with sponsor.
•6\. Central nervous system metastasis.
•Note: A baseline brain CT or MRI scan must be obtained in all subjects within 4 weeks of the first dose of study treatment.
•7\. Unable to swallow and retain orally administered medication. Malabsorption syndrome or disease that significantly affects GI function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib.
•8\. Patient has interstitial lung disease or a history of pneumonitis.