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Monoclonal Antibodies
Avelumab for Renal Cell Carcinoma
Phase 1
Waitlist Available
Led By Vivek Narayan, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with history of treated brain metastases are eligible if off systemic corticosteroids for at least 2 weeks.
Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused) Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial is testing a new combination therapy for kidney cancer that has spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Side effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Investigations
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Immune system disorders
6%
Cardiac disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Infections and infestations
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
Gemcitabine
FDA approved
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,129 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
384 Previous Clinical Trials
144,910 Total Patients Enrolled
Vivek Narayan, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
4 Previous Clinical Trials
160 Total Patients Enrolled
Frequently Asked Questions
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