- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03359239
Atezolizumab Given in Combination With a Personalized Vaccine in Patients With Urothelial Cancer
Pilot Study of Atezolizumab Plus PGV001, a Multipeptide Personalized Neoantigen Vaccine, in Patients With Locally Advanced or Metad or Metastatic Urothelial Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written informed consent and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 1 within fourteen days of registration for protocol therapy.
- Histological or cytological evidence of urothelial cancer of the bladder, urethra, ureter, or renal pelvis. Differentiation with variant histologies (e.g., squamous cell differentiated) or pure variant histologies will be permitted provided that the predominant histology is urothelial carcinoma.
Clinical disease state specific criteria:
- Subjects with invasive urothelial cancer of the bladder or upper urinary tract may consent either before or within 6 weeks after radical cystectomy or nephroureterectomy.
- Subjects with metastatic and/or unresectable disease must have a metastatic site amenable to biopsy. In situations where a metastatic biopsy does not yield sufficient genetic material for sequencing, or a biopsy cannot be feasibly performed, the use of archival tumor tissue may be considered on a case by case basis. The archival tissue must be derived from a muscle-invasive urothelial cancer specimen or metastatic urothelial cancer specimen.
Required laboratory values must be obtained within thirty days of consent.
- ANC ≥ 1500 cells/µL
- WBC counts > 2500/µL
- Lymphocyte count ≥ 300/µL
- Platelet count ≥ 100,000/µL
- Hemoglobin ≥ 8.0 g/dL
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) with the following exception:
o Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled.
AST and ALT ≤ 3.0 x ULN with the following exception:
o Patients with liver involvement: AST and/or ALT ≤ 5 x ULN
Alkaline phosphatase ≤ 2.5 x ULN with the following exception:
o Patients with documented liver involvement or bone metastases: alkaline phosphatase ≤ 5 x ULN
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation:
- (140 - age) x (weight in kg) x (0.85 if female) / 72 x (serum creatinine in mg/dL)
- INR and aPTT ≤ 1.5 x ULN o This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.
Exclusion Criteria:
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
- Symptomatic CNS metastases and/or metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm) and/or history of intracranial hemorrhage or spinal cord hemorrhage
- Pregnancy, lactation, or breastfeeding
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
- Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
- Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
- Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection
- Active tuberculosis
- A known additional primary malignancy that is progressing or requires active treatment. Exceptions include cancers that have undergone potentially curative therapy.
Medication-Related Exclusion Criteria:
- Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents
- No history of severe immune-related adverse effects from anti-CTLA 4 (NCI CTCAE Grade 3 and 4)
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
Please contact site for other inclusion/exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PGV 001 with Atezolizumab
Atezolizumab: programmed death-ligand 1 PGV001:personalized cancer vaccine PGV 001 - vaccine Poly ICLC- adjuvant The product is prepared within the Icahn School of Medicine at Mount Sinai (ISMMS) .
The product consists of two independent preparations of patient specific long peptides mixed with poly-ICLC.
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1200 mg administered by IV infusion every 3 weeks (21 [+/-2] days) for up to 12 months in the adjuvant setting and up to 24 months in the metastatic setting.
Other Names:
PGV001: up to ten total doses of PGV001with helper peptides. The product is prepared within the ISMMS . The product consists of two independent preparations of patient specific long peptides mixed with poly-ICLC. A dose of PGV001 consists of the following: Up to ten synthetic peptides - 100μg (0.01 mL, 10 mg/mL) per peptide. One tetanus helper peptide - 100μg (0.01 mL, 10 mg/mL)
1.4 mg (0.7 mL, 2 mg/mL)
0.19 mL
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of neoantigens
Time Frame: up to 24 months
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Feasibility parameter: Number of neoantigens identified per subject
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up to 24 months
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Number of peptides synthesized
Time Frame: up to 24 months
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Feasibility parameter: Number of peptides synthesized per subject for vaccination
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up to 24 months
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Vaccine Production time
Time Frame: up to 24 months
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Feasibility parameter:
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up to 24 months
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Proportion of consent to tissue acquisition phase
Time Frame: up to 24 months
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Feasibility parameter: Proportion of subjects who consent to the tissue acquisition phase for whom a vaccine product is prepared
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up to 24 months
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Proportion of subjects eligible for the treatment phase
Time Frame: up to 24 months
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Feasibility parameter: Proportion of subjects eligible for the treatment phase who complete the priming course of vaccination plus atezolizumab
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up to 24 months
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Number of toxicities
Time Frame: up to 24 months
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Safety will be assessed by the frequency of toxicities as assessed by NCI-CTCAE 4.0 criteria
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up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: up to 24 hours
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Objective Response Rate by RECIST 1.1 .
RECIST: complete response, partial response, stable disease, and progressive disease.
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up to 24 hours
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Duration of response
Time Frame: up to 24 months
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The duration of response by RECIST 1.1 and immune-related RECIST criteria in patients with metastatic disease
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up to 24 months
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Time to Progression In Adjuvant patients
Time Frame: up to 24 months
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Time-to-progression in adjuvant patients using RECIST: complete response, partial response, stable disease, and progressive disease
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up to 24 months
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Overall Survival
Time Frame: up to 24 months
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Number of participants living
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up to 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Galsky, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 16-1387
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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