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Urothelial/Bladder Cancer, NosPhase 1NCT03359239

Atezolizumab Given in Combination With a Personalized Vaccine in Patients With Urothelial Cancer

A Phase 1 study testing Atezolizumab, PGV001 and Poly ICLC in people with Urothelial/Bladder Cancer, Nos, run by Matthew Galsky at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the good and bad effects of atezolizumab given in combination with a personalized cancer vaccine in patients with urothelial cancer either after surgery to remove organ where the tumor arose (for example, removal of the bladder) or for urothelial cancer that has spread to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial/Bladder Cancer, Nos
What is being tested?
Atezolizumab, PGV001 and Poly ICLC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
8 May 2019to 12 Oct 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Pilot Study of Atezolizumab Plus PGV001, a Multipeptide Personalized Neoantigen Vaccine, in Patients With Locally Advanced or Metad or Metastatic Urothelial Cancer

The purpose of this study is to determine the good and bad effects of atezolizumab given in combination with a personalized cancer vaccine in patients with urothelial cancer either after surgery to remove organ where the tumor arose (for example, removal of the bladder) or for urothelial cancer that has spread to other organs.

Read the detailed description

This is a single arm, proof-of-concept study. Fifteen subjects with urothelial cancer interested in participation will sign a "tissue acquisition and vaccine preparation consent" after which tumor tissue will be obtained from either a surgical resection specimen or biopsy. Subjects are scheduled to undergo cystectomy or nephroureterectomy for invasive urothelial cancer may consent prior to, or within 6 weeks after, surgery. The tumor specimen will be submitted for genomic sequencing followed by neoantigen identification utilizing a computational pipeline. Peptides corresponding to these neoantigens will be prepared for the personalized vaccine product. Subjects eligible for the treatment phase of the protocol (i.e., after surgery in adjuvant patients and chemotherapy in metastatic patients) will receive atezolizumab every 3 weeks plus up to ten doses of PGV001 vaccination plus Poly-ICLC. The primary objectives will be to determine the feasibility and safety of administration of a personalized neoantigen-based vaccine (PGV001) plus atezolizumab in subjects with locally advanced or metastatic urothelial cancer.

Being tested
Atezolizumab, PGV001, Poly ICLC, Normal saline
Keywords
PGV001, atezolizumab, urothelial cancer, personalized neoantigen vaccine
Medical subject headings
Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called TECENTRIQ

    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.

  • PGV001Biological

    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)

  • Poly ICLCDrug

    1.4 mg (0.7 mL, 2 mg/mL)

  • Normal salineDrug

    0.19 mL

Study groups in NCT03359239
Study groupRoleWhat they receive
PGV 001 with AtezolizumabExperimentalAtezolizumab: 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.
Receives: Drug: Atezolizumab; Biological: PGV001; Drug: Poly ICLC; Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of neoantigens

    Feasibility parameter: Number of neoantigens identified per subject

    Measured: up to 24 months

  2. Number of peptides synthesized

    Feasibility parameter: Number of peptides synthesized per subject for vaccination

    Measured: up to 24 months

  3. Vaccine Production time

    Feasibility parameter:

    Measured: up to 24 months

  4. Proportion of consent to tissue acquisition phase

    Feasibility parameter: Proportion of subjects who consent to the tissue acquisition phase for whom a vaccine product is prepared

    Measured: up to 24 months

  5. Proportion of subjects eligible for the treatment phase

    Feasibility parameter: Proportion of subjects eligible for the treatment phase who complete the priming course of vaccination plus atezolizumab

    Measured: up to 24 months

  6. Number of toxicities

    Safety will be assessed by the frequency of toxicities as assessed by NCI-CTCAE 4.0 criteria

    Measured: up to 24 months

Secondary outcomes (4)

  1. Objective Response Rate

    Objective Response Rate by RECIST 1.1 . RECIST: complete response, partial response, stable disease, and progressive disease.

    Measured: up to 24 hours

  2. Duration of response

    The duration of response by RECIST 1.1 and immune-related RECIST criteria in patients with metastatic disease

    Measured: up to 24 months

  3. Time to Progression In Adjuvant patients

    Time-to-progression in adjuvant patients using RECIST: complete response, partial response, stable disease, and progressive disease

    Measured: up to 24 months

  4. Overall Survival

    Number of participants living

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2017
  2. Study start8 May 2019
  3. Primary completion12 Oct 2021
  4. Study completion12 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03359239
Sponsor's protocol ID
GCO 16-1387
Status last verified
May 2023
First submitted
27 Nov 2017
Last updated
16 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Saxena M, Anker JF, Kodysh J, O'Donnell T, Kaminska AM, Meseck M, Hapanowicz O, Niglio SA, Salazar AM, Shah HR, Kinoshita Y, Brody R, Rubinsteyn A, Sebra RP, Bhardwaj N, Galsky MD. Atezolizumab plus personalized neoantigen vaccination in urothelial cancer: a phase 1 trial. Nat Cancer. 2025 Jun;6(6):988-999. doi: 10.1038/s43018-025-00966-7. Epub 2025 May 9.

    PubMed 40346292

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab, PGV001 and Poly ICLC in people with Urothelial/Bladder Cancer, Nos, run by Matthew Galsky at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of neoantigens (time frame: up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03359239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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