NCT02451423 is a Phase 2 clinical trial of Atezolizumab in Carcinoma, Transitional Cell, sponsored by Lawrence Fong.

Who is sponsoring NCT02451423?

NCT02451423 is sponsored by Lawrence Fong.

What drugs are being tested in NCT02451423?

Interventions in NCT02451423: Atezolizumab.

What condition does NCT02451423 study?

NCT02451423 studies Carcinoma, Transitional Cell.

Is NCT02451423 still recruiting?

NCT02451423 is currently completed. Last updated 31 May 2024.

Are results published for NCT02451423?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-05-31 · How we verify

NCT02451423

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neoadjuvant Atezolizumab in Localized Bladder Cancer

Completed Phase 2 Results posted Last updated 31 May 2024

What this trial tests

Phase 2 trial testing Atezolizumab in Carcinoma, Transitional Cell in 23 participants. Completed in 31 March 2023.

Timeline

29 March 2016

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Lawrence Fong
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	29 March 2016
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across United States

Drugs / interventions tested

Atezolizumab (atezolizumab) — full drug profile →

Conditions studied

Carcinoma, Transitional Cell — all drugs for Carcinoma, Transitional Cell →

Sponsor

Lawrence Fong — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Transitional Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean log2 (Fold Change of CD3+ T-Cell Count/µm2) Over Time Primary · Up to 1 year

The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the Cluster of differentiation 3 positive (CD3+) T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	-0.036	-3.326 – 3.253
Cohort A2: Atezolizumab Monotherapy (2 Doses)	-0.041	-2.184 – 2.103
Cohort A3: Atezolizumab Monotherapy (3 Doses)	1.516	0.653 – 2.379

Mean log2 (Fold Change of CD4+ FoxP3- Helper T Cell Count/µm2) Over Time Primary · Up to 1 year

The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the cluster of differentiation 4 positive (CD4+) FoxP3- helper T cells count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0.829	-1.818 – 3.477
Cohort A2: Atezolizumab Monotherapy (2 Doses)	0.831	-1.105 – 2.768
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0.66	-0.637 – 1.958

Mean log2 (Fold Change of CD4+ FoxP3+ Regulatory T Cell Count/µm2) Over Time Primary · Up to 1 year

The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the CD4+ FoxP3+ regulatory T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	1.556	0.664 – 2.447
Cohort A2: Atezolizumab Monotherapy (2 Doses)	2.903	2.686 – 3.12
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0.238	-1.215 – 1.692

Mean log2 (Fold Change of CD8+ Cytotoxic T Cell Count/µm2) Over Time Primary · Up to 1 year

The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the cluster of differentiation 8 positive (CD8+) cytotoxic T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0.937	-0.496 – 2.369
Cohort A2: Atezolizumab Monotherapy (2 Doses)	0.666	-0.992 – 2.324
Cohort A3: Atezolizumab Monotherapy (3 Doses)	2.017	0.384 – 3.65

Percentage of Participants With a Treatment-related Delay Primary · Up to 2 years

The percentage of participants requiring a treatment-related delay in surgery beyond 12 weeks from study start will be summarized using descriptive statistics.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0
Cohort A2: Atezolizumab Monotherapy (2 Doses)	0
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0

Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery Primary · Up to 2 years

Treatment-related adverse events occurring prior to surgery will be summarized by maximum toxicity grade for all participants treated with a particular regimen. The grade of toxicity will be calculated using NCI CTCAE version 4.0.

Diarrhea

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	1
Cohort A2: Atezolizumab Monotherapy (2 Doses)	0
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0

Abdominal Pain

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	1
Cohort A2: Atezolizumab Monotherapy (2 Doses)	0
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0

Rash maculo-papular

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0
Cohort A2: Atezolizumab Monotherapy (2 Doses)	1
Cohort A3: Atezolizumab Monotherapy (3 Doses)	2

Musculoskeletal and connective tissue disorder - Other (Joint Ache)

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0
Cohort A2: Atezolizumab Monotherapy (2 Doses)	1
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0

Fatigue

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0
Cohort A2: Atezolizumab Monotherapy (2 Doses)	2
Cohort A3: Atezolizumab Monotherapy (3 Doses)	3

Hematuria

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0
Cohort A2: Atezolizumab Monotherapy (2 Doses)	1
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0

Headache

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0
Cohort A2: Atezolizumab Monotherapy (2 Doses)	1
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0

Alopecia

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0
Cohort A2: Atezolizumab Monotherapy (2 Doses)	1
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0

Near Complete Pathologic Response Rate Secondary · Up to 2 years

Point estimates and 95% confidence intervals of the near complete pathologic response rate, defined as the presence of only pTa or pTis in patients with T2 or greater disease at baseline.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	0.2967	0.03005 – 0.5635
Cohort A2: Atezolizumab Monotherapy (2 Doses)	0	NA – NA
Cohort A3: Atezolizumab Monotherapy (3 Doses)	0	NA – NA

Relapse-free Survival (RFS) Rate Intention-To-Treat (ITT) Population Secondary · Up to 2 years

The percentage of participants with a two- year RFS defined from study start until recurrence of disease or death from any cause, will be obtained using the Kaplan Meier method for the ITT population.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	67	38 – 100
Cohort A2: Atezolizumab Monotherapy (2 Doses)	83	58 – 100
Cohort A3: Atezolizumab Monotherapy (3 Doses)	82	62 – 100

Overall Survival Rate Secondary · Up to 2 years

Overall survival rate will be reported as the percentage of participants from study start until death from any cause obtained by Kaplan Meier method for the ITT population.

Group	Value	95% CI
Cohort A1: Atezolizumab Monotherapy (Single Dose)	80	52 – 100
Cohort A2: Atezolizumab Monotherapy (2 Doses)	83	59 – 100
Cohort A3: Atezolizumab Monotherapy (3 Doses)	100	100 – 100

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A1: Atezolizumab Monotherapy (Single Dose)

Serious: 1/6 (17%)

Deaths: 1/6

Cohort A2: Atezolizumab Monotherapy (2 Doses)

Serious: 0/6 (0%)

Deaths: 1/6

Cohort A3: Atezolizumab Monotherapy (3 Doses)

Serious: 0/11 (0%)

Deaths: 0/11

Serious adverse events (1 terms)

Reaction	System	Cohort A1: Atezolizumab Mo…	Cohort A2: Atezolizumab Mo…	Cohort A3: Atezolizumab Mo…
Kidney infection	Infections and infestations	—	—	—

Other adverse events (52 terms — click to expand)

Reaction	System	Cohort A1: Atezolizumab Mo…	Cohort A2: Atezolizumab Mo…	Cohort A3: Atezolizumab Mo…
Fatigue	General disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Creatinine increased	Investigations	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Weight loss	Investigations	—	—	—
Hematuria	Renal and urinary disorders	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Fever	General disorders	—	—	—
Localized edema	General disorders	—	—	—
Pain	General disorders	—	—	—
Chills	General disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Fecal incontinence	Gastrointestinal disorders	—	—	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—	—	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—	—	—
Malabsorption	Gastrointestinal disorders	—	—	—
Kidney infection	Infections and infestations	—	—	—
Upper respiratory infection	Infections and infestations	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Aortic injury	Injury, poisoning and procedural complications	—	—	—
Fracture	Injury, poisoning and procedural complications	—	—	—
Injury, poisoning and procedural complications - Other, specify	Injury, poisoning and procedural complications	—	—	—
Intestinal stoma site bleeding	Injury, poisoning and procedural complications	—	—	—
Seroma	Injury, poisoning and procedural complications	—	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—	—
Urinary incontinence	Renal and urinary disorders	—	—	—
Chronic kidney disease	Renal and urinary disorders	—	—	—
Renal and urinary disorders - Other, specify	Renal and urinary disorders	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
White blood cell decreased	Investigations	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Kidney infection.

Data from ClinicalTrials.gov NCT02451423 adverse events section.

Sponsor's own description

This phase II trial studies the best dose of atezolizumab in treating patients with bladder cancer that has not spread to other places in the body. Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Intratumoral CD4<sup>+</sup> T Cells Mediate Anti-tumor Cytotoxicity in Human Bladder Cancer.
Oh DY, Kwek SS, Raju SS, Li T, et al · · 2020 · cited 615× · PMID 32497499 · DOI 10.1016/j.cell.2020.05.017
Bladder Cancer: Current Challenges and Future Directions.
Dobruch J, Oszczudłowski M. · · 2021 · cited 280× · PMID 34440955 · DOI 10.3390/medicina57080749
Implications of the tumor immune microenvironment for staging and therapeutics.
Taube JM, Galon J, Sholl LM, Rodig SJ, et al · · 2018 · cited 277× · PMID 29192647 · DOI 10.1038/modpathol.2017.156
New Strategies in Bladder Cancer: A Second Coming for Immunotherapy.
Ghasemzadeh A, Bivalacqua TJ, Hahn NM, Drake CG. · · 2016 · cited 56× · PMID 26683632 · DOI 10.1158/1078-0432.ccr-15-1135
Immune checkpoint inhibitors in urothelial cancer: recent updates and future outlook.
Gopalakrishnan D, Koshkin VS, Ornstein MC, Papatsoris A, et al · · 2018 · cited 52× · PMID 29892196 · DOI 10.2147/tcrm.s158753
Immune Checkpoint Inhibitors as a Neoadjuvant/Adjuvant Treatment of Muscle-Invasive Bladder Cancer: A Systematic Review.
Barone B, Calogero A, Scafuri L, Ferro M, et al · · 2022 · cited 43× · PMID 35626149 · DOI 10.3390/cancers14102545
A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma.
Hsu FS, Su CH, Huang KH. · · 2017 · cited 29× · PMID 29376081 · DOI 10.1155/2017/6940546
Systemic Immunotherapy for Urothelial Cancer: Current Trends and Future Directions.
Gupta S, Gill D, Poole A, Agarwal N. · · 2017 · cited 29× · PMID 28134806 · DOI 10.3390/cancers9020015

Verify or expand the search:

Other trials of Atezolizumab

Trials testing the same drug.

NCT07388524 — Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer · Phase 3 · not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec · Phase 3 · not yet recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit · Phase 1, PHASE2 · recruiting

Other recruiting trials for Carcinoma, Transitional Cell

Currently open trials in the same condition.

NCT04660929 — CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors · Phase 1 · active not recruiting

Other Lawrence Fong trials

Trials by the same sponsor.

NCT03007719 — Functional Imaging of T-Cell Activation With [18F]F-AraG in Urothelial Carcinoma Patients Receiving Neoadjuvant Therapy · Phase 2 · terminated
NCT02506114 — Neoadjuvant PROSTVAC-VF With or Without Ipilimumab for Prostate Cancer · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02451423 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lawrence Fong
Last refreshed: 31 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02451423.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing