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PF-06801591

DRUG8 trials

Sponsors

Fundacion De investigacion De Hm Hospitales, Associacio Per A La Recerca Oncologica, Pfizer, Maastricht University Medical Center

Conditions

Advanced MalignanciesBile Duct CancerEndometrial CancerEsophageal CancerGastric CancerHFILung Squamous Cell CarcinomaMELANOMA

Phase 1

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
CompletedNCT02573259
PfizerMELANOMA, NSCLC, OTHER SOLID TUMORS +6
Start: 2016-02-10End: 2020-11-19Updated: 2021-12-13
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
TerminatedNCT02616185
PfizerProstatic Neoplasms
Start: 2015-12-30End: 2021-02-23Updated: 2023-11-02
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
TerminatedNCT04152018
PfizerBile Duct Cancer, Endometrial Cancer, Esophageal Cancer +8
Start: 2019-11-13End: 2024-12-10Updated: 2025-05-28
Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
CompletedNCT04181788
PfizerAdvanced Malignancies, Non-small-cell Lung Cancer
Start: 2020-03-18End: 2026-05-13Updated: 2026-06-15

Phase 2

Ketohexokinase Inhibition in Hereditary Fructose Intolerance
CompletedNCT06089265
Maastricht University Medical CenterHFI
Start: 2023-06-15End: 2023-11-30Updated: 2024-01-24
Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients
RecruitingCTIS2024-511358-36-00
Fundacion De investigacion De Hm HospitalesMolecularly Categorized Muscle Invasive Bladder Cancer
Start: 2024-11-11Target: 70Updated: 2025-04-30
A phase II prospective, open-label, multi-centre, single arm study of sasanlimab plus sacituzumab govitecan in BCG (Bacillus Calmette-Guérin)- unresponsive non-muscle invasive bladder cancer (NMIBC) patients.
Active, not recruitingCTIS2024-518486-10-00
Associacio Per A La Recerca OncologicaNon-Muscle Invasive Bladder Cancer
Start: 2023-02-23Target: 42Updated: 2025-09-10

Phase 3

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
Active, not recruitingNCT04165317
PfizerNon-muscle Invasive Bladder Cancer
Start: 2019-12-30End: 2026-12-02Updated: 2026-01-22

Related Papers

The Evolving Landscape of Systemic Immunotherapy for Bacillus Calmette-Guérin-naïve High-risk Non-muscle-invasive Bladder Cancer: At the Edge of a Tsunami?
2025-08-051 citations
Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial
Nature Medicine2025-05-3130 citations
Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study.
Journal of Clinical Oncology2025-05-281 citations
Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Patient-reported outcomes (PROs) from CREST.
Journal of Clinical Oncology2025-05-28
Real-World and Clinical Trial Validation of a Deep Learning Radiomic Biomarker for PD-(L)1 Immune Checkpoint Inhibitor Response in Advanced Non–Small Cell Lung Cancer
JCO Clinical Cancer Informatics2024-12-019 citations
Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies.
2024-09-11
Real-world and clinical trial validation of a deep learning radiomic biomarker for PD-(L)1 immune checkpoint inhibitor response in stage IV NSCLC.
Journal of Clinical Oncology2024-05-29
First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC)
Journal for ImmunoTherapy of Cancer2023-03-0116 citations
A phase 3 study of the subcutaneous programmed cell death protein 1 inhibitor sasanlimab as single agent for patients with bacillus Calmette-Guérin, unresponsiv,e high-risk, non-muscle invasive bladder cancer: CREST Study Cohort B.
Journal of Clinical Oncology2022-06-013 citations
Association of Tumor Mutational Burden and Immune Gene Expression with Response to PD-1 Blockade by Sasanlimab Across Tumor Types and Routes of Administration
Targeted Oncology2021-10-253 citations
First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2021-05-203 citations
Abstract CT138: Molecular markers in a phase I dose expansion study of PF-06801591 in locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma
Cancer Research2020-08-15
Abstract CT046: Predictive biomarkers and pharmacodynamic changes in tumor RNA expression in a phase I study of anti PD-1 monoclonal antibody PF-06801591
Cancer Research2019-07-01
Abstract CT046: Predictive biomarkers and pharmacodynamic changes in tumor RNA expression in a phase I study of anti PD-1 monoclonal antibody PF-06801591
Clinical Trials2019-07-01
Assessment of Subcutaneous vs Intravenous Administration of Anti–PD-1 Antibody PF-06801591 in Patients With Advanced Solid Tumors
JAMA Oncology2019-05-3066 citations