NCT04165317 (CREST) is a Phase 3 clinical trial of PF-06801591 in Non-muscle Invasive Bladder Cancer, sponsored by Pfizer.

Who is sponsoring NCT04165317?

NCT04165317 is sponsored by Pfizer.

What drugs are being tested in NCT04165317?

Interventions in NCT04165317: PF-06801591, Bacillus Calmette-Guerin.

What condition does NCT04165317 study?

NCT04165317 studies Non-muscle Invasive Bladder Cancer.

Is NCT04165317 still recruiting?

NCT04165317 is currently active, enrolled. Last updated 22 January 2026.

Are results published for NCT04165317?

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

Last reviewed 2026-01-22 · How we verify

NCT04165317: CREST

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

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

Active, enrolled Phase 3 Results posted Last updated 22 January 2026

What this trial tests

Phase 3 trial testing PF-06801591 in Non-muscle Invasive Bladder Cancer in 1,068 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 December 2019

Primary endpoint
2 December 2024

2 December 2026

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,068
Start date	30 December 2019
Primary completion	2 December 2024
Estimated completion	2 December 2026
Sites	194 locations across France, Italy, Japan, Russia, Belgium, United Kingdom, Germany, Poland

Drugs / interventions tested

PF-06801591 (pf-06801591) — full drug profile →
Bacillus Calmette-Guerin

Conditions studied

Non-muscle Invasive Bladder Cancer — all drugs for Non-muscle Invasive Bladder Cancer →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Non-muscle Invasive Bladder Cancer. 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.

Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C Primary · From randomization (Day 1) to first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks)

EFS: time from randomization till recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after complete response (CR) for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive di

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	NA	NA – NA
Cohort A, Arm C: BCG (IND+MNT)	NA	NA – NA

Cohort A: EFS as Assessed by the Investigator: Arm B Versus Arm C Secondary · From randomization (Day 1) to the first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks)

EFS: time from randomization till recurrence of high-grade disease, progression of disease, CIS, death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after CR for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive disease, lymph node positive disease, metastatic disease,

Group	Value	95% CI
Cohort A, Arm B: PF-06801591+BCG (IND)	50.1	47.1 – NA
Cohort A, Arm C: BCG (IND+MNT)	NA	NA – NA

Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set Secondary · From randomization (Day 1) to the first documented CR (maximum follow up duration was up to 257.1 weeks)

CR was defined as histologic disappearance of malignancy on bladder biopsy with negative cytology and cystoscopy or negative cytology and positive cystoscopy with biopsy-proven low-grade stage of bladder cancer defined as a non-invasive papillary carcinoma (Ta) lesion or non-malignant tissue for participants with CIS at randomization. 95% CI was based on Clopper-Pearson method.

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	89.8	81.5 – 95.2
Cohort A, Arm B: PF-06801591+BCG (IND)	88.2	79.8 – 93.9
Cohort A, Arm C: BCG (IND+MNT)	85.2	76.1 – 91.9

Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set Secondary · From date of first documentation of CR to date of an EFS event (maximum follow up duration was up to 257.1 weeks)

Duration of CR was defined as the time from the first documentation of CR to the date of an EFS event for participants with CR. EFS was defined as the time in months from randomization until recurrence of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first. CR was defined as histologic disappearance of malignancy on bladder biopsy with negative cytology and cystoscopy or negative cytology and positive cystoscopy with biopsy-proven low-grade stage of bladder cancer defined as a non-invasive papillary carcinoma (Ta) lesion or non-mal

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	NA	NA – NA
Cohort A, Arm B: PF-06801591+BCG (IND)	44.6	44.6 – NA
Cohort A, Arm C: BCG (IND+MNT)	NA	39.3 – NA

Cohort A: Time to Recurrence of Low-Grade Disease Assessed by the Investigator Secondary · From randomization (Day 1) to the date of positive biopsy, cystoscopy or cytology results (maximum follow up duration was up to 257.1 weeks)

Time to recurrence of low-grade disease was defined as the time from randomization to the date of first documentation of recurrence of low-grade disease. Recurrence of low-grade disease was defined as re-appearance of low-grade disease (low-grade Ta) after randomization based on positive biopsy, cystoscopy or cytology result. Kaplan-Meier method was used. 95% CI was estimated based on Brookmeyer and Crowley method.

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	48.8	NA – NA
Cohort A, Arm B: PF-06801591+BCG (IND)	NA	47.9 – NA
Cohort A, Arm C: BCG (IND+MNT)	NA	NA – NA

Cohort A: Concentration at Trough (Ctrough) of PF-06801591 for Arms A and B Only Secondary · Pre-dose on Day 1 of Cycles 1, 2, 4, 6, 8, 10 and 13 (1 cycle=4 weeks)

Concentration at Trough is defined as Predose/trough concentration Observed directly from data.

Cycle 1 (Day 1)

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	NA	NA – NA
Cohort A, Arm B: PF-06801591+BCG (IND)	NA	NA – NA

Cycle 2 (Day1)

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	17530.0	16848.8 – 18238.8
Cohort A, Arm B: PF-06801591+BCG (IND)	17398.8	16569.0 – 18270.0

Cycle 4 (Day1)

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	30587.9	29256.1 – 31980.4
Cohort A, Arm B: PF-06801591+BCG (IND)	30507.1	29043.6 – 32044.3

Cycle 6 (Day 1)

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	32945.2	31352.8 – 34618.5
Cohort A, Arm B: PF-06801591+BCG (IND)	34614.0	32634.8 – 36713.2

Cycle 8 (Day 1)

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	35701.1	34030.3 – 37454.0
Cohort A, Arm B: PF-06801591+BCG (IND)	36414.1	33579.4 – 39488.1

Cycle 10 (Day 1)

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	38616.9	36395.7 – 40973.6
Cohort A, Arm B: PF-06801591+BCG (IND)	38965.4	36374.5 – 41740.9

Cycle 13 (Day 1)

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	41969.4	39420.4 – 44683.3
Cohort A, Arm B: PF-06801591+BCG (IND)	41737.1	39045.7 – 44614.1

Cohort A: Number of Participants With Positive (Anti-Drug Antibody) ADA or (Neutralizing Antibody) NAb: Arms A and B Only Secondary · From start of study treatment (Day 1) until 7 days after last dose of study treatment (maximum up to 125.1 weeks and 104.4 weeks of treatment exposure for Arm A and Arm B, respectively)

A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-fold dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).

ADA

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	19
Cohort A, Arm B: PF-06801591+BCG (IND)	19

NAb

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	0
Cohort A, Arm B: PF-06801591+BCG (IND)	1

Cohort A: Number of Participants According to Tumor Sample Biomarker Status Based on Baseline Programmed Cell Death Ligand 1 (PD-L1) Expression Secondary · From start of study treatment (Day 1) until 7 days after last dose of study treatment (maximum up to 125.1 weeks, 104.4 weeks and 110 weeks of treatment exposure for Arm A, Arm B and Arm C, respectively)

PD-L1 expression was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and immune cells in regions of interest that were defined by tumor cell morphology. PDL-1 status was high if \>=25% tumor cell or (immune cells present in the tumor area \> 1% and PD-L1 positive immune cells+ \>=25%) or (immune cells present in the tumor area = 1% and PD-L1 positive immune cells = 100%), and low if \< 25% tumor cell and \[(immune cells present in the tumor area \> 1% and immune cells \<25%) or (immune cells present in the tumor area = 1% and PD-L1 positiv

High

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	77
Cohort A, Arm B: PF-06801591+BCG (IND)	68
Cohort A, Arm C: BCG (IND+MNT)	73

Low

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	252
Cohort A, Arm B: PF-06801591+BCG (IND)	256
Cohort A, Arm C: BCG (IND+MNT)	253

Unknown

Group	Value	95% CI
Cohort A, Arm A: PF-06801591+BCG (IND+MNT)	11
Cohort A, Arm B: PF-06801591+BCG (IND)	13
Cohort A, Arm C: BCG (IND+MNT)	11

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy (maximum follow up duration was up to 257.1 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A, Arm A: PF-06801591+BCG (IND+MNT)

Serious: 120/350 (34%)

Deaths: 32/352

Cohort A, Arm B: PF-06801591+BCG (IND)

Serious: 99/348 (28%)

Deaths: 30/352

Cohort A, Arm C: BCG (IND+MNT)

Serious: 49/349 (14%)

Deaths: 29/351

Cohort B1: PF-06801591 300 mg

Serious: 2/5 (40%)

Deaths: 0/5

Cohort B2: PF-06801591 600 mg

Serious: 2/8 (25%)

Deaths: 0/8

Serious adverse events (227 terms)

Reaction	System	Cohort A, Arm A: PF-068015…	Cohort A, Arm B: PF-068015…	Cohort A, Arm C: BCG (IND+…	Cohort B1: PF-06801591 300…	Cohort B2: PF-06801591 600…
Pneumonia	Infections and infestations	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—
Colitis ulcerative	Gastrointestinal disorders	—	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—	—
Type 2 diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—
Myocarditis	Cardiac disorders	—	—	—	—	—
Hypopituitarism	Endocrine disorders	—	—	—	—	—
Large intestine polyp	Gastrointestinal disorders	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—

Other adverse events (80 terms — click to expand)

Reaction	System	Cohort A, Arm A: PF-068015…	Cohort A, Arm B: PF-068015…	Cohort A, Arm C: BCG (IND+…	Cohort B1: PF-06801591 300…	Cohort B2: PF-06801591 600…
Dysuria	Renal and urinary disorders	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—
SARS-CoV-2 test positive	Investigations	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Micturition urgency	Renal and urinary disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Hyperthyroidism	Endocrine disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Weight increased	Investigations	—	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—	—
Cystitis noninfective	Renal and urinary disorders	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—
Nocturia	Renal and urinary disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Blood thyroid stimulating hormone increased	Investigations	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—

Most-reported serious reactions: Pneumonia, COVID-19, Urinary tract infection, Pancreatitis, Sepsis, Arthritis, Acute kidney injury, Anaemia.

Data from ClinicalTrials.gov NCT04165317 adverse events section.

Sponsor's own description

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. * One group is given sasanlimab and BCG at the study clinic. * The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. * The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor. \- Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

Publications & conference data

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

Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Vaccine Therapies for Cancer: Then and Now.
Morse MA, Gwin WR, Mitchell DA. · · 2021 · cited 156× · PMID 33512679 · DOI 10.1007/s11523-020-00788-w
Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
Emerging Trends in Immunotherapy for Cancer.
Mishra AK, Ali A, Dutta S, Banday S, et al · · 2022 · cited 41× · PMID 36135216 · DOI 10.3390/diseases10030060
Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial.
Shore ND, Powles TB, Bedke J, Galsky MD, et al · · 2025 · cited 40× · PMID 40450141 · DOI 10.1038/s41591-025-03738-z
New Perspectives in the Medical Treatment of Non-Muscle-Invasive Bladder Cancer: Immune Checkpoint Inhibitors and Beyond.
Audisio A, Buttigliero C, Delcuratolo MD, Parlagreco E, et al · · 2022 · cited 28× · PMID 35159167 · DOI 10.3390/cells11030357
Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer.
Hannouneh ZA, Hijazi A, Alsaleem AA, Hami S, et al · · 2023 · cited 26× · PMID 38037752 · DOI 10.1002/cam4.6768
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer.
Galsky MD, Balar AV, Black PC, Campbell MT, et al · · 2021 · cited 25× · PMID 34266883 · DOI 10.1136/jitc-2021-002552

Verify or expand the search:

Other trials of PF-06801591

Trials testing the same drug.

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NCT02616185 — A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) · Phase 1 · terminated

Other recruiting trials for Non-muscle Invasive Bladder Cancer

Currently open trials in the same condition.

NCT07206225 — A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer · Phase 1 · recruiting
NCT06503614 — A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT06632964 — A Clinical Trial Aimed at Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder C · Phase 1 · recruiting
NCT07252297 — The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer · NA · active not recruiting
NCT03933826 — CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer · active not recruiting

Other Pfizer trials

Trials by the same sponsor.

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NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

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 NCT04165317 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Pfizer
Last refreshed: 22 January 2026

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/NCT04165317.

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