A Phase 1 interventional study of PF-08046876 and Pembrolizumab in Advanced/Metastatic Solid Tumors, Bladder Cancer and Urothelial Carcinoma, sponsored by Pfizer. Recruiting at 31 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
Among 15 studies in Urinary Bladder Neoplasms by Pfizer — 4 open to participants now, 5 under way, 1 of them phase 3. Urinary Bladder Neoplasms · Pfizer.
Among the 15 studies in Urinary Bladder Neoplasms by Pfizer, this one is the 3rd largest by planned enrollment of the 11 interventional ones, is one of 2 that started in 2025, is one of 6 in phase 1, and was the 12th registered.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 540 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →4 of the 15 studies in Urinary Bladder Neoplasms by Pfizer are open now, in 11 countries. Each count lists the studies.
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2025.
Median enrollment 174 across the 11 interventional studies, 373 across the 4 observational. Of the 9 that completed or were terminated, 6 (67%) have results posted.
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
1 of the studies in Urinary Bladder Neoplasms by Pfizer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07897669PfizerA Real-world Study to Learn About of the Characteristics and Outcomes of Advanced or Metastatic Bladder Cancer Patients With Different Histologies | 2027-04-01 |
Among the 15 studies in Urinary Bladder Neoplasms by Pfizer, from their registry updates:
The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.
The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.
The criteria were revised on the registry on Oct 1, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Different groups of participants will receive different doses and/or schedules of the study drug
Drug: PF-08046876
Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Drug: PF-08046876
Participants will be enrolled to 2 dosing regimens deemed to be safe in Part 1
Drug: PF-08046876
Participants with advanced non-small cell lung cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab
Drug: PF-08046876 · Combination Product: Pembrolizumab
Participants with advanced non-small cell lung cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab and carboplatin
Drug: PF-08046876 · Combination Product: Pembrolizumab · Combination Product: Carboplatin
Participants with advanced urothelial cancer that has progressed after 1 to 2 prior lines of treatment in the metastatic/recurrent setting will receive PF-08046876 together with cisplatin
Drug: PF-08046876 · Combination Product: Cisplatin
Participants with advanced urothelial cancer that has progressed after 1 to 2 prior lines of treatment in the metastatic/recurrent setting will receive PF-08046876 together with carboplatin
Drug: PF-08046876 · Combination Product: Carboplatin
Participants with advanced urothelial cancer who have not received treatment in the metastatic/recurrent setting will receive PF-08046876 together with pembrolizumab
Drug: PF-08046876 · Combination Product: Pembrolizumab
Intravenous administration
Intravenous administration
Intravenous administration
Intravenous administration
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.
Time frame: Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy
Occurrence of DLTs as defined by the protocol
Time frame: Baseline to end of DLT evaluation period
Part 1: Recommended Monotherapy Dose for Expansion
RDE will be based on cumulative safety, preliminary anti-tumor activity and pharmacokinetics findings
Time frame: Baseline to 30 days post last study drug administration
Part 2: Recommended Monotherapy Phase 2 Dose
RP2D will be determined based on the cumulative safety, preliminary anti-tumor activity, and pharmacokinetics findings.
Time frame: Baseline to 30 days post last study drug administration
Part 3: Recommended Combination Phase 2 Dose/ Recommended Combination Dose for Expansion
RP2D/RDE will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.
Time frame: Baseline to 30 days post last study drug administration
Objective Response Rate (ORR)
ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Time frame: Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Duration of Response (DOR)
DOR as defined per RECIST 1.1.
Time frame: From the date of the first objective response to the date of disease progression or death (approximately 2 years)
Progression Free Survival (PFS)
PFS as defined per RECIST 1.1.
Time frame: From Baseline to date of first disease progression or death (approximately 2 Years)
Overall Survival (OS)
OS defined as the time until death due to any cause.
Time frame: From baseline to up to 3 years
Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax)
Evaluate the single and multiple dose PK of PF-08048676.
Time frame: Baseline to approximately 30 days after last dose of study drug
PK: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Evaluate the single and multiple dose PK of PF-08048676.
Time frame: Baseline to approximately 30 days after last dose of study drug
PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)
Evaluate the single and multiple dose PK of PF-08048676.
Time frame: Baseline to approximately 30 days after last dose of study drug
Incidence of Anti-Drug Antibody (ADA)
To evaluate the immunogenicity of PF-08046876.
Time frame: Baseline to approximately 30 days after last dose of study drug
Incidence of Neutralizing Antibodies (NAb)
To evaluate the immunogenicity of PF-08046876.
Time frame: Baseline to approximately 30 days after last dose of study drug
Percent change of immune cells within tumors based on multiplex immunofluorescence
This measure will assess changes in the presence or activation of immune cells in the tumor microenvironment using RNA and/or Immunohistochemistry (IHC) assays.
Time frame: Baseline through 4-7 weeks after first dose of study drug
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Started Aug 2025 (actual). Primary completion is estimated for Jul 2028, 34 months after the start.
Of 80 industry-sponsored phase 1 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 66. This study's planned 34 months is below that.
Counting every sponsor, half of 145 studies reached it within 43 months; a quarter within 29 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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