A Phase 2 interventional study of Pembrolizumab in Stage I Bladder Cancer AJCC v8, Stage II Bladder Cancer AJCC v8 and Stage III Bladder Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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Among 40 studies testing pembrolizumab in Urinary Bladder Neoplasms — 14 open to participants now, 21 under way, 5 of them phase 3. pembrolizumab · Urinary Bladder Neoplasms.
Among the 40 studies testing pembrolizumab in Urinary Bladder Neoplasms, this one is the 34th largest by enrollment, is one of 3 that started in 2018, is one of 25 in phase 2, and was the 15th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →14 of the 40 studies testing pembrolizumab in Urinary Bladder Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Fox Chase Cancer Center · Sites in United States
Ages 18+
Astellas Pharma Global Development, Inc. · Sites in United States, Canada, Korea, Republic of and 1 more country
Ages 18+
Astellas Pharma Global Development, Inc. · Sites in United States, Australia, Canada and 9 more countries
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States, Canada
Ages 18+
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
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 →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 27 · Phase 3 8
First in 2014; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 23 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 58 across the 40 interventional studies. Of the 19 that completed or were terminated, 15 (79%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 40 have an industry lead sponsor. The 10 most frequent:
M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
32 studies in Urinary Bladder Neoplasms by M.D. Anderson Cancer Center: 2 open now, 10 under way, none of them phase 3. Of 20 finished, 10 (50%) have results posted.
Among the 32 studies in Urinary Bladder Neoplasms by M.D. Anderson Cancer Center, this one is the 16th largest by enrollment of the 26 interventional ones that give a count, is the only one that started in 2018, is one of 14 in phase 2, and was the 25th registered.
M.D. Anderson Cancer Center’s Urinary Bladder Neoplasms studies by the year they started, since 1994.
8 of the studies testing pembrolizumab in Urinary Bladder Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04241185Phase 3Merck Sharp & Dohme LLCEfficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) | 2027-01-31 |
| NCT04164082National Cancer Institute (NCI)Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer | 2026-12-09 |
| NCT05756569Emory UniversityEnfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology | 2026-12-16 |
| NCT04724018Dana-Farber Cancer InstituteSacituzumab Govitecan Plus EV in Metastatic UC | 2027-02-01 |
| NCT03504163Memorial Sloan Kettering Cancer CenterPembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)] | 2027-04 |
Add all 8 to your calendar (.ics) → With an account.
Among the 40 studies testing pembrolizumab in Urinary Bladder Neoplasms, from their registry updates:
Among M.D. Anderson Cancer Center’s 32 in Urinary Bladder Neoplasms:
This tab as a report to print or save as PDF → With an account.
This phase II trial studies the side effects of pembrolizumab and to see how well it works in treating patients with bladder cancer who are undergoing surgery to remove the bladder. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVE:
I. To characterize the safety profile of pembrolizumab in patients with urothelial carcinoma undergoing radical cystectomy.
SECONDARY OBJECTIVES:
I. To explore a signal of anti-cancer immunological activity by evaluating surgical specimens for evidence of post-treatment lymphocytic infiltration and residual tumor compared to pre-treatment biopsy samples.
II. To explore a signal of biomarker activity by evaluating surgical specimens and blood samples for established and not-so-established markers of response to pembrolizumab.
III. To report the tumor yield and sufficiency of tumor for immunological and biomarker activity.
IV. To examine the interaction of the human microbiome and pathologic response to pembrolizumab.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
After completion of study treatment, patients are followed up to 30 and 90 days.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
Biological: Pembrolizumab
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Toxicity for Safety Monitoring (TOX)
The primary endpoint is a joint endpoint classifying patients as having a toxicity of concern (TOX), defined as the presence of any of these: 1) any 30-day grade 3 or higher surgical complication at least possibly related to the treatment, 2) any toxicity at least possibly related to the treatment that prevents surgery, or 3) death between the start of the study and the 30-day post-surgical assessment as long as it is at least possibly related to pembrolizumab or surgery.
Time frame: From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months
Efficacy Endpoint
To explore anti-cancer immunological activity by evaluating surgical specimens for evidence of post-treatment and residual tumor compared to pre-treatment biopsy samples. The main mechanism for doing so will be via histopathologic review of the radical cystectomy specimen. MIBC participants are defined as responders if they achieve a pT1 stage or less. In the case of NMIBC a pT0 status will be used to identify complete response.
Time frame: Efficacy endpoint will be measured at time of surgery
23 participants consented, 6 screen failed. 18 participants were found eligible to receive study treatment. 16 out of the 18 were able to undergo surgery.
| Milestone | Pembrolizumab |
|---|---|
| Started | 18 |
| Completed | 16 |
| Not completed | 2 |
| Withdrew: Death | 1 |
| Withdrew: Toxicity precluding surgery | 1 |
The primary endpoint is a joint endpoint classifying patients as having a toxicity of concern (TOX), defined as the presence of any of these: 1) any 30-day grade 3 or higher surgical complication at least possibly related to the treatment, 2) any toxicity at least possibly related to the treatment that prevents surgery, or 3) death between the start of the study and the 30-day post-surgical assessment as long as it is at least possibly related to pembrolizumab or surgery.
| percentage of participants | Pembrolizumab |
|---|---|
| Toxicity for Safety Monitoring (TOX) | 15 (3 to 33) |
To explore anti-cancer immunological activity by evaluating surgical specimens for evidence of post-treatment and residual tumor compared to pre-treatment biopsy samples. The main mechanism for doing so will be via histopathologic review of the radical cystectomy specimen. MIBC participants are defined as responders if they achieve a pT1 stage or less. In the case of NMIBC a pT0 status will be used to identify complete response.
| Participants | Pembrolizumab |
|---|---|
| Efficacy Endpoint | 5 |
Collected over From initiation of pembrolizumab, until 90 days post-surgery, up to a maximum of 5.5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab | 1/18 (5.6%) | 9/18 (50%) | 17/18 (94.4%) |
| Event | Pembrolizumab |
|---|---|
| Thromboemolic EventVascular disorders | 3/18 |
| Nausea/VomitingGastrointestinal disorders | 2/18 |
| Pelvic InfectionInfections and infestations | 2/18 |
| UTIRenal and urinary disorders | 2/18 |
| Lung InfectionRespiratory, thoracic and mediastinal disorders | 2/18 |
| AnorexiaGastrointestinal disorders | 2/18 |
| DehydrationMetabolism and nutrition disorders | 2/18 |
| SepsisInfections and infestations | 1/18 |
| MyocarditisCardiac disorders | 1/18 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/18 |
| Event | Pembrolizumab |
|---|---|
| AnemiaBlood and lymphatic system disorders | 14/18 |
| FatigueGeneral disorders | 9/18 |
| HyponatremiaInvestigations | 7/18 |
| Creatinine IncreasedRenal and urinary disorders | 4/18 |
| HypokalemiaInvestigations | 3/18 |
| ALT IncreasedInvestigations | 3/18 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/18 |
| Nausea/VomitingGastrointestinal disorders | 3/18 |
| UTIRenal and urinary disorders | 3/18 |
| PruritusSkin and subcutaneous tissue disorders | 3/18 |
| Age, Categorical(Participants) | Pembrolizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 9 |
| Sex: Female, Male(Participants) | Pembrolizumab |
|---|---|
| Female | 4 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 16 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Pembrolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Pembrolizumab |
|---|---|
| United States | 18 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in May 2023, 63 months.
Results were first posted in Jun 2024, 1 year 1 month after primary completion.
Of 155 non-industry phase 2 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 103. This study's 63 months is close to that.
Counting every sponsor, half of 194 studies reached it within 52 months; a quarter within 36 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pembrolizumab