Trial · NCT02621151

Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder

NCT02621151, Phase 2, Completed, NYU Langone Health; results first posted 2025-10-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder. Trials, record NCT02621151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02621151

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder
NCT number: NCT02621151
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: NYU Langone Health
Conditions: Muscle-invasive Urothelial Cancer of the Bladder
Interventions: Pembrolizumab, Transurethral Resection of Bladder Tumor, Gemcitabine, External Beam Radiation Therapy
First posted: 2015-12-03
Last updated: 2026-09-30
Results first posted: 2025-10-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival	2 years	Bladder-intact disease-free survival is defined as the time from initiation of protocol therapy until the first occurrence of muscle-invasive bladder cancer recurrence, regional pelvic recurrence, distant metastases, bladder cancer-related death, or cystectomy.
Secondary	Complete Response (CR) Rate	up to 21 weeks	The CR rate is the percentage of patients who have achieved CR. At the completion of protocol therapy, patients undergo standard cystoscopy, exam under anesthesia and transurethral resection of bladder tumor to document pathologic response. CR requires no tumor palpable on bimanual examination under anesthesia, no tumor visible on cystoscopy, negative tumor site biopsy, and negative urine cytology.
Secondary	Percentage of Participants Who Survived at Study Completion	up to 5 years
Secondary	Percentage of Participants Who Achieved Metastasis-free Survival at Study Completion	up to 5 years	Metastasis-free survival is defined as not having developed radiographic distant metastases.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival	2 years	The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.	percentage of participants	NUMBER
SECONDARY	Complete Response (CR) Rate	up to 21 weeks	The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Survived at Study Completion	up to 5 years	The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved Metastasis-free Survival at Study Completion	up to 5 years	The analysis focused on the efficacy cohort and did not include the safety lead-in cohort.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival	Pembrolizumab, Gemcitabine, and RT	60	95% Confidence Interval 45 to 73	percentage of participants
Complete Response (CR) Rate	Pembrolizumab, Gemcitabine, and RT	56		percentage of participants
Percentage of Participants Who Survived at Study Completion	Pembrolizumab, Gemcitabine, and RT	83	95% Confidence Interval 68.9 to 91.1	percentage of participants
Percentage of Participants Who Achieved Metastasis-free Survival at Study Completion	Pembrolizumab, Gemcitabine, and RT	84	95% Confidence Interval 70 to 92	percentage of participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab, Gemcitabine, and RT	60
Overall Study	COMPLETED	Pembrolizumab, Gemcitabine, and RT	54
Overall Study	NOT COMPLETED	Pembrolizumab, Gemcitabine, and RT	6

Source ClinicalTrials.gov

Adverse events150

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Distention	Gastrointestinal disorders	Pembrolizumab, Gemcitabine, and RT	1	54
other	Acute Kidney Injury	Renal and urinary disorders	Pembrolizumab, Gemcitabine, and RT	1	54
other	Alanine Aminotransferace Increased	Investigations	Pembrolizumab, Gemcitabine, and RT	9	54
other	Anemia	Blood and lymphatic system disorders	Pembrolizumab, Gemcitabine, and RT	18	54
other	Anorexia	Metabolism and nutrition disorders	Pembrolizumab, Gemcitabine, and RT	15	54
other	Anxiety	Psychiatric disorders	Pembrolizumab, Gemcitabine, and RT	1	54
other	Arthalgia	Musculoskeletal and connective tissue disorders	Pembrolizumab, Gemcitabine, and RT	5	54
other	Arthritis	Musculoskeletal and connective tissue disorders	Pembrolizumab, Gemcitabine, and RT	1	54
other	Ascites	Gastrointestinal disorders	Pembrolizumab, Gemcitabine, and RT	1	54
other	Edema limbs	General disorders	Pembrolizumab, Gemcitabine, and RT	9	54

1 to 10 of 150Source ClinicalTrials.gov

See all 150 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab, Gemcitabine, and RT	16	54
Total, other adverse events	Pembrolizumab, Gemcitabine, and RT	54	54
Total, serious adverse events	Pembrolizumab, Gemcitabine, and RT	15	54

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02621151

GET https://conductscience.org/api/trials/v1/NCT02621151/events?page=2

API reference For AI assistants