Trial · NCT02365766
Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects
NCT02365766, Phase 1, Phase 2, Completed, Jason R. Brown; results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects. Trials, record NCT02365766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02365766
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects
- NCT number
- NCT02365766
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Jason R. Brown
- Conditions
- Urothelial Carcinoma, Bladder Cancer
- Interventions
- Pembrolizumab, Gemcitabine, Cisplatin, Consolidative Surgery
- First posted
- 2015-02-19
- Last updated
- 2025-03-18
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Safety of Pembrolizumab in Combination With Gemcitabine-Cisplatin | Up to 4 weeks | Number of patients with experienced Dose-Limiting Toxicities (DLTs) will be monitored as a safety and tolerability of pembrolizumab in combination with gemcitabine and cisplatin . The Pembrolizumab DLT is defined as a drug-related adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) V4 criteria that occurs in the first 4 weeks of treatment of pembrolizumab (C1D8 - C2D14) and meets the DLT definition per protocol. |
| Primary | Rate of Pathologic Muscle Invasive Response (PaIR) | Within 2-7 weeks post last dose of pembrolizumab (up to 6 months) | Pathologic muscle invasion response (PaIR), or ≤ypT1N0M0, rate is assessed from the consolidative surgery (radical cystectomy (RC) / nephroureterectomy (NU) - lymph node dissection (LND)) specimen. |
| Secondary | Relapse-Free Survival (RFS) at 18 Months | 18 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Relapse-Free Survival is defined by the date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs. |
| Secondary | Overall Survival (OS) at 5 Years | 5 years | Determine the Overall survival at 5 years. OS is defined by the date of randomization to date of death from any cause. |
| Secondary | Radical Cystectomy (RC) Rate | Within 2-7 weeks post last dose of pembrolizumab (up to 6 months) | To compare the radical cystectomy (RC) rates in subjects who are cisplatin-eligible with those who are cisplatin-ineligible. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase Ib: Safety of Pembrolizumab in Combination With Gemcitabine-Cisplatin | Up to 4 weeks | All participants in Phase 1b received same dose. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Rate of Pathologic Muscle Invasive Response (PaIR) | Within 2-7 weeks post last dose of pembrolizumab (up to 6 months) | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint PaIR Rate was defined as all Cisplatin-eligible treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2.~38 out of 43 Cisplatin eligible patients and 33 out of 38 Cisplatin ineligible patients had data of pathological response. | Percentage of participants | NUMBER |
| SECONDARY | Relapse-Free Survival (RFS) at 18 Months | 18 months | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Relapse-Free Survival was defined as all Cisplatin-eligible patients treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible patients treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2.~37 out of 38 Cisplatin ineligible patients were evaluable for RFS. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) at 5 Years | 5 years | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall Survival was defined as all Cisplatin-eligible patients treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible patients treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2. | Percentage of participants | NUMBER |
| SECONDARY | Radical Cystectomy (RC) Rate | Within 2-7 weeks post last dose of pembrolizumab (up to 6 months) | In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Radical Cystectomy Rate was defined as all Cisplatin-eligible patients treated at the MTD, which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2 + cisplatin 70mg/m2; and all Cisplatin-ineligible patients treated at the MTD which was determined to be pembrolizumab 200 mg + gemcitabine 1000mg/m2.~37 out of 38 Cisplatin ineligible patients were evaluable for Radical Cystectomy Rate. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase Ib: Safety of Pembrolizumab in Combination With Gemcitabine-Cisplatin | Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg | 0 | Participants | ||
| Rate of Pathologic Muscle Invasive Response (PaIR) | Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 61 | 95% Confidence Interval 46 to 74 | Percentage of participants | |
| Rate of Pathologic Muscle Invasive Response (PaIR) | Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg | 51.5 | 95% Confidence Interval 35 to 68 | Percentage of participants | |
| Relapse-Free Survival (RFS) at 18 Months | Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 83 | 95% Confidence Interval 67 to 91 | Percentage of participants | |
| Relapse-Free Survival (RFS) at 18 Months | Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg | 57.4 | 95% Confidence Interval 40 to 72 | Percentage of participants | |
| Overall Survival (OS) at 5 Years | Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 71.9 | 95% Confidence Interval 55 to 83 | Percentage of participants | |
| Overall Survival (OS) at 5 Years | Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg | 56.6 | 95% Confidence Interval 39 to 71 | Percentage of participants | |
| Radical Cystectomy (RC) Rate | Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 86 | 95% Confidence Interval 73 to 93 | Percentage of participants | |
| Radical Cystectomy (RC) Rate | Cohort II: Cisplatin Ineligible - Pembrolizumab 200 mg | 89 | 95% Confidence Interval 76 to 96 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg | 6 | |
| Overall Study | STARTED | Phase II Cohort I: Cisplatin-eligible- Pembrolizumab 200 mg | 37 | |
| Overall Study | STARTED | Phase II Cohort II: Cisplatin-ineligible -Pembrolizumab 200 mg | 40 | |
| Overall Study | COMPLETED | Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg | 6 | |
| Overall Study | COMPLETED | Phase II Cohort I: Cisplatin-eligible- Pembrolizumab 200 mg | 37 | |
| Overall Study | COMPLETED | Phase II Cohort II: Cisplatin-ineligible -Pembrolizumab 200 mg | 38 | |
| Overall Study | NOT COMPLETED | Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Phase II Cohort I: Cisplatin-eligible- Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Phase II Cohort II: Cisplatin-ineligible -Pembrolizumab 200 mg | 2 |
Source ClinicalTrials.gov
Adverse events708
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 | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 1 | 6 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg | 3 | 37 | 3 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg | 5 | 38 | 9 |
| other | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 1 | 6 | 1 |
| other | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg | 0 | 37 | 0 |
| other | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg | 0 | 38 | 0 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 2 | 6 | 2 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg | 0 | 37 | 0 |
| other | ACUTE KIDNEY INJURY | Renal and urinary disorders | Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg | 2 | 38 | 2 |
| other | ADRENAL INSUFFICIENCY | Endocrine disorders | Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 1 | 6 | 1 |
1 to 10 of 708Source ClinicalTrials.gov
See all 708 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 1 | 6 |
| Total, all-cause mortality | Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg | 11 | 37 |
| Total, all-cause mortality | Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg | 16 | 38 |
| Total, other adverse events | Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 6 | 6 |
| Total, other adverse events | Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg | 37 | 37 |
| Total, other adverse events | Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg | 38 | 38 |
| Total, serious adverse events | Phase 1b Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg | 1 | 6 |
| Total, serious adverse events | Phase II Cohort I: Cisplatin Eligible- Pembrolizumab 200 mg | 17 | 37 |
| Total, serious adverse events | Phase II Cohort II: Cisplatin Ineligible -Pembrolizumab 200 mg | 17 | 38 |
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.
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/NCT02365766
GET https://conductscience.org/api/trials/v1/NCT02365766/events?page=2