Trial · NCT02324582
MK-3475/BCG in High Risk Superficial Bladder Cancer
NCT02324582, Phase 1, Completed, Southern Illinois University; results first posted 2024-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MK-3475/BCG in High Risk Superficial Bladder Cancer. Trials, record NCT02324582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02324582
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK-3475/BCG in High Risk Superficial Bladder Cancer
- NCT number
- NCT02324582
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Southern Illinois University
- Conditions
- Bladder Cancer
- Interventions
- Intravenous MK-3475/ Intravesical BCG
- First posted
- 2014-12-24
- Last updated
- 2024-09-03
- Results first posted
- 2024-09-03
- Limitations and caveats
- The study is limited by the small number of subjects treated and evaluated which did allow for statistical analysis.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events | change from baseline to 23 weeks | Grade and quantity of treatment related adverse events. Due to the small sampling of subjects, no statistical analysis will be performed. Descriptive statistics in the form of counts calculated as percentages will be reported. |
| Secondary | Number of Participants Without Bladder Tumors Upon Cystoscopy Following Treatment. | 19 weeks | Complete response rate per cystoscopy assessment of the bladder at 19 weeks from start of treatment with MK-3475 (pembrolizumab) at week 1.Subjects presenting at Week 19 with a bladder free of tumors upon cystoscopy and without local or metastatic spread were considered a complete response.. Suspicious lesions would be biopsied and sent for confirmation of pathology. Due to the small sampling of subjects, no statistical analysis will be performed. Descriptive statistics in the form of counts calculated as percentages will be reported. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events | change from baseline to 23 weeks | Thirteen patients were dosed (3 with 100mg MK3475 and 10 with 200 mg MK-3475) with a combination of MK-3475 (pembrolizumab) and BCG. All patients were evaluated for Grade 3 and higher adverse events considered related or possibly related to the addition of pembrolizumab to the treatment regimen. Due to the small sampling of subjects, no statistical analysis will be performed. Descriptive statistics in the form of counts calculated as percentages will be reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Without Bladder Tumors Upon Cystoscopy Following Treatment. | 19 weeks | Subjects presenting at Week 19 for cystoscopy with a bladder free of tumors or local or metastatic spread would be considered a complete response. Suspicious lesions would be biopsied and sent for confirmation of pathology. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events | Intravenous MK-3475-100 mg/ Intravesical BCG | Number of Subjects with Grade 3, 4, or 5 treatment related adverse event(s) | 0 | Participants | |
| Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events | Intravenous MK-3475-200 mg/ Intravesical BCG | Number of Subjects with Grade 3, 4, or 5 treatment related adverse event(s) | 4 | Participants | |
| Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events | Intravenous MK-3475-100 mg/ Intravesical BCG | Number of Subjects without a Grade 3, 4, or 5treatment related adverse event(s) | 3 | Participants | |
| Number of Participants With Grade 3, 4, and 5 Treatment Related Adverse Events | Intravenous MK-3475-200 mg/ Intravesical BCG | Number of Subjects without a Grade 3, 4, or 5treatment related adverse event(s) | 6 | Participants | |
| Number of Participants Without Bladder Tumors Upon Cystoscopy Following Treatment. | Intravenous MK-3475-100 mg/ Intravesical BCG | 2 | Participants | ||
| Number of Participants Without Bladder Tumors Upon Cystoscopy Following Treatment. | Intravenous MK-3475-200 mg/ Intravesical BCG | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravenous MK-3475-100 mg/ Intravesical BCG | 3 | |
| Overall Study | STARTED | Intravenous MK-3475-200 mg/ Intravesical BCG | 15 | |
| Overall Study | COMPLETED | Intravenous MK-3475-100 mg/ Intravesical BCG | 3 | |
| Overall Study | COMPLETED | Intravenous MK-3475-200 mg/ Intravesical BCG | 10 | |
| Overall Study | NOT COMPLETED | Intravenous MK-3475-100 mg/ Intravesical BCG | 0 | |
| Overall Study | NOT COMPLETED | Intravenous MK-3475-200 mg/ Intravesical BCG | 5 |
Source ClinicalTrials.gov
Adverse events140
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 | elevated Blood Urea Nitrogen (BUN) | Investigations | Intravenous MK-3475-100 mg/ Intravesical BCG | 1 | 3 | 1 |
| other | elevated Blood Urea Nitrogen (BUN) | Investigations | Intravenous MK-3475-200 mg/ Intravesical BCG | 1 | 10 | 1 |
| other | abdominal pain | Gastrointestinal disorders | Intravenous MK-3475-100 mg/ Intravesical BCG | 0 | 3 | 0 |
| other | abdominal pain | Gastrointestinal disorders | Intravenous MK-3475-200 mg/ Intravesical BCG | 2 | 10 | 2 |
| other | allergic rhinitis | General disorders | Intravenous MK-3475-100 mg/ Intravesical BCG | 1 | 3 | 1 |
| other | allergic rhinitis | General disorders | Intravenous MK-3475-200 mg/ Intravesical BCG | 1 | 10 | 1 |
| other | anemia | Blood and lymphatic system disorders | Intravenous MK-3475-100 mg/ Intravesical BCG | 1 | 3 | 1 |
| other | anemia | Blood and lymphatic system disorders | Intravenous MK-3475-200 mg/ Intravesical BCG | 0 | 10 | 0 |
| other | anorexia | Metabolism and nutrition disorders | Intravenous MK-3475-100 mg/ Intravesical BCG | 1 | 3 | 1 |
| other | anorexia | Metabolism and nutrition disorders | Intravenous MK-3475-200 mg/ Intravesical BCG | 1 | 10 | 1 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravenous MK-3475-100 mg/ Intravesical BCG | 0 | 3 |
| Total, all-cause mortality | Intravenous MK-3475-200 mg/ Intravesical BCG | 3 | 10 |
| Total, other adverse events | Intravenous MK-3475-100 mg/ Intravesical BCG | 3 | 3 |
| Total, other adverse events | Intravenous MK-3475-200 mg/ Intravesical BCG | 10 | 10 |
| Total, serious adverse events | Intravenous MK-3475-100 mg/ Intravesical BCG | 0 | 3 |
| Total, serious adverse events | Intravenous MK-3475-200 mg/ Intravesical BCG | 6 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31320352 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intravenous MK-3475-100 mg/ Intravesical BCG vs Intravenous MK-3475-200 mg/ Intravesical BCG: Number of Participants Without Bladder Tumors Upon Cystoscopy Following Treatment. | Trial comparisons |
| Intravenous MK-3475-100 mg/ Intravesical BCG vs Intravenous MK-3475-200 mg/ Intravesical BCG: deaths from any cause | Trial comparisons |
| Intravenous MK-3475-100 mg/ Intravesical BCG vs Intravenous MK-3475-200 mg/ Intravesical BCG: serious adverse events | Trial comparisons |
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/NCT02324582
GET https://conductscience.org/api/trials/v1/NCT02324582/events?page=2