Trial · NCT03582475
Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate
NCT03582475, Phase 1, Active not recruiting, Jonsson Comprehensive Cancer Center; results first posted 2025-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate. Trials, record NCT03582475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03582475
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate
- NCT number
- NCT03582475
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Conditions
Bladder Small Cell Neuroendocrine Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Prostate Carcinoma Metastatic in the Bone, Prostate Neuroendocrine Neoplasm, Prostate Small Cell Carcinoma, Stage III Bladder Cancer American Joint Committee on Cancer ( AJCC) v8, Stage III Prostate Cancer AJCC v8, Stage III Urethral Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Stage IVA Bladder Cancer AJCC v8, Stage IVB Bladder Cancer AJCC v8, Ureter Small Cell Carcinoma, Urothelial Carcinoma
- Interventions
- Carboplatin, Cisplatin, Docetaxel, Etoposide, Pembrolizumab
- First posted
- 2018-07-11
- Last updated
- 2025-11-12
- Results first posted
- 2025-06-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Durable Response Rate (DRR) (Cohorts 1 and 2) | At 6 months | Durable Response Rate (DRR) defined as the proportion of patients who achieved a confirmed complete or partial response (CR or PR) and maintained that response for at least 6 months. |
| Primary | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2) | Up to 3 years | Overall Response Rate (ORR) defined as patients by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 exhibited a complete or partial response (CR or PR). CR defined as disappearance of all target lesions. PR defined as \>= 30% decrease in sum of the longest diameter of target lesions. . |
| Primary | Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2) | From the first documented CR or PR up to 3 years | Duration of Response (DOR) defined as the time from the first documented CR or PR until radiograph disease progression or Prostate-Specific Antigen (PSA) progression. |
| Primary | Proportion of Participants With Progression Free Survival at 12 and 24 Months | 12 months and 24 months. | Progression Free Survival (PFS) defined as the time from the first day of study treatment to first documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesion(s). |
| Primary | Proportion of Participants With Overall Survival of Cohort 1 and 2 at 12 and 24 Months | 12 months and 24 months. | Overall Survival (OS) defined as the time from the first day of study treatment to the time of death from any cause. |
| Primary | Portion of Participants With Radiographic Progression-free Survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) at 12 and 24 Months (Cohort 2) | 12 months and 24 months. | PCWG3 is specifically designed for prostate cancer and incorporates both soft tissue and bone response assessment. RECIST 1.1 is used for evaluating responses in solid tumors, while PCWG3 combines Response evaluation criteria in solid tumors (RECIST)1.1 for soft tissue assessment with specific criteria for bone scans. The PCWG3 response criteria was used to report the portion of participants with rPFS at their 12 and 24 month assessments. |
| Primary | Percentage of Participants With Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Cohorts 1 and 2) | Up to 3 years | |
| Other | Percentage of Participants With Programmed Death-ligand 1 (PD-L1) Combined Positive Score (CPS) Greater Than 10, at 12 Months | at 12 months |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Durable Response Rate (DRR) (Cohorts 1 and 2) | At 6 months | one patient withdrew Cohort 2 | percentage of participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2) | Up to 3 years | one patient withdrew Cohort 2 | proportion of participents | NUMBER |
| PRIMARY | Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2) | From the first documented CR or PR up to 3 years | one patient withdrew Cohort 2 | Months | MEDIAN |
| PRIMARY | Proportion of Participants With Progression Free Survival at 12 and 24 Months | 12 months and 24 months. | Proportion of Participants with Progression Free Survival at 12 and 24 Months was measured using sample size of each cohort and incidence of events to provide confidence intervals. | Proportion of patients | NUMBER |
| PRIMARY | Proportion of Participants With Overall Survival of Cohort 1 and 2 at 12 and 24 Months | 12 months and 24 months. | one patient withdrew Cohort 2 | Proportion of patients | NUMBER |
| PRIMARY | Portion of Participants With Radiographic Progression-free Survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) at 12 and 24 Months (Cohort 2) | 12 months and 24 months. | The Primary outcome of Radiographic PFS (rPFS) with response criteria based off Prostate Cancer Working Group 3 (PCWG3) only applies to Prostate cancer patients enrolled into cohort 2. This criteria does not apply to Bladder cancer patients that enrolled in Cohort 1. | proportion of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Cohorts 1 and 2) | Up to 3 years | percentage of participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Programmed Death-ligand 1 (PD-L1) Combined Positive Score (CPS) Greater Than 10, at 12 Months | at 12 months | PD-L1% (defined CPS\>10). combined positive score (CPS). CPS defined as number of PD-L1 staining cells in tumor, lymphocytes, and macrophages divided by total number viable tumor cells x 100. | Percentage of patients with (CPS) > 10 | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Durable Response Rate (DRR) (Cohorts 1 and 2) | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 100 | percentage of participants | ||
| Durable Response Rate (DRR) (Cohorts 1 and 2) | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 66.7 | percentage of participants | ||
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2) | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 0.43 | proportion of participents | ||
| Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2) | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 0.43 | proportion of participents | ||
| Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2) | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | NA | 95% Confidence Interval NA to NA | Months | |
| Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2) | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 12.6 | 95% Confidence Interval 3.15 to NA | Months | |
| Proportion of Participants With Progression Free Survival at 12 and 24 Months | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 12 months | 0.86 | 95% Confidence Interval 0.63 to 1.00 | Proportion of patients |
| Proportion of Participants With Progression Free Survival at 12 and 24 Months | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 12 months | .43 | 95% Confidence Interval 0.18 to 1.00 | Proportion of patients |
| Proportion of Participants With Progression Free Survival at 12 and 24 Months | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 24 months | 0.86 | 95% Confidence Interval 0.63 to 1.00 | Proportion of patients |
| Proportion of Participants With Progression Free Survival at 12 and 24 Months | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 24 months | 0.14 | 95% Confidence Interval 0.02 to 0.88 | Proportion of patients |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 7 | |
| Treatment Period | STARTED | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 8 | |
| Treatment Period | COMPLETED | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 7 | |
| Treatment Period | COMPLETED | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 7 | |
| Treatment Period | NOT COMPLETED | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 0 | |
| Treatment Period | NOT COMPLETED | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 1 | |
| Follow-up Period | STARTED | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 7 | |
| Follow-up Period | STARTED | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 8 | |
| Follow-up Period | COMPLETED | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 7 | |
| Follow-up Period | COMPLETED | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events162
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 | Alopecia | Skin and subcutaneous tissue disorders | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 5 | 7 | 5 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 2 | 8 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 6 | 7 | 12 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 4 | 8 | 5 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 1 | 7 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 2 | 8 | 2 |
| other | Anxiety | Psychiatric disorders | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 1 | 7 | 1 |
| other | Anxiety | Psychiatric disorders | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 0 | 8 | 0 |
| other | B-12 deficiency | Metabolism and nutrition disorders | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 1 | 7 | 1 |
| other | B-12 deficiency | Metabolism and nutrition disorders | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 1 | 8 | 1 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 3 | 7 |
| Total, all-cause mortality | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 3 | 8 |
| Total, other adverse events | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 7 | 7 |
| Total, other adverse events | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 6 | 8 |
| Total, serious adverse events | Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 7 | 7 |
| Total, serious adverse events | Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 7 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39536751 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016042 | Cancer Center Support Grant | TEITELL, MICHAEL A | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer vs Cohort 2: Small Cell or Neuroendocrine Prostate Cancer: deaths from any cause | Trial comparisons |
| Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer vs Cohort 2: Small Cell or Neuroendocrine Prostate Cancer: 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.
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