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Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate

NCT03582475 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-12

Study results available
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Summary

This phase Ib trial studies how well pembrolizumab works with combination chemotherapy in treating participants with small cell/neuroendocrine cancers of the urothelium or prostate that has spread to nearby tissue or lymph nodes or that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as etoposide, docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with platinum-based chemotherapy may work better in treating participants with small cell/neuroendocrine cancers of the urothelium or prostate.

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

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Docetaxel

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

Principal Investigators

  • Arnold Chin · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2025-12-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582475 on ClinicalTrials.gov