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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT03582475
Phase
PHASE1
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IV
  • Cisplatin — DRUG
    Given IV
  • Docetaxel — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jan 11, 2019
Status verified
Nov 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab, platinum-based chemotherapy)
    Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising either etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1), or etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Durable Response Rate (DRR) (Cohorts 1 and 2) [ Time Frame: At 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

Related coverage on Hipa.ai

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By condition
Bladder cancer
By specialty
OncologyUrology
By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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