Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04856189 · ClinicalTrials.gov registry record · Phase 1
Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 1 study, sponsored by Mamta Parikh.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT04856189: Clinical Trial Phase 1 study, sponsored by Mamta Parikh.
NCT04856189 is a Phase 1 study that was terminated before completion, run by Mamta Parikh. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04856189, a Phase 1 study, was terminated before completion, sponsored by Mamta Parikh.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This phase Ib/II trial finds the best dose of selinexor and its effect with pembrolizumab in treating patients with urothelial carcinoma that are not eligible to receive the chemotherapy drug cisplatin, or have been given cisplatin and the cancer has gotten worse. Patients must also have urothelial carcinoma that has spread locally, near where it started (locally advanced), or has spread to other parts of the body (metastatic). Selinexor may stop the growth of tumor cells by blocking a protein, called XPO1, that is needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving selinexor and pembrolizumab may kill more tumor cells.
Primary Outcome
Defined by dose-limiting toxicity (DLTs). Dose limiting toxicities will be listed according to dose level. Separately by dose level and the expansion cohort (as well as for the total RP2D cohort), adverse events (AEs) will be summarized as number of patients according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 term and grade, where grade is the maximum across a patient's treatment period.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Selinexor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-04-08 |
| Est. Completion | 2024-02-13 |
| Phase | Phase 1 |
Why NCT04856189 stopped before completion
NCT04856189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04856189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04856189 about?
NCT04856189 is a clinical study titled "Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma". This phase Ib/II trial finds the best dose of selinexor and its effect with pembrolizumab in treating patients with urothelial carcinoma that are not eligible to receive the chemotherapy drug cisplatin, or have been given cisplatin and the cancer has gotten worse. Patients must also have urothelial ...
What is the current status of trial NCT04856189?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-04-08. Estimated completion is 2024-02-13.
What interventions are being tested in trial NCT04856189?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Selinexor (DRUG).
Who is sponsoring clinical trial NCT04856189?
This trial is sponsored by Mamta Parikh, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04856189's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI