CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200 mg IV day 1 + abraxane 100 mg/m² IV days 1 and 8AI-extracted
Key inclusion· 8
  • ✓Recurrent unresectable locally advanced or metastatic urothelial carcinoma
  • ✓Cisplatin-ineligible or platinum-refractory disease
  • ✓Histologically or cytologically confirmed urothelial carcinoma
  • ✓Measurable disease by RECIST 1.1
Key exclusion· 10
  • ✕Prior exposure to immune-mediated therapy (immunotherapy)
  • ✕History of allogeneic organ transplant requiring ongoing immunosuppression
  • ✕Active or prior autoimmune or inflammatory disorders
  • ✕Immunosuppressive medication within 14 days before treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03240016
NCT03240016Phase 2Completed
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ABLE: Phase II, Single Arm, Two-stage Study of Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer

University of Michigan Rogel Cancer Center·interventional·Posted Aug 4, 2017·Updated Jan 16, 2025

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Abraxane for Urothelial Carcinoma. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer. Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. Subjects may continue to receive the study regimen until they experience disease progression or unacceptable toxicity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartFeb 8, 2018
Primary CompletionJun 23, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.9 years ago

Interventions

Pembrolizumabdrug

200mg IV D1

Abraxanedrug

100mg/m\^2 D1 and D8