Clinical trial · Interventional
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer
Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)
NCT02351739CI-TRIAL-00040502KEYNOTE143completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACP-196 in combination with pembrolizumab | Drug | — | UNRESOLVED |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Pembrolizumab
- description
- Arm 1: pembrolizumab monotherapy
- interventionNames
- Drug: pembrolizumab
- type
- OTHER
- label
- ACP-196 in combination with pembrolizumab
- description
- Arm 2: ACP-196 in combination with pembrolizumab
- interventionNames
- Drug: ACP-196 in combination with pembrolizumab
Primary outcomes (1)
- measure
- Number of Participants With Overall Response
- timeFrame
- Every 12 weeks for up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥ 18 years of age * Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed histology bladder cancer * Metastatic bladder cancer with disease progression on or after platinum-based chemotherapy * Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder, and ureters * Prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma * Presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion that measures ≥ 10 mm \[≥ 15 mm for lymph nodes\] * ECOG performance status of 0 or 1 Exclusion Criteria: * Prior malignancy (other than bladder cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years of which will not limit survival to \< 2 years. * Known central nervous system metastases and/or carcinomatous meningitis * Malabsorption syndrome, disease significantly affecting gastrointestinal function * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
References
Publications (0)
Data not yet available
No reference posted for this study.