Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Pembrolizumab

Immunomodulating Agents

Acalabrutinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Arm 2: ACP-196 in combination with pembrolizumab

pembrolizumab

ACP-196 in combination with pembrolizumab

Acerta Clinical Trials

Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer

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)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Merck Sharp & Dohme LLC

Acerta Pharma BV

Arm 1: Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Arm 1 - Pembrolizumab Monotherapy

Arm 2: Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Arm 2 - Acalabrutinib+Pembrolizumab

Arm 1: pembrolizumab monotherapy

pembrolizumab

Arm 2: ACP-196 in combination with pembrolizumab

ACP-196 in combination with pembrolizumab

ACP-196 in Combination With Pembrolizumab

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Priti Patel, MD, Executive Director - Head of Clinical Development

The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.

And some of the participants didn't make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed.

Number of Participants With Overall Response

Arm 1: Pembrolizumab 200mg Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Arm 1: Pembrolizumab Monotherapy

Arm 2- Acalabrutinib+Pembrolizumab

Overall Study

Spots Global Cancer Trial Database for Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial