NCT02351739

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

January 28, 2015

Results QC Date

July 19, 2019

Last Update Submit

August 22, 2019

Conditions

Metastatic Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Overall Response

    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

    Every 12 weeks for up to 2 years.

Study Arms (2)

Pembrolizumab

OTHER

Arm 1: pembrolizumab monotherapy

Drug: pembrolizumab

ACP-196 in combination with pembrolizumab

OTHER

Arm 2: ACP-196 in combination with pembrolizumab

Drug: ACP-196 in combination with pembrolizumab

Interventions

pembrolizumabDRUG
Pembrolizumab
ACP-196 in combination with pembrolizumabDRUG
ACP-196 in combination with pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Chicago

Chicago, Illinois, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

James Cancer Hospital

Columbus, Ohio, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

pembrolizumabacalabrutinib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Results Point of Contact

Title
Priti Patel, MD, Executive Director - Head of Clinical Development
Organization
Acerta Pharma, LLC
acertamc@dlss.com
1-888-292-9613

Study Officials

  • Acerta Clinical Trials

    1-888-292-9613; acertamc@dlss.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

January 30, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2018

Study Completion

April 1, 2018

Last Updated

September 10, 2019

Results First Posted

September 10, 2019

Record last verified: 2019-08

Locations

US(7)