Metastatic Urothelial CarcinomaPhase 2KEYNOTE143NCT02351739

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

A Phase 2 study testing pembrolizumab and ACP-196 in combination with pembrolizumab in people with Metastatic Urothelial Carcinoma, run by Acerta Pharma BV at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Urothelial Carcinoma
What is being tested?: pembrolizumab and ACP-196 in combination with pembrolizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 7 sitesUnited States
Study dates: Apr 2015to Apr 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University of Michigan
Ann Arbor, Michigan
University of Chicago
Chicago, Illinois
James Cancer Hospital
Columbus, Ohio
Study site
Durham, North Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina
University of Pittsburgh
Pittsburgh, Pennsylvania
Oregon Health and Science University
Portland, Oregon

Other trials in United States

About this study

Official title: Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)

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

Conditions: Metastatic Urothelial Carcinoma
Being tested: pembrolizumab, ACP-196 in combination with pembrolizumab
Medical subject headings: Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pembrolizumabDrug
ACP-196 in combination with pembrolizumabDrug

Study groups in NCT02351739
Study group	Role	What they receive
Pembrolizumab	Other	Arm 1: pembrolizumab monotherapy Receives: Drug: pembrolizumab
ACP-196 in combination with pembrolizumab	Other	Arm 2: ACP-196 in combination with pembrolizumab Receives: Drug: ACP-196 in combination with pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Every 12 weeks for up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Apr 2018

First posted30 Jan 2015 (estimated)
Study startApr 2015
Primary completionFeb 2018
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
More trials run by Acerta Pharma BVThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02351739
Sponsor's protocol ID: ACE-ST-005
Acronym: KEYNOTE143
Status last verified: Aug 2019
First submitted: 28 Jan 2015
Last updated: 10 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 3
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma

All Metastatic Urothelial Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)
ClinicalTrials.gov ID: NCT02351739
Acronym / sponsor ID: KEYNOTE143 / ACE-ST-005
Conditions: Metastatic Urothelial Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Acerta Pharma BVIndustry (pharma, biotech, devices)
Collaborators: Merck Sharp & Dohme LLC
Study start: Apr 2015 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Apr 2018 (actual)
First posted: 30 Jan 2015 (estimated)
Results: Posted 10 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pembrolizumab	Other	Drug: pembrolizumabArm 1: pembrolizumab monotherapy
ACP-196 in combination with pembrolizumab	Other	Drug: ACP-196 in combination with pembrolizumabArm 2: ACP-196 in combination with pembrolizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pembrolizumab	Drug	Pembrolizumab
ACP-196 in combination with pembrolizumab	Drug	ACP-196 in combination with pembrolizumab

Primary outcome

Number of Participants With Overall Response
Time frame: Every 12 weeks for up to 2 years.
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

Results and safety

Results posted to the registry on 10 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Pembrolizumab Monotherapy	38	0
Arm 2- Acalabrutinib+Pembrolizumab	40	0

Primary outcome: Number of Participants With Overall Response

Time frame: Every 12 weeks for up to 2 years.. Count of participants. Unit: Participants

Measure	Pembrolizumab n = 31	ACP-196 in Combination With Pembrolizumab n = 34
Value	9	8

Population analysed: 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.

Adverse events

Time frame: Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 730.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 - Pembrolizumab Monotherapy	15 of 35 (42.9%)	34 of 35 (97.1%)	25 of 35
Arm 2 - Acalabrutinib+Pembrolizumab	23 of 40 (57.5%)	39 of 40 (97.5%)	31 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Urothelial Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 3
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Acerta Clinical Trials study director

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

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pembrolizumab and ACP-196 in combination with pembrolizumab in people with Metastatic Urothelial Carcinoma, run by Acerta Pharma BV at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Overall Response (time frame: Every 12 weeks for up to 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02351739.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.