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ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer

A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02362048
Acronym
KEYNOTE144
Enrollment
77
Registered
2015-02-12
Start date
2015-05-31
Completion date
2017-03-31
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Cancer

Brief summary

ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer

Interventions

DRUGACP-196
DRUGACP-196 in combination with pembrolizumab

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Acerta Pharma BV
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and women ≥ 18 years of age * ECOG performance status of 0 or 1 * Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic * Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy

Exclusion criteria

* Prior malignancy (other than pancreatic 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 or which will not limit survival to \< 2 years. * Known central nervous system (CNS) metastases and/or carcinomatous meningitis * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction * Breastfeeding or pregnant

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.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

Countries

United States

Participant flow

Participants by arm

ArmCount
Monotherapy Arm
ACP-196 alone ACP-196
35
Combination Arm
ACP-196 in combination with pembrolizumab ACP-196 in combination with pembrolizumab
38
Total73

Baseline characteristics

CharacteristicMonotherapy ArmCombination ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
15 Participants15 Participants30 Participants
Age, Categorical
Between 18 and 65 years
20 Participants23 Participants43 Participants
Age, Continuous62.9 Year
STANDARD_DEVIATION 8.19
61.3 Year
STANDARD_DEVIATION 10.94
62.1 Year
STANDARD_DEVIATION 9.69
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants5 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
34 Participants33 Participants67 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants4 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants3 Participants
Race (NIH/OMB)
White
29 Participants33 Participants62 Participants
Region of Enrollment
United States
35 participants38 participants73 participants
Sex: Female, Male
Female
18 Participants19 Participants37 Participants
Sex: Female, Male
Male
17 Participants19 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
30 / 3534 / 38
other
Total, other adverse events
34 / 3538 / 38
serious
Total, serious adverse events
14 / 3526 / 38

Outcome results

Primary

Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.

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

Time frame: Every 12 weeks for up to 2 years.

Population: All participants with Baseline and at least one post-baseline target lesion measurement.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1 - Acalabrutinib MonotherapyNumber of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.0 Participants
Arm 2- Acalabrutinib+PembrolizumabNumber of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.3 Participants

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026