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CompletedNCT02537444Updated Sep 25, 2019Results posted

Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)

A Phase 2 interventional study of Acalabrutinib and acalabrutinib and pembrolizumab combination in Ovarian Cancer, sponsored by Acerta Pharma BV. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Acerta Pharma BV · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer

02

Conditions studied

  • Ovarian Cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 78 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Acerta Pharma BV is the lead sponsor of 40 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 3 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women ≥ 18 years of age.
  • Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
  • Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane.
  • Platinum-sensitive ovarian cancer defined by recurrence or progression of disease > 6 AND \< 24 months after completion of the most recent platinum-based therapy.
  • Measurable disease as defined by RECIST 1.1.
  • ECOG performance status of 0 or 1.
  • Completion of all therapy for the treatment of cancer 2 weeks before the start of study therapy and recovered.

Exclusion criteria

Exclusion Criteria:

  • Evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first 6 cycles of or \< 6 months after the beginning of first-line platinum based chemotherapy.
  • Evidence of platinum-resistant ovarian cancer defined as recurrence or progression within 6 months after completing the most recent platinum-based therapy.
  • More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.
  • Prior malignancy (other than ovarian 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.
  • Breastfeeding and pregnant.
  • Known central nervous system metastases and/or carcinomatous meningitis.
  • Subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months..
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Regimen 1

    Drug: acalabrutinib monotherapy

    Drug: Acalabrutinib

  • Experimental
    Regimen 2

    Drug: Combination of acalabrutinib and pembrolizumab

    Drug: acalabrutinib and pembrolizumab combination

Interventions

  • DrugAcalabrutinib

    Also known as: ACP-196

  • Drugacalabrutinib and pembrolizumab combination
06

What researchers measure

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

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

07

Results

Posted Sep 12, 2019

Participant flow

Participant flow — Overall Study
MilestoneArm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + Pembrolizumab
Started3939
Enrolled3939
Received study medication3839
Discontinued study3939
Completed00
Not completed3939

Outcome measures

PrimaryNumber 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

Time frame:
Every 12 weeks for up to 2 years.
Reported as:
Count of participants · Participants
Number of Participants With Overall Response
ParticipantsArm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + Pembrolizumab
Number of Participants With Overall Response13

Adverse events

Collected over Safety Analysis tracked from 0 day to 2 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1 - Acalabrutinib Monotherapy16/38 (42.1%)8/38 (21.1%)34/38 (89.5%)
Arm 2 - Acalabrutinib + Pembrolizumab22/39 (56.4%)16/39 (41%)39/39 (100%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventArm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + Pembrolizumab
Small Intestinal ObstructionGastrointestinal disorders1/385/39
Pleural EffusionRespiratory, thoracic and mediastinal disorders3/380/39
Alanine Aminotransferase IncreasedInvestigations1/383/39
Aspartate Aminotransferase IncreasedInvestigations1/383/39
Pericardial EffusionCardiac disorders1/380/39
VomitingGastrointestinal disorders1/380/39
PyrexiaGeneral disorders1/381/39
Non-Cardiac Chest PainGeneral disorders1/380/39
CellulitisInfections and infestations1/380/39
SepsisInfections and infestations1/380/39
Most frequent other events
Showing 10 of 83
Most frequent other events
EventArm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + Pembrolizumab
NauseaGastrointestinal disorders16/3829/39
VomitingGastrointestinal disorders7/3821/39
HeadacheNervous system disorders17/3821/39
FatigueGeneral disorders16/3820/39
DiarrheaGastrointestinal disorders17/3811/39
Abdominal PainGastrointestinal disorders9/3814/39
AnaemiaBlood and lymphatic system disorders2/3812/39
Alanine Aminotransferase IncreasedInvestigations4/3810/39
Decreased AppetiteMetabolism and nutrition disorders9/3810/39
CoughRespiratory, thoracic and mediastinal disorders3/3810/39

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Arm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + PembrolizumabTotal
Mean64.6 ± 11.5264.2 ± 12.7564.4 ± 12.08
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + PembrolizumabTotal
Female383977
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + PembrolizumabTotal
Hispanic or Latino134
Not Hispanic or Latino373673
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + PembrolizumabTotal
American Indian or Alaska Native000
Asian213
Native Hawaiian or Other Pacific Islander000
Black or African American134
White333467
More than one race000
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(participants)Arm 1 - Acalabrutinib MonotherapyArm 2 - Acalabrutinib + PembrolizumabTotal
United States383977
08

Study locations

2 sites
  • Arizona Gynecology Oncology
    Tucson, Arizona, United States
  • Jordan Center For Gynecologic Cancer At Penn
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Study documents

  • Statistical analysis plan · Jan 30, 2018
  • Study protocol · May 17, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02537444
Lead sponsor
Acerta Pharma BV
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 1, 2015
Start date
Nov 2015
Primary completion
Jul 2018
Completion
Oct 2018
Results posted
Sep 12, 2019
Last update
Sep 25, 2019

Study contacts

Acerta Clinical Trials
study director · 1-888-292-9613; acertamc@dlss.com
View the source record on ClinicalTrials.gov ↗

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