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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02537444
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : September 12, 2019
Last Update Posted : September 25, 2019
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Acalabrutinib Drug: acalabrutinib and pembrolizumab combination Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer
Actual Study Start Date : November 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Regimen 1
Drug: acalabrutinib monotherapy
Drug: Acalabrutinib
Other Name: ACP-196

Experimental: Regimen 2
Drug: Combination of acalabrutinib and pembrolizumab
Drug: acalabrutinib and pembrolizumab combination

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02537444

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United States, Arizona
Arizona Gynecology Oncology
Tucson, Arizona, United States
United States, Pennsylvania
Jordan Center For Gynecologic Cancer At Penn
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Acerta Pharma BV
Merck Sharp & Dohme Corp.
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Study Director: Acerta Clinical Trials 1-888-292-9613;
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:
Statistical Analysis Plan  [PDF] January 30, 2018
Study Protocol  [PDF] May 17, 2016

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Responsible Party: Acerta Pharma BV Identifier: NCT02537444    
Other Study ID Numbers: ACE-ST-208
First Posted: September 1, 2015    Key Record Dates
Results First Posted: September 12, 2019
Last Update Posted: September 25, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents