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

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ClinicalTrials.gov Identifier: NCT02537444
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : September 12, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE August 28, 2015
First Posted Date  ICMJE September 1, 2015
Results First Submitted Date  ICMJE August 5, 2019
Results First Posted Date  ICMJE September 12, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
The overall response rate (ORR) of ACP-196 monotherapy and in combination with Pembrolizumab in patients with recurrent ovarian cancer [ Time Frame: 24 months ]
Change History Complete list of historical versions of study NCT02537444 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)
Official Title  ICMJE A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Acalabrutinib
    Other Name: ACP-196
  • Drug: acalabrutinib and pembrolizumab combination
Study Arms  ICMJE
  • Experimental: Regimen 1
    Drug: acalabrutinib monotherapy
    Intervention: Drug: Acalabrutinib
  • Experimental: Regimen 2
    Drug: Combination of acalabrutinib and pembrolizumab
    Intervention: Drug: acalabrutinib and pembrolizumab combination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2019)
78
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)
76
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537444
Other Study ID Numbers  ICMJE ACE-ST-208
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
PRS Account Acerta Pharma BV
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP