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

NCT ID: NCT02537444

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-10-31

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

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen 1

Drug: acalabrutinib monotherapy

Group Type: EXPERIMENTAL

Acalabrutinib

Intervention Type: DRUG

Regimen 2

Drug: Combination of acalabrutinib and pembrolizumab

Group Type: EXPERIMENTAL

acalabrutinib and pembrolizumab combination

Intervention Type: DRUG

Interventions

Acalabrutinib

Intervention Type: DRUG

acalabrutinib and pembrolizumab combination

Intervention Type: DRUG

Other Intervention Names

ACP-196

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Acerta Pharma BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Acerta Clinical Trials

Role: STUDY_DIRECTOR

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

Locations

Arizona Gynecology Oncology

Tucson, Arizona, United States

Jordan Center For Gynecologic Cancer At Penn

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

ACE-ST-208

Identifier Type: -

Identifier Source: org_study_id