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

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: acalabrutinib and pembrolizumab combination; Drug: Acalabrutinib

• Registration Number: NCT02537444
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-01
• Study Start: 2015-11
• Primary Completion: 2018-07
• Study Completion: 2018-10
• Results First Submitted: 2019-08-05
• Results First Submitted QC: 2019-08-22
• Status Verified: 2019-09
• Results First Posted: 2019-09-12
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regimen 2	acalabrutinib and pembrolizumab combination	Drug: Combination of acalabrutinib and pembrolizumab
Regimen 1	Acalabrutinib	Drug: acalabrutinib monotherapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Overall Response	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

Trial Locations

Locations (2)

Arizona Gynecology Oncology; 🇺🇸 Tucson, Arizona, United States

Jordan Center For Gynecologic Cancer At Penn; 🇺🇸 Philadelphia, Pennsylvania, United States