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

Ovarian Cancer Clinical Trial

Official title:

A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537444
• Other study ID #: ACE-ST-208
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2019
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Acalabrutinib

• acalabrutinib and pembrolizumab combination

Locations

Country	Name	City	State
United States	Jordan Center For Gynecologic Cancer At Penn	Philadelphia	Pennsylvania
United States	Arizona Gynecology Oncology	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Acerta Pharma BV	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Every 12 weeks for up to 2 years.