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Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT02537444•Acerta Pharma BV

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (2)

Arizona Gynecology Oncology

Tucson, Arizona, United States

Jordan Center For Gynecologic Cancer At Penn

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

November 1, 2015

Primary Completion Date

July 1, 2018

Completion Date

October 1, 2018

Last Updated

September 25, 2019

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Acalabrutinib

DRUG

acalabrutinib and pembrolizumab combination

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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