Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)
This trial is active, not recruiting.
|Treatments||acalabrutinib, acalabrutinib and pembrolizumab combination|
|Sponsor||Acerta Pharma BV|
|Collaborator||Merck Sharp & Dohme Corp.|
|Start date||November 2015|
|End date||December 2017|
|Trial size||76 participants|
|Trial identifier||NCT02537444, ACE-ST-208|
To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Tucson, AZ||Arizona Gynecology Oncology||no longer recruiting|
|Los Angeles, CA||UCLA / Jonsson Comprehensive Cancer Center||no longer recruiting|
|Palo Alto, CA||Stanford Cancer Institute||no longer recruiting|
|Tampa, FL||Moffitt Cancer Center||no longer recruiting|
|Chicago, IL||University of Chicago Comprehensive Cancer Center||no longer recruiting|
|Detroit, MI||Wayne State University / Karmanos Cancer Institute||no longer recruiting|
|Columbus, OH||Ohio State University Comprehensive Cancer Center||no longer recruiting|
|Philadelphia, PA||Jordan Center For Gynecologic Cancer At Penn||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Drug: acalabrutinib monotherapy
Drug: Combination of acalabrutinib and pembrolizumab
The overall response rate (ORR) of acalabrutinib monotherapy and in combination with pembrolizumab in patients with recurrent ovarian cancer
time frame: 24 months
Female participants at least 18 years old.
- 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.
- 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.
|Official title||A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer|
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