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

Not Recruiting

Trial ID: NCT02537444


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

Official Title

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

Stanford Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.

Mary Lake Polan Professor

Hans-Christoph Becker, MD, FSABI, FSCCT

Clinical Professor, Radiology


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

   - 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.


drug: Acalabrutinib

drug: acalabrutinib and pembrolizumab combination

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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