Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatments acalabrutinib, acalabrutinib and pembrolizumab combination
Phase phase 2
Targets BTK, PD-1
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

Summary

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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Drug: acalabrutinib monotherapy
acalabrutinib ACP-196
(Experimental)
Drug: Combination of acalabrutinib and pembrolizumab
acalabrutinib and pembrolizumab combination

Primary Outcomes

Measure
The overall response rate (ORR) of acalabrutinib monotherapy and in combination with pembrolizumab in patients with recurrent ovarian cancer
time frame: 24 months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.