Ovarian Cancer
Conditions
Brief summary
To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer
Interventions
DRUGAcalabrutinib
DRUGacalabrutinib and pembrolizumab combination
Sponsors
Merck Sharp & Dohme LLC
Acerta Pharma BV
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Response | Every 12 weeks for up to 2 years. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Acalabrutinib Monotherapy Acalabrutinib 100mg administered orally (PO) twice daily BID. | 38 |
| Arm 2 - Acalabrutinib + Pembrolizumab Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). | 39 |
| Total | 77 |
Baseline characteristics
| Characteristic | Arm 1 - Acalabrutinib Monotherapy | Total | Arm 2 - Acalabrutinib + Pembrolizumab |
|---|---|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 11.52 | 64.4 Years STANDARD_DEVIATION 12.08 | 64.2 Years STANDARD_DEVIATION 12.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 73 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 33 Participants | 67 Participants | 34 Participants |
| Region of Enrollment United States | 38 participants | 77 participants | 39 participants |
| Sex: Female, Male Female | 38 Participants | 77 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 38 | 22 / 39 |
| other Total, other adverse events | 34 / 38 | 39 / 39 |
| serious Total, serious adverse events | 8 / 38 | 16 / 39 |
Outcome results
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
Time frame: Every 12 weeks for up to 2 years.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 - Acalabrutinib Monotherapy | Number of Participants With Overall Response | 1 Participants |
| Arm 2 - Acalabrutinib + Pembrolizumab | Number of Participants With Overall Response | 3 Participants |