Clinical trial · Interventional
ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
NCT02362048CI-TRIAL-00040937KEYNOTE144completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACP-196 | Drug | Acalabrutinib | ALIAS |
| ACP-196 in combination with pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Arm 1
- description
- ACP-196 alone
- interventionNames
- Drug: ACP-196
- type
- EXPERIMENTAL
- label
- Experimental: Arm 2
- description
- ACP-196 in combination with pembrolizumab
- interventionNames
- Drug: ACP-196 in combination with pembrolizumab
Primary outcomes (1)
- measure
- Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.
- timeFrame
- Every 12 weeks for up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥ 18 years of age * ECOG performance status of 0 or 1 * Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic * Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy Exclusion Criteria: * Prior malignancy (other than pancreatic 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. * Known central nervous system (CNS) metastases and/or carcinomatous meningitis * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction * Breastfeeding or pregnant
References
Publications (1)
- DERIVEDOverman M, Javle M, Davis RE, Vats P, Kumar-Sinha C, Xiao L, Mettu NB, Parra ER, Benson AB, Lopez CD, Munugalavadla V, Patel P, Tao L, Neelapu S, Maitra A. Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer. J Immunother Cancer. 2020 Feb;8(1):e000587. doi: 10.1136/jitc-2020-000587. PMID 32114502