Last reviewed · How we verify
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
Phase 1, PHASE2 trial testing Acalabrutinib in Follicular Lymphoma (FL) in 161 participants. Completed in 27 October 2025.
| Lead sponsor | Acerta Pharma BV |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 161 |
| Start date | 20 February 2015 |
| Primary completion | 14 July 2020 |
| Estimated completion | 27 October 2025 |
| Sites | 19 locations across United States |
Acerta Pharma BV — full company profile →
18 and older, any sex, with Follicular Lymphoma (FL) or CLL. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 160 |
Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 105 |
Number of participants with CTCAE Grade 5 (fatal) adverse events
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 9 |
Study drug-related AEs were those assessed by investigator as related to study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 142 |
The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 66 |
Grade 5 (fatal) AEs assessed by investigator as related to study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 3 |
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 75 |
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 64 |
Grade 5 events were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 9 |
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 34 |
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 30 |
Grade 5 AEs were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Acalabrutinib + Pembrolizumab | 3 |
Time frame: For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Acalabrutinib + Pembrolizu… |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Mental status changes | Psychiatric disorders | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Systemic inflammatory response syndrome | General disorders | — |
| Influenza | Infections and infestations | — |
| Septic shock | Infections and infestations | — |
| Hip fracture | Injury, poisoning and procedural complications | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Syncope | Nervous system disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Acalabrutinib + Pembrolizu… |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Headache | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Pyrexia | General disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Hypotension | Vascular disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Oedema peripheral | General disorders | — |
| Insomnia | Psychiatric disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Contusion | Injury, poisoning and procedural complications | — |
| Aspartate aminotransferase increased | Investigations | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — |
| Night sweats | Skin and subcutaneous tissue disorders | — |
| Asthenia | General disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Sinusitis | Infections and infestations | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Pneumonia, Sepsis, Aspartate aminotransferase increased, Acute kidney injury, Pleural effusion, Gastrointestinal haemorrhage, Alanine aminotransferase increased, Dehydration.
Data from ClinicalTrials.gov NCT02362035 adverse events section.
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02362035.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing