## Protocol Section
### Identification Module
**NCT ID:** NCT02454179

**Acronym:** KEYNOTE147

**Brief Title:** Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma

**Official Title:** A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Head and Neck Squamous Cell Carcinoma

#### Organization Study ID Info
**ID:** ACE-ST-006
#### Organization
**Class:** INDUSTRY
**Full Name:** Acerta Pharma BV
### Status Module
#### Completion Date
**Date:** 2018-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-09-12

**Type:** ACTUAL

**Last Update Submit Date:** 2019-08-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-09-12

**Type:** ACTUAL

**Results First Submit Date:** 2019-07-19

**Results First Submit QC Date:** 2019-08-22

#### Start Date
**Date:** 2015-05

**Type:** ACTUAL

**Status Verified Date:** 2019-08

#### Study First Post Date
**Date:** 2015-05-27
**Type:** ESTIMATED
**Study First Submit Date:** 2015-05-22
**Study First Submit QC Date:** 2015-05-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Acerta Pharma BV

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.

### Conditions Module

**Conditions:**

- Squamous Cell Carcinoma of the Head and Neck

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 78

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** pembrolizumab

**Intervention Names:**

- Drug: pembrolizumab

**Label:** Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** acalabrutinib in combination with pembrolizumab

**Intervention Names:**

- Drug: pembrolizumab

- Drug: Acalabrutinib

**Label:** Arm 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1

- Arm 2

**Name:** pembrolizumab

**Other Names:**

- Keytruda

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm 2

**Name:** Acalabrutinib

**Other Names:**

- ACP-196

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.

**Measure:** Number of Participants With Overall Response

**Time Frame:** 52 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Men and women ≥ 18 years of age
* Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
* Presence of radiographically measurable disease as defined by RECIST 1.1
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Prior malignancy (other than HNSCC), 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 metastases and/or carcinomatous meningitis
* A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Health and Science University

**State:** Oregon

#### Overall Officials

**Official 1:**

**Affiliation:** 1-888-292-9613; acertamc@dlss.com

**Name:** Acerta Clinical Trials

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-01-30

- Filename: SAP_000.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 2133372

- Type Abbrev: SAP

- Upload Date: 2019-08-21T16:53

- Date: 2016-01-15

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 4061910

- Type Abbrev: Prot

- Upload Date: 2019-08-22T11:23

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000018307

- Term: Neoplasms, Squamous Cell

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: HIGH

- As Found: Squamous Cell Carcinoma

- ID: M1689

- Name: Squamous Cell Carcinoma of Head and Neck

- Relevance: HIGH

- As Found: Squamous Cell Carcinoma of the Head and Neck

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20451

- Name: Neoplasms, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002294

- Term: Carcinoma, Squamous Cell

- ID: D000077195

- Term: Squamous Cell Carcinoma of Head and Neck

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000092004

- Term: Tyrosine Kinase Inhibitors

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M42185

- Name: Acalabrutinib

- Relevance: HIGH

- As Found: Discontinued

- ID: M349416

- Name: Pembrolizumab

- Relevance: HIGH

- As Found: Blind

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M2889

- Name: Tyrosine Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000582435

- Term: Pembrolizumab

- ID: C000604908

- Term: Acalabrutinib

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Arm 1 - Pembrolizumab

**Deaths Num Affected:** 26

**Deaths Num At Risk:** 39

**Description:** Pembrolizumab Monotherapy

**ID:** EG000

**Other Num Affected:** 39

**Other Num at Risk:** 39

**Serious Number Affected:** 12

**Serious Number At Risk:** 39

**Title:** Arm 1 - Pembrolizumab

**Group ID:** EG001

**Title:** Arm 2 - Acalabrutinib + Pembrolizumab

**Deaths Num Affected:** 23

**Deaths Num At Risk:** 37

**Description:** Acalabrutinib in combination with Pembrolizumab

**ID:** EG001

**Other Num Affected:** 37

**Other Num at Risk:** 37

**Serious Number Affected:** 25

**Serious Number At Risk:** 37

**Title:** Arm 2 - Acalabrutinib + Pembrolizumab

**Frequency Threshold:** 5

#### Other Events

**Term:** Mucosal Inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Seasonal Allergy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** 

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Upper Respiratory Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Candida Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Urinary Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Aptyalism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dry Mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Oedema Peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Non-Cardiac Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and administration site conditions.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Gastrooesophageal Reflux Disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Abdominal Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Oral Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Mouth Haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Sinus Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Hypothyroidism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Vision Blurred

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** White Blood Cell Count Decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Decreased Appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hypocalcaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Oral Candidiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Weight Decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Blood Creatinine Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Alanine Aminotransferase Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Aspartate Aminotransferase Increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Platelet Count Decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Musculoskeletel Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Muscular Weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Musculoskeletal Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Pain in Jaw

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Infected Neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Speech Disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Eating Disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Acute Kidney Injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Nocturia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Productive Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Hypoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Wheezing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Oropharyngeal Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Chronic Obstructive Pulmonary Disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Pneumonia Aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Pruritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Rash Maculo-Papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Swelling Face

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Decubitus Ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** 

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** 

**Term:** Hypercalcaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hyperuricaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Muscle Spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Neck Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Cardiac Failure Congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Atrial Flutter

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Cardio-Respiratory Arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Pulseless Electrical Activity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Mouth Heamorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Oral Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General disorders and administration site conditions.

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 37

**Term:** Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General disorders and administration site conditions.

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Urosepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 37

**Term:** Clostridia Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Clostridium Difficile Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Epiglottistis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Osteomyelitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Spinal Compression Fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Stoma Site Haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Decreased Appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Malnutrition

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Tumour Heaorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Tumour Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Cerebrovascular Accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Hypoxic-Ischaemic Encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Confusional State

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Delusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Acute Kidney Injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 37

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 37

**Term:** Respiratory Failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 37

**Term:** Acute Respiratory Failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Hypnoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Atelectasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Chronic Obstructive Pulmonary Disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Hypercapnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Obstructive Airways Disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Pleural Effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Pulmonary Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Aneurysm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Orthrostatic Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Multiple Organ Dysfunction Syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and Administration Site Conditions

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 39

**Group ID:** EG001

**Num At Risk:** 37

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and Administration Site Conditions

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Oedema Peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** General Disorders and Administration Site Conditions

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Autoimmune Hepatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 37

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 37

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 39

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 37

**Time Frame:** Safety Analysis tracked from 0 day to 2 years.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 39

**Group ID:** BG001

**Value:** 37

**Group ID:** BG002

**Value:** 76

**Units:** Participants

### Group

**ID:** BG000

**Title:** Mono Therapy Arm - Pembrolizumab

**Description:** Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).

### Group

**ID:** BG001

**Title:** Combo Therapy Arm - Acalabrutinib + Pembrolizumab

**Description:** Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.45

**Value:** 62.1

#### Measurement

**Group ID:** BG001

**Spread:** 11.12

**Value:** 61.4

#### Measurement

**Group ID:** BG002

**Spread:** 10.71

**Value:** 61.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 35

#### Measurement

**Group ID:** BG002

**Value:** 69

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 35

#### Measurement

**Group ID:** BG001

**Value:** 35

#### Measurement

**Group ID:** BG002

**Value:** 70

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 37

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 66

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 37

#### Measurement

**Group ID:** BG002

**Value:** 76

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** acertamc@dlss.com
**Organization:** Acerta Pharma, LLC
**Phone:** 1-888-292-9613
**Title:** Priti Patel, MD, Executive Director - Head of Clinical Development
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.

And some of the participants didn't make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed.
**Reporting Status:** POSTED
**Time Frame:** 52 weeks
**Title:** Number of Participants With Overall Response
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
**ID:** OG000
**Title:** Mono Therapy Arm - Pembrolizumab
##### Group
**Description:** Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
**ID:** OG001
**Title:** Combo Therapy Arm - Acalabrutinib and Pembrolizumab
### Participant Flow Module
#### Group
**Description:** Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
**ID:** FG000
**Title:** Mono Therapy of Pembrolizumab Arm 1
#### Group
**Description:** Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W).
**ID:** FG001
**Title:** Combo Therapy Acalabrutinib + Pembrolizumab Arm 2
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 39
##### Milestone
**Type:** Enrolled
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 39
##### Milestone
**Type:** Received Study Medication
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 37
##### Milestone
**Type:** Discontinue Study
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 39
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 39
**Has Results:** True