## Protocol Section
### Identification Module
**NCT ID:** NCT03290079

**Brief Title:** Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

**Official Title:** Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

#### Organization Study ID Info
**ID:** MCC-19207
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-26

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-26

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-01-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2024-03-26

**Type:** ACTUAL

**Results First Submit Date:** 2024-01-26

**Results First Submit QC Date:** 2024-02-26

#### Start Date
**Date:** 2017-12-15

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2017-09-21
**Type:** ACTUAL
**Study First Submit Date:** 2017-09-19
**Study First Submit QC Date:** 2017-09-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** H. Lee Moffitt Cancer Center and Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to:

* Assess overall radiographic response rate (ORR)
* Assess progression-free survival (PFS)
* Test the safety and tolerability of Pembrolizumab in combination with lenvatinib

### Conditions Module

**Conditions:**

- Neuroendocrine Tumors

- Neuroendocrine Carcinoma

- Neuroendocrine Cancer

**Keywords:**

- well-differentiated neuroendocrine tumors

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Simon 2-stage design

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

**Intervention Names:**

- Drug: Pembrolizumab

- Drug: Lenvatinib

**Label:** Pembrolizumab & Lenvatinib treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pembrolizumab & Lenvatinib treatment

**Description:** 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

**Name:** Pembrolizumab

**Other Names:**

- Keytruda®

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Pembrolizumab & Lenvatinib treatment

**Description:** 20 mg Lenvatinib by mouth every day of each 3 week cycle

**Name:** Lenvatinib

**Other Names:**

- Lenvima®

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Response Evaluation Criteria in Solid Tumors (RECIST) based response rate. Complete Response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

**Measure:** Objective Radiographic Response Rate (ORR)

**Time Frame:** Up to 12 months

#### Secondary Outcomes

**Description:** DOR, defined as the time from first documented evidence of Complete Response (CR) or Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.

**Measure:** Duration of Response (DOR)

**Time Frame:** Up to 12 months

**Description:** PFS, defined as the time from initial treatment to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.

**Measure:** Progression Free Survival (PFS)

**Time Frame:** Up to 12 months

**Description:** OS defined as the time from initial treatment until death from any cause.

**Measure:** Overall Survival (OS)

**Time Frame:** At 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis/Condition for entry into the trial: Metastatic well differentiated neuroendocrine tumors of primary lung, thymic, small bowel and colorectal origin (including unknown primary)
* Evidence of radiographic disease progression with scan documenting progression occurring within 8 months of signing informed consent
* At least two prior lines of systemic treatment. If the only prior line of treatment was adjuvant or neoadjuvant, patient must have completed treatment within 12 months. There is no limit to number of prior therapies.
* Willing and able to provide written informed consent/assent for the trial.
* ≥ 18 years of age on day of signing informed consent.
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Demonstrate adequate organ function and laboratory values. All screening labs should be performed within 14 days of treatment initiation.
* Females of childbearing potential (FOCBP) should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
* FOCBP must agree to use adequate contraception as outlined in study documentation for the course of the through 120 days after the last dose of study medication.
* Male participants of childbearing potential must agree to use an adequate method of contraception as outlined in study documentation, starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion Criteria:

* Poorly differentiated neuroendocrine carcinoma
* Pancreatic neuroendocrine tumor
* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* Known history of active TB (Bacillus Tuberculosis)
* Hypersensitivity to pembrolizumab or any of its excipients.
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. - Note: Potential participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If have received major surgery within 3 weeks, must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
* Serious non-healing wound, ulcer or bone fracture
* Has pre-existing \>/= Grade 3 gastrointestinal (GI) or non-GI fistula
* Has significant cardiovascular impairment within 12 months of the first dose of study drug
* Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Potential participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
* History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
* An active infection requiring systemic therapy.
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
* Has received prior therapy with a tyrosine kinase inhibitor (TKI) (e.g.; sunitinib, pazopanib, cabozantinib)
* Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
* Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical management
* Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic, attacks, DVT within the past 6 months
* Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring.(Treatment with low molecular weight heparin (LMWH) is allowed)
* Marked baseline prolongation of QT/QTc interval (QTc interval ≥ 480 msec) using the Fridericia method (QTc = QT/RR0.33) for QTc analysis
* Clinically significant bleeding within 4 weeks
* Medical need for the continued use of potent inhibitors/inducers of CYP3A4
* Creatinine clearance \<30 mL/min
* Any condition that impairs patient's ability to swallow whole pills or gastrointestinal malabsorption that, in the investigator's opinion, might affect absorption of lenvatinib

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tampa

**Country:** United States

**Facility:** H. Lee Moffitt Cancer Center and Research Institute

**State:** Florida

**Zip:** 33612

#### Overall Officials

**Official 1:**

**Affiliation:** H. Lee Moffitt Cancer Center and Research Institute

**Name:** Jonathan Strosberg, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Moffitt Cancer Center Clinical Trials website

**URL:** https://moffitt.org/clinical-trials-research/

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-12-10

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 843054

- Type Abbrev: Prot_SAP

- Upload Date: 2024-01-24T09:38

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: HIGH

- As Found: Neuroendocrine Tumors

- ID: M20423

- Name: Carcinoma, Neuroendocrine

- Relevance: HIGH

- As Found: Neuroendocrine Carcinoma

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: HIGH

- As Found: Neuroendocrine Tumors

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000018278

- Term: Carcinoma, Neuroendocrine

### 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: 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

### Intervention Browse Module - Browse Leaves

- ID: M349416

- Name: Pembrolizumab

- Relevance: HIGH

- As Found: Blind

- ID: M353738

- Name: Lenvatinib

- Relevance: HIGH

- As Found: Fibrillation

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint 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

### Intervention Browse Module - Meshes

- ID: C000582435

- Term: Pembrolizumab

- ID: C000531958

- Term: Lenvatinib

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2024-02-20

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Pembrolizumab & Lenvatinib Treatment

**Deaths Num Affected:** 6

**Deaths Num At Risk:** 20

**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle

**ID:** EG000

**Other Num Affected:** 20

**Other Num at Risk:** 20

**Serious Number Affected:** 12

**Serious Number At Risk:** 20

**Title:** Pembrolizumab & Lenvatinib Treatment

**Frequency Threshold:** 0

#### Other Events

**Term:** Abdominal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Diarrhea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Mucositis oral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Gastrointestinal disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** mucus in stool

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Gastrointestinal disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** hernia

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Belching

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Bloating

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Dry mouth

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Dyspepsia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Gastritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Gastroesophageal reflux disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Gastrointestinal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hemorrhoids

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Lip pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Lower gastrointestinal hemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Oral hemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Oral pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Rectal hemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Toothache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Fever

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Edema limbs

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Non-cardiac chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Chills

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Flu like symptoms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Facial pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** General disorders and administration site conditions - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Dysgeusia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Lethargy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Paresthesia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Presyncope

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Flushing

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Back pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Flank pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Generalized muscle weakness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Bone pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Muscle cramp

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Muscle weakness lower limb

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Sinus tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Pericardial effusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Sinus bradycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Palpitations

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Atrioventricular block complete

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Atrioventricular block first degree

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Cardiac disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Myocarditis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Weight loss

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Alanine aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Aspartate aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Thyroid stimulating hormone increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Electrocardiogram T wave abnormal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Alkaline phosphatase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Blood bilirubin increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Electrocardiogram QT corrected interval prolonged

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Investigations - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Dyspnea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Epistaxis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Nasal congestion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hoarseness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Sore throat

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Palmar-plantar erythrodysesthesia syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Rash maculo-papular

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Pain of skin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Skin and subcutaneous tissue disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Proteinuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hematuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Urinary frequency

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Urinary incontinence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hypothyroidism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Endocrine disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hyperthyroidism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Infections and infestations - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Kidney infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Otitis externa

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Papulopustular rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Prostate infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Upper respiratory infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Term:** Anorexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hyperglycemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hyperkalemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hypoglycemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Hypokalemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Anxiety

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Confusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Bruising

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Injury, poisoning and procedural complications - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Wound complication

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Eye disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Eye pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Watering eyes

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Irregular menstruation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Reproductive system and breast disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Eosinophilia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Lymph node pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

**Term:** Ear and labyrinth disorders - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Vertigo

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** CTCAE (5.0)

#### Serious Events

**Term:** Kidney Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Lower gastrointestinal hemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Abdominal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Alanine aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Disease Progression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 20

**Num Events:** 3

**Term:** Fever

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 20

**Num Events:** 2

**Term:** Rash maculo-papular

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Infections and infestations - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** COVID-19

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Infections and infestations - Other

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** human metapneumovirus

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Death, NOS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 20

**Num Events:** 2

**Term:** Atrioventricular block complete

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Pericardial effusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 20

**Num Events:** 2

**Term:** Sinus tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 20

**Num Events:** 2

**Term:** Hip pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Hypoglycemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 2

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (5.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Time Frame:** Adverse events were collected from start of treatment to 30 days after cessation of treatment, an average of 8.5 months. Patients were followed for survival only for 12 months.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Units:** Participants

### Group

**ID:** BG000

**Title:** Pembrolizumab & Lenvatinib Treatment

**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 11

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 12

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 15

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

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

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 18

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### 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
**PI Sponsor Employee:** True
### Point of Contact
**Email:** jonathan.strosberg@moffitt.org
**Organization:** Moffitt Cancer Center
**Phone:** 813-745-5553
**Title:** Jonathan Strosberg, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** .03
- **Spread:** 
- **Upper Limit:** .30
- **Value:** .1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.8
- **Spread:** 
- **Upper Limit:** 7.4
- **Value:** 6.5
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.8
- **Spread:** 
- **Upper Limit:** 10.2
- **Value:** 8
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 48.1
- **Spread:** 
- **Upper Limit:** 84.4
- **Value:** 70
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Response Evaluation Criteria in Solid Tumors (RECIST) based response rate. Complete Response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Evaluable participants
**Reporting Status:** POSTED
**Time Frame:** Up to 12 months
**Title:** Objective Radiographic Response Rate (ORR)
**Type:** PRIMARY
**Unit of Measure:** proportion of participants
##### Group
**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
**ID:** OG000
**Title:** Pembrolizumab & Lenvatinib Treatment
#### Outcome Measure 2
**Description:** DOR, defined as the time from first documented evidence of Complete Response (CR) or Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** Evaluable participants
**Reporting Status:** POSTED
**Time Frame:** Up to 12 months
**Title:** Duration of Response (DOR)
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
**ID:** OG000
**Title:** Pembrolizumab & Lenvatinib Treatment
#### Outcome Measure 3
**Description:** PFS, defined as the time from initial treatment to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Up to 12 months
**Title:** Progression Free Survival (PFS)
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
**ID:** OG000
**Title:** Pembrolizumab & Lenvatinib Treatment
#### Outcome Measure 4
**Description:** OS defined as the time from initial treatment until death from any cause.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** At 12 months
**Title:** Overall Survival (OS)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
**ID:** OG000
**Title:** Pembrolizumab & Lenvatinib Treatment
### Participant Flow Module
#### Group
**Description:** Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle
**ID:** FG000
**Title:** Pembrolizumab & Lenvatinib Treatment
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
**Has Results:** True