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PD-1 Inhibitor
Lenvatinib + Pembrolizumab for Colorectal Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days prior to randomization
Has measurable disease per RECIST 1.1 assessed by the investigator Has provided to a designated central laboratory an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion which has not been previously irradiated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 22 months
Awards & highlights
Study Summary
This trial is testing whether a new combination therapy of lenvatinib and pembrolizumab is better than the standard of care for metastatic colorectal cancer in terms of overall survival.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that's not microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). They must have tried standard treatments without success and be able to swallow pills. Participants need a life expectancy of at least 3 months, stable blood pressure, and an ECOG performance status of 0-1. Women must use effective contraception or not be of childbearing potential; men also agree to contraception.Check my eligibility
What is being tested?
The study tests if lenvatinib combined with pembrolizumab improves survival in metastatic colorectal cancer compared to the standard care drugs regorafenib and TAS-102. It aims to prove this combination leads to longer lives for patients who've already tried other treatments.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, diarrhea, decreased appetite, weight loss, joint/muscle pain, hypertension, proteinuria (high levels of protein in urine), thyroid dysfunction and palmar-plantar erythrodysesthesia syndrome ('hand-foot' syndrome).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer can be measured and I can provide a tissue sample that hasn't been treated with radiation.
Select...
I have provided a sample of my tumor that hasn't been treated with radiation to a lab.
Select...
My colorectal cancer is advanced and cannot be surgically removed, and it is not MSI-H/dMMR.
Select...
I can take medicine in pill form or through a feeding tube.
Select...
My cancer progressed after standard treatments, including specific drugs if they were available and suitable for my cancer type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 22 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 22 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change From Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Change From Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
+10 moreSide effects data
From 2021 Phase 2 trial • 41 Patients • NCT0291578371%
Fatigue
58%
Nausea
58%
Diarrhoea
55%
Decreased appetite
52%
Vomiting
39%
Stomatitis
39%
Weight decreased
32%
Hypertension
29%
Abdominal pain
29%
Proteinuria
29%
Dyspnoea
26%
Insomnia
26%
Arthralgia
26%
Headache
26%
Epistaxis
23%
Dysphonia
23%
Anxiety
19%
Dyspepsia
19%
Cough
19%
Nasal congestion
19%
Hypothyroidism
19%
Constipation
19%
Blood creatinine increased
19%
Back pain
16%
Oedema peripheral
16%
Pain in extremity
16%
Pruritus
16%
Muscular weakness
16%
Musculoskeletal chest pain
13%
Gastrooesophageal reflux disease
13%
Dry mouth
13%
Oropharyngeal pain
13%
Anaemia
13%
Sinusitis
13%
Hypertriglyceridaemia
13%
Hypotension
13%
Hypomagnesaemia
13%
Palmar-plantar erythrodysaesthesia syndrome
13%
Toothache
13%
Oral pain
13%
Abdominal pain upper
13%
Asthenia
13%
Dizziness
13%
Dysgeusia
13%
Platelet count decreased
13%
Dehydration
13%
Hyperglycaemia
10%
Thrombocytopenia
10%
Eye swelling
10%
Pain
10%
Urinary tract infection
10%
Influenza like illness
10%
Fall
10%
Alanine aminotransferase increased
10%
Peripheral sensory neuropathy
10%
Pneumonitis
10%
Rash
10%
Productive cough
10%
Haematuria
10%
Dermatitis acneiform
10%
Peripheral swelling
10%
Depression
10%
Blood cholesterol increased
10%
Malignant neoplasm progression
10%
Sinus congestion
10%
Alopecia
10%
Blood triglycerides increased
10%
Lipase increased
6%
Non-cardiac chest pain
6%
Pneumonia
6%
Cancer pain
6%
Bone pain
6%
Abdominal discomfort
6%
Flatulence
6%
Hiccups
6%
Nasopharyngitis
6%
Upper respiratory tract infection
6%
Folliculitis
6%
Gastroenteritis viral
6%
Rib fracture
6%
Taste disorder
6%
Contusion
6%
Hyponatraemia
6%
Dry skin
6%
Acute kidney injury
6%
Skin exfoliation
6%
Swelling face
6%
Nocturia
6%
Rash maculo-papular
6%
Dysuria
6%
Pollakiuria
6%
Bronchitis
6%
Tremor
6%
Palpitations
6%
Chills
6%
Aspartate aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Hypophosphataemia
6%
Musculoskeletal pain
6%
Myalgia
6%
Urinary retention
6%
Upper-airway cough syndrome
6%
Hyperkalaemia
3%
Upper gastrointestinal haemorrhage
3%
Angina pectoris
3%
Atrial tachycardia
3%
Haematochezia
3%
Cerebrovascular accident
3%
Dry eye
3%
Lower gastrointestinal haemorrhage
3%
Pyrexia
3%
International normalised ratio increased
3%
Hepatic encephalopathy
3%
Tinnitus
3%
Pleuritic pain
3%
Abdominal distension
3%
Intestinal obstruction
3%
Hyperthyroidism
3%
Malignant ascites
3%
Sepsis
3%
Lip pain
3%
Tooth abscess
3%
Memory impairment
3%
Vision blurred
3%
Atrial fibrillation
3%
Abdominal pain lower
3%
Accidental overdose
3%
Odynophagia
3%
Skin abrasion
3%
Eye infection
3%
Respiratory syncytial virus infection
3%
Hypokalaemia
3%
Joint stiffness
3%
Nail disorder
3%
Infection
3%
Furuncle
3%
Amylase increased
3%
Aspartate aminotransferase abnormal
3%
Blood potassium decreased
3%
Blister
3%
Haemoptysis
3%
Neck pain
3%
Radicular pain
3%
Hot flush
3%
Flushing
3%
Rash macular
3%
Sciatica
3%
Hallucination
3%
Pruritus generalised
3%
Sensitive skin
3%
Vaginal discharge
3%
Bronchiectasis
3%
Pulmonary pain
3%
Hyperkeratosis
3%
Lipids increased
3%
Skin toxicity
3%
Skin ulcer
3%
Vena cava thrombosis
3%
Abdominal tenderness
3%
Cardiac failure congestive
3%
Hypoacusis
3%
Oral dysaesthesia
3%
Retching
3%
Portal vein thrombosis
3%
Ear infection
3%
Ulnar nerve palsy
3%
Confusional state
3%
Joint swelling
3%
Limb discomfort
3%
Tumour pain
3%
Balance disorder
3%
Cardiac failure
3%
Cyanosis
3%
Stress cardiomyopathy
3%
External ear pain
3%
Anal fissure
3%
Glossodynia
3%
Chest discomfort
3%
Crepitations
3%
Facial pain
3%
Blood lactate dehydrogenase increased
3%
Muscle spasms
3%
Malignant pleural effusion
3%
Melanocytic naevus
3%
Carpal tunnel syndrome
3%
Cerebral haematoma
3%
Dizziness postural
3%
Hypoaesthesia
3%
Irregular sleep wake rhythm disorder
3%
Renal pain
3%
Benign prostatic hyperplasia
3%
Respiration abnormal
3%
Respiratory tract congestion
3%
Rhinorrhoea
3%
Throat irritation
3%
Jugular vein thrombosis
3%
Cold sweat
3%
Gastrointestinal toxicity
3%
Asymptomatic bacteriuria
3%
Impetigo
3%
Injection site abscess
3%
Tooth infection
3%
Cardiac arrest
3%
Faecaloma
3%
Gastric ulcer
3%
Blood thyroid stimulating hormone decreased
3%
Blood thyroid stimulating hormone increased
3%
Blood urea increased
3%
Heart sounds abnormal
3%
Neutrophil count decreased
3%
Platelet count increased
3%
Specific gravity urine increased
3%
Vitamin D decreased
3%
Fluid retention
3%
Hypercalcaemia
3%
Hypercholesterolaemia
3%
Hypernatraemia
3%
White blood cell count decreased
3%
Hypoglycaemia
3%
Deep vein thrombosis
3%
Pleural effusion
3%
Paraesthesia
3%
Groin pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: lenvatinib+pembrolizumabExperimental Treatment2 Interventions
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week (Q6W) Cycle for up to 18 cycles (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily until progressive disease.
Group II: standard of care treatment (regorafenib OR TAS-102)Active Control2 Interventions
Participants receive regorafenib 160 mg via oral tablet once daily on Days 1 through 21 of each 4-week cycle OR TAS-102 (trifluridine and tipiracil hydrochloride) 35 mg/m^2 via oral tablet twice a day on Days 1 through 5 and Days 8-12 of each 4-week cycle until progressive disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
lenvatinib
2018
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,540 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,342 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,091 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of the ingredients in it.I had radiotherapy less than 2 weeks before starting the study treatment.I had a blood clot in an artery in the last year.I have a severe fistula.I have fluid buildup needing drainage or medication in the last 2 weeks.My tumor is identified as MSI-H/dMMR.I am currently being treated for an infection.I have had pneumonitis treated with steroids or have it now.My heart's pumping ability is below normal.I've been treated with specific immune and blood vessel growth inhibitors.I have been diagnosed with HIV.My scans show cancer affecting major blood vessels in my chest.I have a history of Hepatitis B or active Hepatitis C.I am fully active or restricted in physically strenuous activity but can do light work.I have not had a live vaccine in the last 30 days.My cancer can be measured and I can provide a tissue sample that hasn't been treated with radiation.I have received an organ or tissue transplant from another person.I have provided a sample of my tumor that hasn't been treated with radiation to a lab.I haven't had serious heart problems in the last year.I do not have severe heart failure.I have not had any cancer treatment or experimental drugs in the last 28 days.My colorectal cancer is advanced and cannot be surgically removed, and it is not MSI-H/dMMR.I can take medicine in pill form or through a feeding tube.You are currently taking part in another research study or have recently participated in one involving experimental drugs or devices within the past 28 days.My cancer progressed after standard treatments, including specific drugs if they were available and suitable for my cancer type.I have taken regorafenib or TAS-102 before.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 3 years.I am not pregnant or breastfeeding, and if I can have children, I use effective birth control and won't donate eggs.I have a gut condition that could affect how I absorb medication.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have not had major surgery in the last 3 weeks.My cancer has spread to my brain or spinal cord.I have not taken any immune system boosters in the last 4 weeks.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have been treated for an autoimmune disease in the last 2 years.My blood pressure is ≤150/90 mmHg and stable on current medications.You have experienced bad reactions or side effects from lenvatinib, regorafenib, or TAS-102, or any of the substances used to make them.I have a serious wound, ulcer, or bone fracture that is not healing.I am receiving treatment that may or may not include a drug targeting blood vessel growth.I agree to not donate sperm and either abstain from sex or use contraception during and after treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the precedence of lenvatinib in research?
"Lenvatinib is currently being trialled in 1169 active clinical trials, 142 of which are in Phase 3. Many of the ongoing trials for lenvatinib are situated in Houston, Texas; however, there are 38289 total clinical trial locations for lenvatinib."
Answered by AI
What are the latest updates on lenvatinib's FDA approval?
"There is some efficacy data and multiple rounds of safety data available from Phase 3 trials, making lenvatinib a safe medication according to our team's estimation."
Answered by AI
Are there any open positions for volunteers in this clinical research project?
"The clinical trial in question appears to have completed recruitment, based on the information available on clinicaltrials.gov. The study was originally posted on 29 March 2021 and last edited on 21 July 2022. Although this particular trial is no longer recruiting, there are 2060 other studies that are currently doing so."
Answered by AI
How many individuals are allowed to enroll in this clinical trial?
"This particular study has completed recruitment for patients. It was originally posted on March 29th, 2021 and was last updated on July 21st, 2022. 891 other trials are currently looking for enrolment from patients with colorectal cancer and 1169 trials for lenvatinib are actively recruiting participants."
Answered by AI
Who else is applying?
What site did they apply to?
China Medical University Hospital-Surgical Department ( Site 1903)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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