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Tyrosine Kinase Inhibitor
Lenvatinib + Pembrolizumab for Salivary Gland Cancer
Phase 2
Recruiting
Led By Alan Ho, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be able to swallow and retain oral medication or have a functioning G-tube in place.
Patients must have RECIST V1.1 measurable disease defined as at least one non-nodal lesion measuring ≥ 20 mm with conventional techniques or as ≥10mm with CT scan, MRI, or calipers by clinical exam in the longest dimension AND/OR a nodal lesion measuring > 15 mm in the shortest dimension. Tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the effectiveness of two drugs, lenvatinib and pembrolizumab, in treating advanced Adenoid Cystic Carcinoma or other salivary gland cancers that have come back or spread to other parts of the body.
Who is the study for?
Adults with advanced Adenoid Cystic Carcinoma or other salivary gland cancers that have returned or spread, who've had no recent treatments causing unresolved side effects. They must be able to swallow pills (or have a G-tube), not be pregnant or breastfeeding, and agree to use contraception. Participants need measurable disease and available tumor tissue for study.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of lenvatinib combined with pembrolizumab in treating advanced salivary gland cancers. It aims to determine if these drugs can help control the cancer when it has recurred or spread elsewhere in the body.See study design
What are the potential side effects?
Potential side effects include high blood pressure, proteinuria (excess protein in urine), heart issues like congestive heart failure or arrhythmias, bleeding events, infections due to immune system suppression, allergic reactions to drug components, pneumonitis/interstitial lung disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills or have a working G-tube.
Select...
My cancer can be measured by scans and has grown despite previous treatments.
Select...
I am fully active or able to carry out light work.
Select...
My cancer has returned or spread and cannot be cured with surgery or other treatments.
Select...
I have been diagnosed with adenoid cystic carcinoma.
Select...
I am a male and agree to use contraception and not father children during and up to 120 days after the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
best overall response rate
Secondary outcome measures
median progression-free survival (PFS)
Side effects data
From 2019 Phase 3 trial • 392 Patients • NCT0132155465%
Diarrhoea
61%
Hypertension
52%
Weight decreased
51%
Decreased appetite
42%
Vomiting
41%
Fatigue
40%
Nausea
39%
Dysphonia
33%
Stomatitis
31%
Proteinuria
29%
Constipation
28%
Palmar-plantar erythrodysaesthesia syndrome
27%
Cough
25%
Asthenia
24%
Abdominal pain
22%
Headache
22%
Arthralgia
21%
Oedema peripheral
21%
Back pain
19%
Dyspnoea
18%
Dysphagia
18%
Dizziness
16%
Epistaxis
16%
Rash
16%
Musculoskeletal pain
14%
Hypoalbuminaemia
14%
Myalgia
14%
Pain in extremity
13%
Insomnia
13%
Dyspepsia
13%
Hypocalcaemia
13%
Dry mouth
13%
Muscle spasms
13%
Musculoskeletal chest pain
13%
Abdominal pain upper
12%
Dry skin
12%
Dysgeusia
12%
Pyrexia
11%
Electrocardiogram QT prolonged
11%
Alopecia
11%
Glossodynia
11%
Oropharyngeal pain
11%
Haemoptysis
9%
Hypotension
9%
Alanine aminotransferase increased
8%
Anaemia
8%
Ejection fraction decreased
8%
Thrombocytopenia
8%
Hypothyroidism
8%
Toothache
7%
Pneumonia
7%
General physical health deterioration
7%
Blood creatinine increased
7%
Hypomagnesaemia
7%
Aspartate aminotransferase increased
7%
Urinary tract infection
7%
Neck pain
7%
Haemorrhoids
7%
Haematuria
7%
Nasopharyngitis
7%
Sinusitis
6%
Hyperglycaemia
6%
Bronchitis
6%
Depression
6%
Muscular weakness
6%
Hyponatraemia
6%
Blood thyroid stimulating hormone increased
6%
Oral pain
6%
Cheilitis
6%
Anxiety
6%
Malaise
6%
Blood alkaline phosphatase increased
6%
Upper respiratory tract infection
6%
Decubitus ulcer
5%
Dermatitis acneiform
5%
Lipase increased
4%
Death
4%
Non-cardiac chest pain
4%
Flank pain
4%
Atrial fibrillation
4%
Cerebrovascular accident
4%
Malignant neoplasm progression
4%
Metastatic pain
4%
Flatulence
4%
Productive cough
2%
Joint swelling
2%
Paraesthesia
2%
Pathological fracture
2%
Respiratory failure
2%
Hyperhidrosis
2%
Hypertensive crisis
2%
Gastrooesophageal reflux disease
2%
Dehydration
2%
Diverticular perforation
2%
Respiratory distress
2%
Platelet count decreased
2%
Gingival pain
1%
Aneurysm ruptured
1%
Febrile neutropenia
1%
Appendicitis perforated
1%
Abscess intestinal
1%
Hypercalcaemia
1%
Eschar
1%
Anal abscess
1%
Blood uric acid increased
1%
Osteomyelitis
1%
Pneumothorax
1%
Spinal cord ischaemia
1%
Cholecystitis
1%
Intracranial tumour haemorrhage
1%
Intestinal perforation
1%
Pleuritic pain
1%
Sepsis
1%
Acute respiratory distress syndrome
1%
Implant site infection
1%
Mesenteric artery thrombosis
1%
Pneumonia staphylococcal
1%
Splenic rupture
1%
Pneumonia necrotising
1%
Respiratory depression
1%
Pain
1%
Osmotic demyelination syndrome
1%
Pancreatitis
1%
Facial paresis
1%
Diabetic encephalopathy
1%
Cardiac failure
1%
Dyspnoea exertional
1%
Fungal skin infection
1%
Syncope
1%
Retinal detachment
1%
Dental cyst
1%
Blood cholesterol increased
1%
Acute myocardial infarction
1%
Confusional state
1%
Postmenopausal haemorrhage
1%
Gastroenteritis viral
1%
Hyperaesthesia
1%
Sciatica
1%
Empyema
1%
Urinary incontinence
1%
Pulmonary haemorrhage
1%
Subarachnoid haemorrhage
1%
Anal fistula
1%
Angioedema
1%
Atrial flutter
1%
Cardiac arrest
1%
Cauda equina syndrome
1%
Cellulitis
1%
Chest pain
1%
Cholelithiasis
1%
Chronic obstructive pulmonary disease
1%
Colonic abscess
1%
Coma
1%
Device breakage
1%
Diverticulitis
1%
Appendicitis
1%
Tachycardia
1%
Gastroenteritis
1%
Hypovolaemia
1%
Inguinal hernia
1%
Laryngeal necrosis
1%
Laryngeal obstruction
1%
Laryngeal oedema
1%
Lung disorder
1%
Lung infection
1%
Malignant pleural effusion
1%
Metastases to bone
1%
Hypokalaemia
1%
Cancer pain
1%
Palpitations
1%
Hepatocellular injury
1%
Mobility decreased
1%
Metastatic pulmonary embolism
1%
Dermatitis contact
1%
Thrombophlebitis
1%
Skin fissures
1%
Pyelonephritis
1%
Ventricular tachycardia
1%
Soft tissue necrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OOL, Treatment Period: Lenvatinib 24 mg
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 20 mg
Trial Design
2Treatment groups
Experimental Treatment
Group I: recurrent/metastatic non-ACC salivary gland cancers (R/M SGC).Experimental Treatment2 Interventions
All eligible patients will undergo informed consent and screening for trial enrollment.
Enrolled patients will receive a starting lenvatinib dose of 20mg daily taken orally and pembrolizumab 200mg intravenously every 3 weeks (1 cycle=3 weeks)
Group II: recurrent/metastatic adenoid cystic carcinoma (R/M ACC)Experimental Treatment2 Interventions
All eligible patients will undergo informed consent and screening for trial enrollment.
Enrolled patients will receive a starting lenvatinib dose of 20mg daily taken orally and pembrolizumab 200mg intravenously every 3 weeks (1 cycle=3 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,791 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,918 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,019 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have not received a live vaccine within the last 30 days.I have or had lung inflammation that needed steroids.I do not have any infections requiring treatment through my bloodstream.I haven't had any blood clot issues like a stroke or deep vein thrombosis in the last 6 months.I haven't taken any immune system boosters in the last 4 weeks, but I am on a stable dose of erythropoietin.I am 18 years old or older.My brain metastases are stable and I haven't needed steroids for 14 days.I can swallow pills or have a working G-tube.I am positive for HIV, Hepatitis C, or Hepatitis B.I had cancer other than skin cancer more than 2 years ago and am now cancer-free.My cancer can be measured by scans and has grown despite previous treatments.It's been over 4 weeks since my last cancer treatment and any side effects are mild or gone.I am not pregnant, breastfeeding, or planning to become pregnant soon, and I cannot have children due to surgery or menopause.I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for thyroid issues, vitiligo, type 1 diabetes, or psoriasis.I have not had serious heart issues like heart failure, unstable angina, heart attack, or dangerous arrhythmias in the last 6 months.I have had an organ or tissue transplant.I have a serious wound, ulcer, or fracture that is not healing and is not caused by cancer.I haven't taken any cancer treatment or experimental drugs in the last 4 weeks.I have not had severe bleeding in the last 4 weeks.I don't have conditions affecting drug absorption in my gut.My urine protein levels are not high.My cancer has worsened or shown new symptoms in the last 6 months.I have not used lenvatinib or any PD-1/PD-L1, anti-PD-L2, CTLA-4, OX-40, or CD137 therapies.I am not on any cancer treatments except for bone treatments or palliative radiation if started before joining the study.I have salivary gland cancer, but it's not adenoid cystic carcinoma.I am on dialysis for kidney failure.My high blood pressure is not controlled, even with medication.I am fully active or able to carry out light work.My cancer has returned or spread and cannot be cured with surgery or other treatments.I have been diagnosed with adenoid cystic carcinoma.I am a male and agree to use contraception and not father children during and up to 120 days after the trial.
Research Study Groups:
This trial has the following groups:- Group 1: recurrent/metastatic non-ACC salivary gland cancers (R/M SGC).
- Group 2: recurrent/metastatic adenoid cystic carcinoma (R/M ACC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active 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.
Are there multiple venues in the US that are engaged with this research?
"Presently, this medical trial is being conducted in 8 separate locations around the country including Miami, Commack and Montvale. To minimize travel requirements for participants, it's highly recommended to select the nearest site if possible."
Answered by AI
To what magnitude is the current enrollment for this experiment?
"This medical trial requires 64 volunteers that are eligible for inclusion. Participants may be recruited from various locations, including Baptist Alliance MCI in Miami and Memorial Sloan Kettering Commack (All Protocol Activities) located in New jersey."
Answered by AI
Is registration open for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this ongoing medical study was first posted on June 2nd 2020 and most recently updated October 26th 2022. The recruitment process is actively seeking 64 patients at 8 different sites."
Answered by AI
Are there any adverse effects associated with Lenvatinib treatments?
"Lenvatinib is deemed to be moderately safe as it has been subjected to a Phase 2 clinical trial, providing some evidence of safety but no data in terms of efficacy. As such, the risk factor was assessed at a score of two."
Answered by AI
In what therapeutic circumstances is Lenvatinib typically prescribed?
"Lenvatinib is commonly prescribed to combat malignant neoplasms, however it can also be useful in treating unresectable melanoma, microsatellite instability high and cases of chemotherapy-induced disease progression."
Answered by AI
Could you provide an overview of the research projects that have explored Lenvatinib as a therapeutic option?
"Currently, 1032 clinical trials are actively studying Lenvatinib's efficacy. 134 of these research projects have moved into Phase 3 testing. Most tests for this medication are located in Sacramento, California; however there is a total of 37 061 sites running investigations on Lenvatinib worldwide."
Answered by AI
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