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Checkpoint Inhibitor
Trametinib + Pembrolizumab for Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Ferdinandos Skoulidis, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 1.5 x upper limit of normal (ULN) or >= 60 mL/minute for subjects with creatinine levels > 1.5 x the institutional ULN
Patients must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Must not have
Has 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
Has had prior monoclonal antibody therapy within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events (AEs) due to agents administered more than 4 weeks earlier
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of trametinib when given with pembrolizumab to treat patients with non-small cell lung cancer that has returned or spread.
Who is the study for?
This trial is for adults with non-small cell lung cancer that has spread, can't be surgically removed, or has returned after treatment. Participants must have had disease progression within 12 weeks of prior immunotherapy, be in good physical condition (ECOG 0-1), and have adequate organ function. They should not be pregnant or breastfeeding and must agree to use contraception. People who've received certain treatments recently or have specific health conditions like active hepatitis B/C, brain metastases, or uncontrolled heart issues cannot join.
What is being tested?
The trial is testing the combination of two drugs: Trametinib and Pembrolizumab. Trametinib blocks enzymes needed for tumor growth while Pembrolizumab boosts the immune system's ability to fight cancer. The study aims to determine the best dose and effectiveness of this drug combo in treating advanced stages of non-small cell lung cancer.
What are the potential side effects?
Possible side effects include skin rash, fatigue, diarrhea, liver enzyme changes suggesting inflammation or damage, high blood pressure due to trametinib; pembrolizumab may cause immune-related reactions affecting organs like lungs (pneumonitis) or intestines (colitis), infusion reactions as well as general symptoms such as tiredness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine, is within the normal range.
Select...
I can take pills and don't have major gut issues affecting medicine absorption.
Select...
I have had specific immune therapy and my cancer did not respond well.
Select...
I have received at least 2 doses of a PD-1/PD-L1 inhibitor.
Select...
My cancer has worsened after treatment with a specific immunotherapy.
Select...
I have a tumor or lymph node that can be measured and meets size requirements.
Select...
I am fully active or can carry out light work.
Select...
My tumor can be biopsied, and I agree to have this done before starting the treatment plan.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Select...
I haven't had monoclonal antibody therapy in the last 4 weeks or have recovered from its side effects.
Select...
I stopped an immune therapy due to a severe side effect.
Select...
I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
Select...
I have lung issues that needed steroids for treatment.
Select...
I am currently being treated for an infection.
Select...
I have active hepatitis B or C.
Select...
I have or am at risk for blocked blood vessels in my eye.
Select...
I am not on medication that affects heart rhythm or can switch before treatment starts.
Select...
I have been diagnosed with HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall objective response rate evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1 and immune related [ir]RECIST)
Side effects data
From 2021 Phase 2 trial • 206 Patients • NCT0203411047%
Pyrexia
36%
Fatigue
33%
Anaemia
33%
Nausea
33%
Decreased appetite
28%
Rash
22%
Headache
22%
Constipation
22%
Pneumonia
22%
Chills
22%
Dyspnoea
19%
Dizziness
19%
Hypoalbuminaemia
19%
Vomiting
19%
Diarrhoea
19%
Hyponatraemia
17%
Dysphagia
17%
Blood alkaline phosphatase increased
17%
Back pain
14%
Aspartate aminotransferase increased
14%
Hypocalcaemia
14%
Dry mouth
14%
Hyperglycaemia
14%
Arthralgia
14%
Oedema peripheral
14%
White blood cell count decreased
14%
Insomnia
14%
Hypotension
11%
Hypokalaemia
11%
Haemoptysis
11%
Alanine aminotransferase increased
11%
Dry skin
11%
Hypothyroidism
11%
Pruritus
11%
Visual impairment
11%
Weight decreased
11%
Cough
8%
Productive cough
8%
Upper respiratory tract infection
8%
Rash maculo-papular
8%
Mucosal inflammation
8%
Hypercalcaemia
8%
Gastrooesophageal reflux disease
8%
Pleural effusion
8%
Night sweats
8%
Asthenia
8%
Ejection fraction decreased
8%
Electrocardiogram QT prolonged
8%
Gamma-glutamyltransferase increased
8%
Neutrophil count decreased
8%
Neck pain
6%
Rhinorrhoea
6%
Seborrhoeic keratosis
6%
Haematochezia
6%
Skin lesion
6%
Acute kidney injury
6%
Pulmonary embolism
6%
Thrombocytopenia
6%
Atrial fibrillation
6%
Stomatitis
6%
Rhinitis allergic
6%
Tachycardia
6%
Abdominal pain upper
6%
Hyperuricaemia
6%
Leukopenia
6%
Sinusitis
6%
Urinary tract infection
6%
Polyneuropathy
6%
Haematuria
6%
Neutropenia
6%
Ear pain
6%
Abdominal pain
6%
Feeling cold
6%
Non-cardiac chest pain
6%
Pain
6%
Fungal infection
6%
Nasopharyngitis
6%
Blood creatinine increased
6%
Blood urea increased
6%
Neutrophil count increased
6%
Hypomagnesaemia
6%
Myalgia
6%
Neuropathy peripheral
6%
Proteinuria
6%
Nasal congestion
6%
Pneumonitis
6%
Palmar-plantar erythrodysaesthesia syndrome
3%
Pelvic infection
3%
Rhabdomyolysis
3%
Tinnitus
3%
Sepsis
3%
Malaise
3%
Cataract
3%
Dermatitis acneiform
3%
Erythema nodosum
3%
Femoral neck fracture
3%
Hyperglycaemic hyperosmolar nonketotic syndrome
3%
Aortic thrombosis
3%
Pollakiuria
3%
Hypophosphataemia
3%
Flushing
3%
Oesophageal stenosis
3%
Atrioventricular block first degree
3%
Photophobia
3%
Dehydration
3%
Toothache
3%
Oral candidiasis
3%
Urinary retention
3%
Alopecia
3%
Skin mass
3%
Aspiration
3%
Vision blurred
3%
Oedema
3%
Depression
3%
Folliculitis
3%
Staphylococcal infection
3%
Clavicle fracture
3%
Aphasia
3%
Cardiac ventricular thrombosis
3%
Stress cardiomyopathy
3%
Oral pain
3%
Clostridium difficile infection
3%
Diverticulitis
3%
Pneumonia aspiration
3%
Pneumonia necrotising
3%
Wound infection
3%
Hyperkalaemia
3%
Rib fracture
3%
Bladder transitional cell carcinoma
3%
Facial nerve disorder
3%
Hypertension
3%
Paralysis recurrent laryngeal nerve
3%
Syncope
3%
Hallucination
3%
Pulmonary haematoma
3%
Sinus bradycardia
3%
Dry eye
3%
Abdominal distension
3%
Dyspepsia
3%
Gait disturbance
3%
Nodule
3%
Xerosis
3%
Conjunctivitis
3%
Tooth infection
3%
Procedural pain
3%
Blood creatine phosphokinase increased
3%
Platelet count decreased
3%
Weight increased
3%
Flank pain
3%
Muscular weakness
3%
Musculoskeletal chest pain
3%
Pain in extremity
3%
Hypoaesthesia
3%
Paraesthesia
3%
Anxiety
3%
Sleep disorder
3%
Dysphonia
3%
Epistaxis
3%
Upper-airway cough syndrome
3%
Wheezing
3%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Biliary Tract Cancer (BTC) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Multiple Myeloma (MM) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib, pembrolizumab)Experimental Treatment3 Interventions
Patients receive trametinib PO QD 14 days prior to cycle 1 and days 1-10 of each course (10 days on, 11 days off). Beginning in cycle 2, participants also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
Trametinib
2014
Completed Phase 2
~1630
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,554 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,543 Total Patients Enrolled
Ferdinandos Skoulidis, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had specific immune therapy and my cancer did not respond well.I haven't had monoclonal antibody therapy in the last 4 weeks or have recovered from its side effects.My kidney function, measured by creatinine, is within the normal range.My NSCLC is advanced, cannot be surgically removed, and has been treated before.Your platelet count should be at least 100,000 per cubic millimeter.I can take pills and don't have major gut issues affecting medicine absorption.I have received at least 2 doses of a PD-1/PD-L1 inhibitor.My cancer has worsened after treatment with a specific immunotherapy.My cancer has worsened within 12 weeks after my last anti PD-1/PD-L1 treatment.I haven't used any experimental drugs or treatments in the last 4 weeks.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am currently being treated for an infection.I have active hepatitis B or C.I have or am at risk for blocked blood vessels in my eye.I am not on medication that affects heart rhythm or can switch before treatment starts.I have a tumor or lymph node that can be measured and meets size requirements.My blood clotting time is normal or managed with medication.I am not pregnant and agree to use birth control during and up to 120 days after the study.I have previously been treated with a MEK inhibitor.I stopped an immune therapy due to a severe side effect.I haven't had chemotherapy or radiation recently, or I've recovered from their side effects.I have another cancer besides the one being studied, but it's either not growing or doesn't need treatment right now, except for certain skin cancers or treated cervical cancer.I have stable brain metastases and haven't used steroids in the last 7 days.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have lung issues that needed steroids for treatment.I have fluid buildup in my abdomen or chest but am stable after treatment.I do not have significant heart problems or a history of serious heart conditions.I have been tested for EGFR and ALK before joining, and if positive, I've had specific treatments but my cancer progressed.I am fully active or can carry out light work.My hemoglobin level is at least 9 g/dL without recent treatments to increase it.My blood clotting time is normal or managed if I'm on blood thinners.My tumor can be biopsied, and I agree to have this done before starting the treatment plan.I have not received a live vaccine in the last 30 days.I have been diagnosed with HIV.My liver enzymes are within the required range for my condition.Your absolute neutrophil count is at least 1.5 x 10^9/L or 1500/mm^3.Your bilirubin levels in the blood should not be too high.I stopped my standard cancer treatment because of severe side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (trametinib, pembrolizumab)
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.