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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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I can take pills and don't have major gut issues affecting medicine absorption.
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I have had specific immune therapy and my cancer did not respond well.
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I have received at least 2 doses of a PD-1/PD-L1 inhibitor.
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My cancer has worsened after treatment with a specific immunotherapy.
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I have a tumor or lymph node that can be measured and meets size requirements.
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I am fully active or can carry out light work.
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My tumor can be biopsied, and I agree to have this done before starting the treatment plan.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0203411058%
Pyrexia
42%
Nausea
35%
Vomiting
33%
Diarrhoea
33%
Fatigue
28%
Gamma-glutamyltransferase increased
28%
Chills
28%
Rash
26%
Aspartate aminotransferase increased
23%
White blood cell count decreased
23%
Cough
23%
Anaemia
23%
Decreased appetite
23%
Headache
21%
Constipation
21%
Blood alkaline phosphatase increased
19%
Dry mouth
19%
Hyperglycaemia
19%
Myalgia
16%
Alanine aminotransferase increased
16%
Asthenia
16%
Abdominal pain upper
16%
Thrombocytopenia
16%
Dyspnoea
14%
Hypertension
14%
Arthralgia
14%
Insomnia
12%
Platelet count decreased
12%
Eczema
12%
Blood creatinine increased
12%
Pruritus
12%
Abdominal pain
12%
Hypomagnesaemia
12%
Hyponatraemia
12%
Erythema
9%
Rash maculo-papular
9%
Oedema peripheral
9%
Hypokalaemia
9%
Dermatitis acneiform
9%
Neutrophil count decreased
9%
Weight increased
9%
Back pain
9%
Dry skin
7%
Blood bilirubin increased
7%
Sepsis
7%
Neutropenia
7%
Mucosal inflammation
7%
Oedema
7%
Cholangitis
7%
Hypoalbuminaemia
7%
Stomatitis
7%
Dyspepsia
7%
Influenza like illness
7%
Herpes zoster
7%
Glycosylated haemoglobin increased
7%
Weight decreased
7%
Musculoskeletal pain
7%
Pain in extremity
7%
Anxiety
7%
Acute kidney injury
7%
Night sweats
5%
Hypophosphataemia
5%
Skin lesion
5%
Erythema nodosum
5%
Dry eye
5%
Toothache
5%
Muscle spasms
5%
Blood creatine phosphokinase increased
5%
Hyperuricaemia
5%
Gastrooesophageal reflux disease
5%
Leukopenia
5%
Folliculitis
5%
Urinary tract infection
5%
Fall
5%
Lymphocyte count decreased
5%
Hypoglycaemia
5%
Joint swelling
5%
Neuropathy peripheral
5%
Epistaxis
5%
Oropharyngeal pain
5%
Acne
5%
Hyperkeratosis
2%
Femoral neck fracture
2%
Productive cough
2%
Hot flush
2%
Hypersensitivity
2%
Upper respiratory tract infection
2%
Pain in jaw
2%
Epilepsy
2%
Peripheral sensory neuropathy
2%
Depression
2%
Hypercalcaemia
2%
Dizziness
2%
Skin mass
2%
Pneumonia
2%
Thrombophlebitis
2%
Tachycardia
2%
Musculoskeletal chest pain
2%
Dysgeusia
2%
Sciatica
2%
Gastroenteritis
2%
Febrile neutropenia
2%
Atrial fibrillation
2%
Oral pain
2%
Rectal haemorrhage
2%
Paronychia
2%
Device related infection
2%
Rhinitis
2%
Sinusitis
2%
Respiratory tract infection
2%
Hyperkalaemia
2%
Transaminases increased
2%
Dehydration
2%
Spinal pain
2%
Haemorrhoids
2%
Cataract
2%
Eye pain
2%
Vision blurred
2%
Visual impairment
2%
Abdominal discomfort
2%
Abdominal distension
2%
Gait disturbance
2%
Non-cardiac chest pain
2%
Xerosis
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Rash pustular
2%
Tooth abscess
2%
Tooth infection
2%
Procedural pain
2%
Blood lactate dehydrogenase increased
2%
Blood uric acid increased
2%
C-reactive protein increased
2%
Muscular weakness
2%
Neck pain
2%
Basal cell carcinoma
2%
Seborrhoeic keratosis
2%
Paraesthesia
2%
Proteinuria
2%
Renal failure
2%
Nasal congestion
2%
Pleural effusion
2%
Nail discolouration
2%
Palmar-plantar erythrodysaesthesia syndrome
2%
Photosensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biliary Tract Cancer (BTC) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Multiple Myeloma (MM) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (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)
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 2
~2010
Trametinib
2014
Completed Phase 2
~1550
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,471 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,334 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor have any open spots for participants?
"This research is no longer actively recruiting participants; it was initially posted on February 3rd 2018 and had its most recent update on July 5th 2022. For those still looking for a trial, there are 4155 clinical studies currently accepting patients with lung cancer and 1042 investigating the use of Trametinib."
Answered by AI
What are the common applications of Trametinib?
"Trametinib is generally prescribed to treat cancerous growths. It can also provide relief for those with advanced melanoma, microsatellite instability high tumours, and post-chemotherapy progression of diseases."
Answered by AI
How many volunteers are contributing to this medical experiment?
"This medical trial has closed its recruitment process. The period of enrollment for this clinical experiment was between February 3rd 2018 and July 5th 2022. If you are looking to get involved in a similar study, there are currently 4155 trials related to lung cancer requiring participants and 1042 trials handling Trametinib that accept volunteers."
Answered by AI
Are there any other trials that have investigated the effects of Trametinib?
"Currently, a substantial number of Trametinib trials are in operation - 1,042 to be exact. Of those studies, 128 have reached Phase 3 and each require 41384 locations to run the trial properly. Rochester Minnesota serves as one of the primary research hubs for this medication's clinical assessment."
Answered by AI
Who else is applying?
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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