← Back to Search

Monoclonal Antibodies

Bintrafusp Alfa + Pimasertib for Brain Cancer

Phase 1 & 2
Waitlist Available
Led By Hussein A Tawbi
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a combination of two immunotherapy drugs to see if they are effective in treating brain cancer.

Who is the study for?
This trial is for adults with brain metastases from cancers like breast cancer, melanoma, or lung cancer. Participants must have had prior treatments and be in stable condition without needing steroids recently. They should have a life expectancy over 12 weeks, acceptable organ function, and at least one measurable brain lesion. Women must not be pregnant or breastfeeding and agree to birth control measures.Check my eligibility
What is being tested?
The trial tests Bintrafusp Alfa (an immunotherapy drug) combined with Pimasertib (a drug that blocks enzymes needed for cell growth) on patients with brain metastases from various cancers. It aims to find the best dose and see if this combination can prevent worsening of the disease.See study design
What are the potential side effects?
Potential side effects may include immune system reactions leading to inflammation in different organs, infusion-related reactions similar to allergic responses, fatigue, issues affecting blood cells which could increase infection risk, as well as possible liver enzyme changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical benefit rate
Incidence of intracranial and extracranial toxicities and dose-limiting toxicities (Phase I)
Overall survival (Phase II)
+2 more
Secondary outcome measures
Best achieved extracranial objective response rate
Dose, duration and frequency of steroid use for symptomatic management
Duration of response
+2 more

Side effects data

From 2016 Phase 2 trial • 194 Patients • NCT01693068
82%
Diarrhoea
66%
Blood creatine phosphokinase increased
45%
Oedema peripheral
43%
Retinal detachment
36%
Nausea
36%
Dermatitis acneiform
35%
Rash
30%
Fatigue
30%
Asthenia
24%
Abdominal pain
23%
Vomiting
22%
Vision blurred
21%
Pyrexia
20%
Dyspnoea
18%
Constipation
17%
Decreased appetite
16%
Hypertension
16%
Stomatitis
15%
Dry mouth
14%
Eyelid oedema
14%
Myalgia
13%
Dizziness
13%
Aspartate aminotransferase increased
13%
Pruritus
13%
Skin fissures
13%
Folliculitis
12%
Rash pustular
12%
Headache
11%
Erythema
10%
Hypokalaemia
10%
Alopecia
10%
Anaemia
10%
Ejection fraction decreased
9%
Rash maculo-papular
9%
Visual impairment
9%
Periorbital oedema
9%
Face oedema
8%
Dysgeusia
8%
Macular detachment
8%
Dyspepsia
8%
Chills
8%
Hypoalbuminaemia
8%
Dry skin
8%
Lymphoedema
7%
Lymphopenia
7%
Cough
7%
Weight increased
7%
Arthralgia
7%
Pain in extremity
7%
Paronychia
6%
Dysuria
6%
Weight decreased
6%
Thrombocytopenia
6%
Rectal haemorrhage
6%
Back pain
6%
Muscular weakness
6%
Eczema
6%
Conjunctivitis
6%
Nasopharyngitis
6%
Epistaxis
5%
Mouth ulceration
5%
Hepatocellular injury
5%
Erysipelas
5%
Alanine aminotransferase increased
5%
Hyponatraemia
5%
Urinary tract infection
5%
Platelet count decreased
5%
Somnolence
5%
Insomnia
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Macular oedema
4%
Neck pain
4%
Dysphagia
4%
Dry eye
4%
Visual acuity reduced
4%
Sciatica
4%
Gastrooesophageal reflux disease
4%
Blood alkaline phosphatase increased
4%
Tricuspid valve incompetence
4%
Malaise
4%
Peripheral swelling
4%
Oral candidiasis
4%
Lymphocyte count decreased
4%
Hyperkalaemia
4%
Memory impairment
4%
Dysphonia
4%
Rash generalised
3%
Acute kidney injury
3%
Odynophagia
3%
Retinal vein occlusion
3%
Cheilitis
3%
Skin infection
3%
Rash papular
3%
Dyspnoea exertional
3%
Aphthous stomatitis
3%
Abdominal distension
3%
Paraesthesia
3%
Cholestasis
3%
Pain of skin
3%
Gamma-glutamyltransferase increased
3%
Hypomagnesaemia
3%
Acne
3%
Left ventricular dysfunction
3%
Mitral valve incompetence
3%
Haemorrhoids
3%
Electrocardiogram QT prolonged
3%
Dehydration
3%
Syncope
3%
Proteinuria
3%
Oropharyngeal pain
3%
Pleural effusion
3%
Intertrigo
3%
Rash erythematous
3%
Skin exfoliation
3%
Swelling face
3%
Hypotension
3%
Macular fibrosis
2%
Ocular hypertension
2%
Feeling cold
2%
Oedema
2%
Scab
2%
Groin pain
2%
Basal cell carcinoma
2%
Presyncope
2%
Haematuria
2%
Loss of consciousness
2%
Skin candida
2%
Musculoskeletal pain
2%
Pulmonary embolism
2%
General physical health deterioration
2%
Impetigo
2%
Ascites
2%
Flatulence
2%
Fall
2%
White blood cell count decreased
2%
Hypocalcaemia
2%
Lacrimation increased
2%
Bradycardia
2%
Sepsis
2%
Angina pectoris
2%
Leukocytosis
2%
Atrial fibrillation
2%
Chromatopsia
2%
Photophobia
2%
Photopsia
2%
Tinea cruris
2%
Herpes zoster
2%
Eye disorder
2%
Haemoglobin decreased
2%
Trismus
2%
Faeces discoloured
2%
Dysarthria
2%
Amnesia
2%
Pharyngitis
2%
Photosensitivity reaction
2%
Skin burning sensation
2%
Urticaria
2%
Ear pain
2%
Hypochromic anaemia
2%
Chorioretinopathy
2%
Confusional state
2%
Stasis dermatitis
2%
Cardiac failure
2%
Macular degeneration
2%
Retinal pigment epitheliopathy
2%
Wound
2%
C-reactive protein increased
2%
Oliguria
2%
Disease progression
2%
Sudden death
2%
Cellulitis
2%
Lymphadenopathy
2%
Normochromic normocytic anaemia
2%
Aortic valve incompetence
2%
Atrioventricular block
2%
Bundle branch block right
2%
Sinus tachycardia
2%
Tinnitus
2%
Vertigo
2%
Conjunctival oedema
2%
Detachment of retinal pigment epithelium
2%
Eye pain
2%
Eye swelling
2%
Eyelid ptosis
2%
Abdominal pain upper
2%
Gastritis
2%
Glossitis
2%
Glossodynia
2%
Haemorrhoidal haemorrhage
2%
Tongue disorder
2%
Tongue ulceration
2%
Toothache
2%
Chest pain
2%
Influenza like illness
2%
Acute tonsillitis
2%
Cystitis
2%
Herpes simplex
2%
Influenza
2%
Localised infection
2%
Oral herpes
2%
Lethargy
2%
Vaginal infection
2%
Blood albumin decreased
2%
Blood creatinine increased
2%
Blood lactate dehydrogenase increased
2%
Intraocular pressure increased
2%
Lipase increased
2%
Neutrophil count decreased
2%
Diabetes mellitus
2%
Fluid retention
2%
Hyperglycaemia
2%
Hypophosphataemia
2%
Joint swelling
2%
Spinal osteoarthritis
2%
Peripheral sensory neuropathy
2%
Sensory disturbance
2%
Tremor
2%
Visual field defect
2%
Anxiety
2%
Urinary retention
2%
Papule
2%
Hypoxia
2%
Nasal disorder
2%
Pneumonitis
2%
Respiratory failure
2%
Wheezing
2%
Dermatitis
2%
Dermatitis exfoliative
2%
Hyperhidrosis
2%
Ingrowing nail
2%
Rash macular
2%
Rosacea
1%
Rhinitis
1%
Monoclonal gammopathy
1%
Eye inflammation
1%
Gout
1%
Ageusia
1%
Renal injury
1%
Generalised oedema
1%
Left ventricular hypertrophy
1%
Paraesthesia oral
1%
Staphylococcal skin infection
1%
Depressed level of consciousness
1%
Solar dermatitis
1%
Oral pain
1%
Pseudomonas infection
1%
Oral mucosal erythema
1%
Troponin increased
1%
Electrocardiogram repolarisation abnormality
1%
Dysaesthesia
1%
Aortic valve disease
1%
Oral dysaesthesia
1%
Respiratory tract infection
1%
Ataxia
1%
Drug intolerance
1%
White blood cell count increased
1%
Muscle contracture
1%
Glomerular filtration rate decreased
1%
Excoriation
1%
Eye haemorrhage
1%
Superinfection viral
1%
Impaired healing
1%
Oral toxicity
1%
Gastric ulcer
1%
Chondrocalcinosis
1%
Blood potassium increased
1%
Leukopenia
1%
Oral mucosal eruption
1%
Eye discharge
1%
Oral discomfort
1%
Hypoproteinaemia
1%
Cervicobrachial syndrome
1%
Skin lesion
1%
Increased tendency to bruise
1%
Cyst rupture
1%
Glaucoma
1%
Ear congestion
1%
Neutropenia
1%
Septic shock
1%
Tumour lysis syndrome
1%
Ocular hyperaemia
1%
Duodenal ulcer
1%
Iron deficiency anaemia
1%
Ventricular septal defect
1%
Optic disc haemorrhage
1%
Infected bites
1%
Hyperaesthesia
1%
Pupillary light reflex tests abnormal
1%
Mucosal dryness
1%
Protein total increased
1%
Enterobacter infection
1%
Balance disorder
1%
Infection
1%
Aptyalism
1%
Blood urea increased
1%
Tinea pedis
1%
Lip injury
1%
Blood bilirubin increased
1%
Staphylococcal bacteraemia
1%
Skin irritation
1%
Nail discolouration
1%
Rash morbilliform
1%
Nail disorder
1%
Pharyngeal inflammation
1%
Nail bed inflammation
1%
Oral pruritus
1%
Cholangitis infective
1%
Cognitive disorder
1%
Musculoskeletal disorder
1%
Myasthenic syndrome
1%
Hypoglycaemia
1%
Haemarthrosis
1%
Micturition urgency
1%
Pyogenic granuloma
1%
Prurigo
1%
Psoriasis
1%
Acute myocardial infarction
1%
Chalazion
1%
Cataract
1%
Colour blindness acquired
1%
Tumour associated fever
1%
Cerumen impaction
1%
Presbyopia
1%
Retinopathy
1%
Subretinal fluid
1%
Oesophagitis
1%
Thrombophlebitis
1%
Hepatomegaly
1%
Pneumonia escherichia
1%
Blood phosphorus increased
1%
Seborrhoeic dermatitis
1%
Pharyngeal ulceration
1%
Onycholysis
1%
Neuropathy peripheral
1%
Neurotoxicity
1%
Nightmare
1%
Vitreous floaters
1%
Necrosis
1%
Aphasia
1%
Flushing
1%
Retinal deposits
1%
Retinal haemorrhage
1%
Vitreous detachment
1%
Lip dry
1%
Lip oedema
1%
Hepatic pain
1%
Breath sounds abnormal
1%
Haematoma
1%
Bundle branch block
1%
Xerosis
1%
Hepatic enzyme increased
1%
Skin ulcer
1%
Neuralgia
1%
Acute coronary syndrome
1%
Cor pulmonale acute
1%
Myocardial ischaemia
1%
Ulcerative keratitis
1%
Death
1%
Cholangitis
1%
Hepatotoxicity
1%
Bacteraemia
1%
Candida infection
1%
Device related infection
1%
Lower respiratory tract infection
1%
Staphylococcal sepsis
1%
Streptococcal sepsis
1%
Inguinal mass
1%
Epilepsy
1%
Metabolic encephalopathy
1%
Haemoptysis
1%
Skin toxicity
1%
Deep vein thrombosis
1%
Lymphadenitis
1%
Lymphocytosis
1%
Thrombocytosis
1%
Aortic valve stenosis
1%
Atrioventricular block second degree
1%
Diastolic dysfunction
1%
Pulmonary valve incompetence
1%
Sinus bradycardia
1%
Tachycardia
1%
Middle ear inflammation
1%
Adrenal insufficiency
1%
Blepharitis
1%
Conjunctival haemorrhage
1%
Cystoid macular oedema
1%
Deposit eye
1%
Diplopia
1%
Erythema of eyelid
1%
Eye oedema
1%
Eyelid haematoma
1%
Anal polyp
1%
Gastritis erosive
1%
Haematemesis
1%
Haematochezia
1%
Intestinal obstruction
1%
Mesenteric vein thrombosis
1%
Subileus
1%
Axillary pain
1%
Crying
1%
Enanthema
1%
Hyperpyrexia
1%
Hypothermia
1%
Inflammation
1%
Localised oedema
1%
Pain
1%
Papillitis
1%
Sensation of foreign body
1%
Sarcoidosis
1%
Conjunctivitis viral
1%
Fungal oesophagitis
1%
Fungal skin infection
1%
Gastroenteritis
1%
Helicobacter infection
1%
Klebsiella infection
1%
Lung infection
1%
Pulpitis dental
1%
Tinea versicolour
1%
Hypoaesthesia
1%
Muscle strain
1%
Optic nerve injury
1%
Rib fracture
1%
Scratch
1%
Wound complication
1%
Amylase increased
1%
Blood fibrinogen decreased
1%
Creatinine renal clearance decreased
1%
Electrocardiogram PR prolongation
1%
Electrocardiogram QRS complex prolonged
1%
Cell death
1%
Electrolyte imbalance
1%
Hyperamylasaemia
1%
Hyperlipasaemia
1%
Hyperphosphataemia
1%
Hypertriglyceridaemia
1%
Muscle contractions involuntary
1%
Increased appetite
1%
Iron deficiency
1%
Malnutrition
1%
Oligodipsia
1%
Arthritis
1%
Muscle spasms
1%
Muscle twitching
1%
Musculoskeletal chest pain
1%
Musculoskeletal discomfort
1%
Pain in jaw
1%
Blepharal papilloma
1%
Metastatic pain
1%
Peripheral motor neuropathy
1%
Agitation
1%
Depression
1%
Dyssomnia
1%
Euphoric mood
1%
Hallucination
1%
Persecutory delusion
1%
Renal vein occlusion
1%
Urinary incontinence
1%
Amenorrhoea
1%
Breast pain
1%
Haematospermia
1%
Pelvic pain
1%
Scrotal oedema
1%
Acute respiratory distress syndrome
1%
Asthma
1%
Bronchospasm
1%
Dry throat
1%
Hiccups
1%
Hypoventilation
1%
Lung disorder
1%
Orthopnoea
1%
Productive cough
1%
Rales
1%
Rhinalgia
1%
Throat irritation
1%
Decubitus ulcer
1%
Hair growth abnormal
1%
Hirsutism
1%
Pigmentation disorder
1%
Pruritus generalised
1%
Rash pruritic
1%
Skin erosion
1%
Toxic skin eruption
1%
Capillary leak syndrome
1%
Diastolic hypertension
1%
Pelvic venous thrombosis
1%
Peripheral coldness
1%
Myopia
1%
Venous thrombosis limb
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pimasertib
Pimasertib (Crossover)
Dacarbazine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (bintrafusp alfa, pimasertib)Experimental Treatment3 Interventions
Patients receive bintrafusp alfa IV over 1 hour every 2 weeks and pimasertib PO BID on days 1-28. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp Alfa
2021
Completed Phase 2
~40
Pimasertib
2021
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,773 Total Patients Enrolled
Hussein A TawbiPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
475 Total Patients Enrolled
Hussein A Tawbi, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Cancer Research Study Groups: Treatment (bintrafusp alfa, pimasertib)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes are researchers expecting to observe from this clinical trial?

"The chief objective of this trial, running from enrolment to intracranial progression (event) or the final follow-up date if there is no such event, and lasting up to two years, will be to ascertain a clinical benefit rate. Secondary aims include determining intracranial progression via modified RECIST 1.1 with Kaplan–Meier estimates and 95% confidence intervals; duration of response in patients who display extracral PR or CR according to RECIST 1.1 criteria along with median/range overall & within each group; as well as time to extracranial progression based on modified RECIST 1.1"

Answered by AI

How many individuals are partaking in this experiment?

"Unfortunately, this research trial is not admitting new participants. The medical study was initially published on the 15th of January 2021 and last updated on the 7th of September 2022. If you are in search for other studies, there exist 8878 trials seeking breast cancer patients as well as 22 clinical tests recruiting volunteers for Pimasertib treatment."

Answered by AI

What other explorations of Pimasertib have been undertaken in the clinical setting?

"Currently, 22 clinical trials are running studies on Pimasertib. Of those active investigations, two are in the final phase of development. Despite most research taking place in Houston, Texas; 285 sites across the world offer this medication for trial participants."

Answered by AI

Are there vacancies within this research project open to volunteers?

"The clinicaltrials.gov page reveals that this research trial is no longer recruiting participants, having first being made available on the 15th of January 2021 and last updated on 7th September 2022. However, there are 8900 other studies actively looking for volunteers at present."

Answered by AI

Is this the initial exploration of its type?

"Since 2016, Merck Sharp & Dohme LLC has sponsored extensive clinical trials of Pimasertib. Following an initial 829-person study in 2016, the drug was granted Phase 1 approval and currently there are 22 active studies occurring across 59 cities in 21 nations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases
2021. "Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04789668.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top