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Monoclonal Antibodies

Bintrafusp alfa for Tumors

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
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 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug for people with urothelial cancer that has progressed after other treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Confirmed overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 assessed by Investigator
Secondary outcome measures
Number of participants with AEs by their severity
Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Side effects data

From 2022 Phase 2 trial • 146 Patients • NCT04246489
55%
Anaemia
21%
Nausea
18%
Haematuria
17%
Pyrexia
16%
Decreased appetite
16%
Asthenia
16%
Rash
15%
Constipation
14%
Vomiting
14%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
12%
Hypothyroidism
12%
Gingival bleeding
12%
Pruritus
10%
Urinary tract infection
10%
Fatigue
10%
Hypoalbuminaemia
9%
Cough
8%
Diarrhoea
8%
Abdominal pain
8%
Oedema peripheral
8%
Headache
8%
Disease progression
8%
Hypokalaemia
8%
Insomnia
8%
Vaginal haemorrhage
7%
Hyperthyroidism
7%
Blood alkaline phosphatase increased
7%
Stomatitis
7%
Lipase increased
7%
Back pain
6%
Blood creatinine increased
5%
Weight decreased
5%
Hyponatraemia
5%
Arthralgia
5%
Amylase increased
3%
Pulmonary embolism
3%
General physical health deterioration
3%
Colitis
2%
Hydronephrosis
2%
Acute kidney injury
1%
Abdominal sepsis
1%
Pyelonephritis
1%
Pain
1%
Type 1 diabetes mellitus
1%
Gastric ulcer haemorrhage
1%
Genital haemorrhage
1%
Pulmonary thrombosis
1%
Dyspnoea
1%
Secondary adrenocortical insufficiency
1%
Sepsis
1%
Urinary tract infection bacterial
1%
Urosepsis
1%
Lumbar vertebral fracture
1%
Malnutrition
1%
Myositis
1%
Altered state of consciousness
1%
Erythema multiforme
1%
Brain abscess
1%
Hypovolaemic shock
1%
Radiation proctitis
1%
Urinary retention
1%
Cystitis radiation
1%
Anal haemorrhage
1%
Immune-mediated thyroiditis
1%
Hepatic function abnormal
1%
Asphyxia
1%
Spinal compression fracture
1%
Squamous cell carcinoma of skin
1%
Embolic stroke
1%
Female genital tract fistula
1%
Renal failure
1%
Intermenstrual bleeding
1%
Cancer pain
1%
Drug-induced liver injury
1%
Bladder cancer
1%
Malaise
1%
Malignant ascites
1%
Ureteral polyp
1%
Immune-mediated dermatitis
1%
Venous thrombosis limb
1%
Ileus
1%
Cholangitis acute
1%
Obstructive defaecation
1%
Hepatic pain
1%
Diabetic ketoacidosis
1%
Tumour haemorrhage
1%
Malignant pleural effusion
1%
Tumour pain
1%
Myasthenia gravis
1%
Urinary bladder haemorrhage
1%
Haematoma
1%
Metastases to spine
1%
Blood loss anaemia
1%
Pancreatitis
1%
Mouth ulceration
1%
Adrenal insufficiency
1%
Septic arthritis streptococcal
1%
Dental caries
1%
Gastric haemorrhage
1%
Malignant gastrointestinal obstruction
1%
Inappropriate antidiuretic hormone secretion
1%
Pyelonephritis acute
1%
Brain oedema
1%
Pathological fracture
1%
Deep vein thrombosis
1%
Intestinal fistula infection
1%
Febrile neutropenia
1%
Cardiac failure
1%
Pancreatitis acute
1%
Rectal haemorrhage
1%
Subileus
1%
Kidney infection
1%
Lung abscess
1%
Stoma obstruction
1%
Transaminases increased
1%
Neuritis
1%
Polyneuropathy in malignant disease
1%
Device dislocation
1%
Cystitis haemorrhagic
1%
Haemorrhage urinary tract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bintrafusp Alfa

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants receiving bintrafusp alfaExperimental Treatment1 Intervention
Participants will receive bintrafusp alfa.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp alfa
2020
Completed Phase 2
~1110

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,447 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,631 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,905 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors

Frequently Asked Questions

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

Are there any North American locations conducting this clinical investigation?

"At present, this clinical trial is operating in 6 different locations, such as Toronto, Cincinnati and Seattle. It would be best for participants to choose the closest medical centre to reduce travel requirements."

Answered by AI

What is the main aim of this research?

"According to the information released by Merck KGaA, Darmstadt, Germany, this clinical trial's primary objective will be measured over three years and is defined as Confirmed overall response rate (ORR) - Investigator assessment. Additionally, secondary outcomes being evaluated include Number of participants with positive anti-drug antibodies (ADAs), Percentage of participants with positive ADAs against bintrafusp alfa, and Concentration observed immediately before next dosing for bintrafusp alfa."

Answered by AI

Is this medical experiment the initial of its kind?

"Since its inception in 2016, the research into Bintrafusp alfa has been sponsored by Merck Sharp & Dohme LLC. This led to a phase 1 drug approval for 829 patients and currently there are active investigations of this medication occurring in 21 different countries with 59 cities participating."

Answered by AI

What other scientific investigations have focused on Bintrafusp alfa?

"Currently, 22 studies exploring Bintrafusp alfa are live with 2 of them in Phase 3. Though the bulk of these clinical trials occur in Henderson, Nevada, there exist a total of 285 locations conducting research on this drug."

Answered by AI

Has the FDA officially sanctioned Bintrafusp alfa?

"The safety of Bintrafusp alfa is calculated to be a 1 on our company's rating system, as this clinical trial is in its early stages and has very limited data on the efficacy and safety."

Answered by AI

How many patients have been enlisted for this research endeavor?

"This experiment is no longer accepting applicants as the last modification to its listing was made on September 22nd 2022. Nevertheless, there are several other clinical trials still open for patients with cancer (2380) and Bintrafusp alfa (22)."

Answered by AI

Are there any open slots available for this research project?

"The clinical trial registry on clinicialtrials.gov suggests that this particular study, which was first announced on October 15th 2020 and last updated September 22nd 2022, is not presently searching for participants. Nevertheless, 2401 other studies are actively recruiting now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer
2020. "A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04349280.
~6 spots leftby Apr 2025
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