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Immunotherapy

Bintrafusp alfa for Cervical Cancer

Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
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 at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421, day 505 and day 589
Awards & highlights

Study Summary

This trial will test a new drug for people with cervical cancer that has progressed despite other treatment. Researchers will evaluate how well the drug works and how safe it is.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421, day 505 and day 589
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421, day 505 and day 589 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Secondary outcome measures
Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
+9 more

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%
Headache
8%
Oedema peripheral
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%
Pain
1%
Type 1 diabetes mellitus
1%
Lumbar vertebral fracture
1%
Spinal compression fracture
1%
Dyspnoea
1%
Urosepsis
1%
Haematoma
1%
Tumour haemorrhage
1%
Sepsis
1%
Urinary tract infection bacterial
1%
Malnutrition
1%
Erythema multiforme
1%
Squamous cell carcinoma of skin
1%
Brain abscess
1%
Hypovolaemic shock
1%
Radiation proctitis
1%
Cancer pain
1%
Altered state of consciousness
1%
Urinary retention
1%
Cystitis radiation
1%
Anal haemorrhage
1%
Immune-mediated thyroiditis
1%
Hepatic function abnormal
1%
Asphyxia
1%
Embolic stroke
1%
Pyelonephritis
1%
Venous thrombosis limb
1%
Renal failure
1%
Intermenstrual bleeding
1%
Drug-induced liver injury
1%
Bladder cancer
1%
Malaise
1%
Ureteral polyp
1%
Ileus
1%
Cholangitis acute
1%
Obstructive defaecation
1%
Hepatic pain
1%
Diabetic ketoacidosis
1%
Tumour pain
1%
Myasthenia gravis
1%
Urinary bladder haemorrhage
1%
Malignant ascites
1%
Secondary adrenocortical insufficiency
1%
Immune-mediated dermatitis
1%
Myositis
1%
Genital haemorrhage
1%
Gastric ulcer haemorrhage
1%
Malignant pleural effusion
1%
Female genital tract fistula
1%
Pulmonary thrombosis
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: Bintrafusp alfaExperimental Treatment1 Intervention
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?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,714 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,510 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,829 Total Patients Enrolled

Frequently Asked Questions

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

Has Bintrafusp alfa been tested through any other research initiatives?

"Initially evaluated at GSK Investigational Site during 2016, bintrafusp alfa has since been studied in a total of 4 trials. Currently, there are 22 active studies recruiting participants with many located in Stanford, California."

Answered by AI

Does this research exploration represent a unique approach?

"Since its inception in 2016, Bintrafusp alfa has been studied extensively. Merck Sharp & Dohme LLC spearheaded the first trial with 829 participants; this research was rewarded when it achieved Phase 1 drug approval. Presently, 22 clinical trials are underway for Bintrafusp alfa across 59 cities and 21 countries worldwide."

Answered by AI

How many separate venues are actively overseeing this experiment?

"This medical study is currently active at 11 different sites, including Stanford, Farmington Hills and Nashville. To reduce the travel burden of participating in this trial it is important to select a site as close to you as possible."

Answered by AI

Is admission for the clinical trial still available?

"This trial is no longer accepting volunteers. After being uploaded on March 30th 2020, the last amendment was made April 7th 2022. There are 317 studies looking for patients with uterine cervical neoplasms and 22 research projects recruiting participants to test out Bintrafusp alfa."

Answered by AI

What is the current cohort size of this medical investigation?

"This trial is no longer actively searching for candidates. The posting was first created on March 30th 2020 and last updated April 7th 2022. Those seeking alternative studies have 317 open trials looking for patients with uterine cervical neoplasms and 22 Bintrafusp alfa related clinical trials currently recruiting participants."

Answered by AI

Are there any potential adverse effects associated with Bintrafusp alfa?

"Although Phase 2, there is evidence that Bintrafusp alfa offers a safe experience for patients; thus it has been given an overall rating of 2."

Answered by AI
Recent research and studies
Science Translational MedicineJournal
Enhanced Preclinical Antitumor Activity of M7824, a Bifunctional Fusion Protein Simultaneously Targeting PD-L1 and Tgf-β
Lan, Yan, Dong Zhang, Chunxiao Xu, Kenneth W. Hance, Bo Marelli, Jin Qi, Huakui Yu, et al.. 2018. “Enhanced Preclinical Antitumor Activity of M7824, a Bifunctional Fusion Protein Simultaneously Targeting PD-L1 and Tgf-β”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.aan5488.
Clinical Cancer ResearchJournal
Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and Tgfβ, in Advanced Solid Tumors
Strauss, Julius, Christopher R. Heery, Jeffrey Schlom, Ravi A. Madan, Liang Cao, Zhigang Kang, Elizabeth Lamping, et al.. 2018. “Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and Tgfβ, in Advanced Solid Tumors”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-17-2653.
clinicaltrials.govStudy
Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
2020. "Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04246489.
~29 spots leftby Apr 2025
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