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Bintrafusp Alfa Continuation for Cancer

Phase 3
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
Participants currently on active bintrafusp alfa treatment alone or following discontinuation of other combination treatment agents in the parent study without treatment interruption
Participants who experienced a confirmed complete response (CR), partial response (PR), or stable disease (SD) in an eligible parent study and subsequently developed disease progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first treatment in parent study to planned final assessment at approximately up to 5 years
Awards & highlights

Study Summary

This trial is designed as a way for participants in other trials to continue to have access to the treatment and to provide long term data on safety and efficacy.

Who is the study for?
This trial is for patients already receiving bintrafusp alfa in other studies, without treatment interruption. It's open to those who've had stable disease or controlled side effects after stopping the drug, and are not pregnant nor have severe allergies to its ingredients. Participants must agree to use effective contraception.Check my eligibility
What is being tested?
The study provides ongoing access to bintrafusp alfa for lung cancer patients from previous trials and collects long-term data on its safety and effectiveness. Treatment continues until set criteria are met, it becomes commercially available, or the study ends.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants with well-controlled or resolved adverse events from prior bintrafusp alfa use can join. Those with permanent discontinuation due to certain immune-related issues or bleeding events cannot participate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently being treated with bintrafusp alfa, without any breaks.
Select...
My cancer initially responded to treatment but has now worsened.
Select...
My cancer is stable and I have no other treatment options.
Select...
I stopped taking bintrafusp alfa due to side effects, which are now under control or gone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first treatment in parent study to planned final assessment at approximately up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first treatment in parent study to planned final assessment at approximately up to 5 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
Occurrence of Adverse Events and Treatment-Related Adverse Events
Secondary outcome measures
Overall Survival (OS)

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%
Renal failure
1%
Type 1 diabetes mellitus
1%
Gastric ulcer haemorrhage
1%
Genital haemorrhage
1%
Brain abscess
1%
Radiation proctitis
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%
Spinal compression fracture
1%
Urinary retention
1%
Squamous cell carcinoma of skin
1%
Intermenstrual bleeding
1%
Cystitis radiation
1%
Female genital tract fistula
1%
Anal haemorrhage
1%
Immune-mediated thyroiditis
1%
Embolic stroke
1%
Hepatic function abnormal
1%
Asphyxia
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%
Hypovolaemic shock
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: 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?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,624 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,828 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,943 Total Patients Enrolled

Media Library

Bintrafusp alfa Clinical Trial Eligibility Overview. Trial Name: NCT05061823 — Phase 3
Lung Cancer Research Study Groups: Bintrafusp alfa
Lung Cancer Clinical Trial 2023: Bintrafusp alfa Highlights & Side Effects. Trial Name: NCT05061823 — Phase 3
Bintrafusp alfa 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061823 — Phase 3

Frequently Asked Questions

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

How many people are taking part in this experiment?

"That is correct. The clinicaltrials.gov website indicates that this study, which was first advertised on December 1st 2021, continues to actively recruit patients. They are looking for 42 individuals total from a single location."

Answered by AI

What are the precedents for this type of research?

"Bintrafusp alfa has had a long journey since 2016 when it was first studied. The very first clinical trial sponsored by Merck Sharp & Dohme LLC completed in that year with 829 participants. After the promising results of the initial study, Bintrafusp alfa received Phase 1 drug approval and is now being studied in 22 different trials taking place in 21 countries and 59 cities around the world."

Answered by AI

What are the potential risks of Bintrafusp alfa?

"Bintrafusp alfa is considered safe, as there is evidence from past Phase 3 trials to support this assertion."

Answered by AI

Are people still being recruited for this trial program?

"Per the information on clinicaltrials.gov, this trial is still looking for participants and was last updated on December 22nd, 2021. The study originally posted on December 1st, 2021 and is specifically recruiting 42 patients from a single site."

Answered by AI

Is this the first time Bintrafusp alfa has been tested in a controlled setting?

"At the moment, there are 22 on-going studies investigating Bintrafusp alfa with 2 at Phase 3. Most of these trials are situated in Henderson, Nevada; however, 285 different locations worldwide are running Bintrafusp alfa trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bintrafusp Alfa Program Rollover Study
2021. "Bintrafusp Alfa Program Rollover Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061823.
~9 spots leftby Apr 2025
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