Trial Outcomes & Findings for Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma (NCT NCT05005429)
NCT ID: NCT05005429
Last Updated: 2025-12-23
Results Overview
To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 as an increase of at least 20%in the sumof thediameters of viable (enhancing) target lesions, taking as reference the smallest sumof thediameters of the viable (enhancing) target lesions. The sum must also demonstrate an absoluteincrease of at least 5 mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years.
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
Experimental: Bintrafusp Alfa (M7824)
Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals .
Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
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|---|---|
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Overall Study
STARTED
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47
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Overall Study
COMPLETED
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46
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Experimental: Bintrafusp Alfa (M7824)
n=46 Participants
Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals .
Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
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|---|---|
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Sex: Female, Male
Female
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10 Participants
n=68 Participants
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Sex: Female, Male
Male
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36 Participants
n=68 Participants
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|
Age, Continuous
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70 years
n=68 Participants
|
|
Race/Ethnicity, Customized
Caucasian
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45 Participants
n=68 Participants
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Race/Ethnicity, Customized
Latin
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1 Participants
n=68 Participants
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Smoking habit
Never smoker (<= 100 cigarettes/lifetime)
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18 Participants
n=68 Participants
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Smoking habit
Former smoker (>= 1 year)
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22 Participants
n=68 Participants
|
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Smoking habit
Active smoker
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6 Participants
n=68 Participants
|
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Lines of therapy
Second (received at least 1 previous line)
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39 Participants
n=68 Participants
|
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Lines of therapy
Third (received two previous lines)
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7 Participants
n=68 Participants
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PRIMARY outcome
Timeframe: From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years.Population: 47 patients were enrolled in the study although patient 05000013 was finally considered as inclusion error and did not enter in the analysis.
To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 as an increase of at least 20%in the sumof thediameters of viable (enhancing) target lesions, taking as reference the smallest sumof thediameters of the viable (enhancing) target lesions. The sum must also demonstrate an absoluteincrease of at least 5 mm.
Outcome measures
| Measure |
Experimental: Bintrafusp Alfa (M7824)
n=46 Participants
Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals .
Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
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|---|---|
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To Evaluate the Efficacy of the Treatment
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1.9 Months
Interval 1.7 to 5.4
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Adverse Events
Experimental: Bintrafusp Alfa (M7824)
Serious events: 22 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Bintrafusp Alfa (M7824)
n=46 participants at risk
Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals .
Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
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|---|---|
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Renal and urinary disorders
Acute kidney injury
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Endocrine disorders
Adrenal insufficiency
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4.3%
2/46 • Number of events 2 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Immune system disorders
Allergic reaction
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Blood and lymphatic system disorders
Anemia
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19.6%
9/46 • Number of events 9 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Gastrointestinal disorders
Colitis
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Skin and subcutaneous tissue disorders
Pruritus
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4.3%
2/46 • Number of events 2 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Skin and subcutaneous tissue disorders
Rash maculo-papular
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Skin and subcutaneous tissue disorders
Eczema
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4.3%
2/46 • Number of events 2 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Skin and subcutaneous tissue disorders
Oher
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6.5%
3/46 • Number of events 3 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Other adverse events
| Measure |
Experimental: Bintrafusp Alfa (M7824)
n=46 participants at risk
Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals .
Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
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|---|---|
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Blood and lymphatic system disorders
Anemia
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10.9%
5/46 • Number of events 5 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Gastrointestinal disorders
Diarrhea
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Gastrointestinal disorders
Colitis
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Immune system disorders
Allergic reaction
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Investigations
Lipase increased
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Investigations
Serum amylase increased
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2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
|
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Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.3%
2/46 • Number of events 2 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
|
|
Endocrine disorders
Adrenal Insufficiency
|
2.2%
1/46 • Number of events 1 • Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place