Trial Outcomes & Findings for Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer (NCT NCT04220775)
NCT ID: NCT04220775
Last Updated: 2024-11-07
Results Overview
For the phase I part of this phase I/II study, the primary endpoint was DLT defined as any grade 3 or above AE resulting in inability to complete radiotherapy due to toxicity related to M7824 or the combination of M7824 and SBRT.
TERMINATED
PHASE1/PHASE2
3 participants
The DLT window is from first M7824 dose (D0) until 14 days post SBRT (D28).
2024-11-07
Participant Flow
3 participants were registered, 1 participants were not treated, not eligible or inevaluable, Participant withdrew before screening completed.
The study was planned to enroll 8 patients in phase 1 to assess safety and toxicity. However, based on sponsored analytical findings of other trials using this drug the sponsor decided to no longer develop the drug and stop support of studies using the drug. The study was ended early. Three participants were registered, 2 of them were treated and 1 of them withdrew before screening completed.
Participant milestones
| Measure |
Phase 1 Bintrafusp Alfa + SBRT
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Phase 2 Bintrafusp Alfa + SBRT
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Phase 1 Bintrafusp Alfa + SBRT
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Phase 2 Bintrafusp Alfa + SBRT
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
Baseline Characteristics
Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 Bintrafusp Alfa + SBRT
n=2 Participants
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
60.4 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: The DLT window is from first M7824 dose (D0) until 14 days post SBRT (D28).Population: The two participants who were enrolled in phase 1 part of the study.
For the phase I part of this phase I/II study, the primary endpoint was DLT defined as any grade 3 or above AE resulting in inability to complete radiotherapy due to toxicity related to M7824 or the combination of M7824 and SBRT.
Outcome measures
| Measure |
Phase 1 Bintrafusp Alfa + SBRT
n=2 Participants
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Phase 2 Bintrafusp Alfa + SBRT
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Dose Limiting Toxicity (DLT)
DLT
|
0 Participants
|
0 Participants
|
|
Dose Limiting Toxicity (DLT)
No DLT
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The study was terminated after enrollment of 2 participants in phase 1 and no participants participated in the phase II part of this study.
For the phase II part of this phase I/II study, the primary endpoint was to evaluate progression-free survival (PFS) at 1 year. Progression-free survival was defined as from treatment start to progression, or death, whichever occurred first, or to the last follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Tumor reassessment during treatmentPopulation: The study was terminated after enrollment of 2 patients in phase 1 and no patient participated in the phase II part of this study.
Best overall response by RECIST 1.1
Outcome measures
| Measure |
Phase 1 Bintrafusp Alfa + SBRT
n=2 Participants
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
Phase 2 Bintrafusp Alfa + SBRT
Participants receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response by RECIST
Partial response
|
1 Participants
|
0 Participants
|
|
Overall Response by RECIST
Progressive disease
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: This was a secondary outcome in phase 2 only. The study was terminated after enrollment of 2 patients in phase 1 and no patient participated in the phase 2 part of this study. This outcome was not analyzed because no patient was recruited in phase 2.
OS was defined was from treatment start to death or to the last follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: This was a secondary outcome in phase 2 only. The study was terminated after enrollment of 2 patients in phase 1 and no patient participated in the phase 2 part of this study. This outcome was not analyzed because no patient was recruited in phase 2.
Common Terminology Criteria for Adverse Events (CTCAE)-v5.0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearPopulation: This was a secondary outcome in phase 2 only. The study was terminated after enrollment of 2 patients in phase 1 and no patient participated in the phase 2 part of this study. This outcome was not analyzed because no patient was recruited in phase 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearPopulation: This was a secondary outcome in phase 2 only. The study was terminated after enrollment of 2 patients in phase 1 and no patient participated in the phase 2 part of this study. This outcome was not analyzed because no patient was recruited in phase 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearPopulation: This was a secondary outcome in phase 2 only. The study was terminated after enrollment of 2 patients in phase 1 and no patient participated in the phase 2 part of this study. This outcome was not analyzed because no patient was recruited in phase 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 yearPopulation: This was a secondary outcome in phase 2 only. The study was terminated after enrollment of 2 patients in phase 1 and no patient participated in the phase 2 part of this study. This outcome was not analyzed because no patient was recruited in phase 2.
Outcome measures
Outcome data not reported
Adverse Events
Bintrafusp Alfa + SBRT
Serious adverse events
| Measure |
Bintrafusp Alfa + SBRT
n=2 participants at risk
Patients receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Insufficiency
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Lipase increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Bintrafusp Alfa + SBRT
n=2 participants at risk
Patients receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 2 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
2/2 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
100.0%
2/2 • Number of events 2 • 2 years
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Investigations - Other, specify (Amylase Increased)
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Investigations - Other, specify (Bilirubin Increased)
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Investigations
Lipase increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (Osteoarthritis)
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (Lichen planus of tongue)
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify (N/A)
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Number of events 2 • 2 years
|
|
Investigations
Serum amylase increased
|
50.0%
1/2 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place