Trial Outcomes & Findings for Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection (NCT NCT04247282)

Last Updated: 2025-07-16

Results Overview

Resected tumors were reviewed one month after being on study to determine a pCR, defined as absence of malignant cells in the resected tumor specimen. A pathologist examines tumor specimens to look for malignant cells.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Post treatment after on study, approximately one month

Results posted on

2025-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15) Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Enrolled But Not Treated Participant was enrolled but not treated.
Overall Study STARTED	14	6	1
Overall Study COMPLETED	14	5	0
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15) Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Enrolled But Not Treated Participant was enrolled but not treated.
Overall Study Participant declined to participate before treatment started.	0	0	0	1
Overall Study Refused further treatment	0	1	0	0

Baseline Characteristics

Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Enrolled But Not Treated n=1 Participants Participant was enrolled but not treated.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	3 Participants n=7 Participants	—	1 Participants n=4 Participants	12 Participants n=21 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	—	0 Participants n=4 Participants	9 Participants n=21 Participants
Age, Continuous	59.54 years STANDARD_DEVIATION 13.38 • n=5 Participants	60.3 years STANDARD_DEVIATION 18.41 • n=7 Participants	—	48 years STANDARD_DEVIATION 0 • n=4 Participants	59.2 years STANDARD_DEVIATION 14.41 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	—	0 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	1 Participants n=7 Participants	—	1 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	—	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	4 Participants n=7 Participants	—	1 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	—	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	—	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	4 Participants n=7 Participants	—	1 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	14 participants n=5 Participants	6 participants n=7 Participants	—	1 participants n=4 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: Post treatment after on study, approximately one month

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started.

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Number of Participants Who Experience a Pathologic Complete Response (pCR)	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: up to 4 months after enrollment

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started.

Clinical-to-pathologic downstaging is when the numerical pathological stage is lower than the initial numerical clinical stage (i.e., II to I)

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Number of Participants Who Experience Clinical to Pathologic Downstaging Upon Analysis of Resected Tumor After Completing Study Treatments	6 Participants	2 Participants	—

SECONDARY outcome

Timeframe: 21-28 days from enrollment, up to a maximum of 28 days

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started.

Response was measured by CT imaging and the RECIST to determine whose tumors shrunk after therapy. CR is disappearance of all target lesions, and PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Proportion of Participants With a Complete Response (CR) + Partial Response (PR) Measured by Computed Tomography (CT) Imaging and the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	0 proportion of participants	0 proportion of participants	—

SECONDARY outcome

Timeframe: 2 weeks

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started.

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 is severe. Grade 4 is life-threatening. Permanent treatment discontinuation is required in some cases of immune-related Grade 4 AEs (e.g., Grade 4 rash/inflammatory dermatitis, nephritis,..). Permanent treatment discontinuation is not required when the AE is manifested by a single laboratory value out of normal range without any clinical correlates.

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Number of Participants That Experienced Grade 3 or 4 Immune Related Adverse Events (irAEs) Grade 3 Vasculitis	1 Participants	0 Participants	—
Number of Participants That Experienced Grade 3 or 4 Immune Related Adverse Events (irAEs) Grade 4 Pneumonitis	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 1 and 2 years

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started.

Probability of being alive and recurrence (disease) free after treatment reported along with 95% confidence intervals. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Disease recurrence is defined as the cancer comes back evidenced by imaging, clinical exam and/or biopsy.

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Probability of Being Alive and Recurrence Free 1 year	84.6 percent probability Interval 51.2 to 95.9	83.3 percent probability Interval 27.3 to 97.5	—
Probability of Being Alive and Recurrence Free 2 years	84.6 percent probability Interval 51.2 to 95.9	83.3 percent probability Interval 27.3 to 97.5	—

SECONDARY outcome

Timeframe: Participants were followed to see if they were alive and recurrence free for up to 2 years from study enrollment.

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started. The data reported is observed data.

Participants who are alive after therapy reported along with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Percentage of Participants Who Are Alive 1 year	92.3 percentage of participants Interval 56.6 to 98.9	83.3 percentage of participants Interval 27.3 to 97.5	—
Percentage of Participants Who Are Alive 2 years	84.6 percentage of participants Interval 51.2 to 95.9	83.3 percentage of participants Interval 27.3 to 97.5	—

SECONDARY outcome

Timeframe: 4 weeks or more beyond surgery, up to 2 years

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started.

Here is the number of participants with treatment-related adverse events causing a delay of 4 weeks or more beyond planned surgery. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Number of Participants With Treatment-related Adverse Events Causing a Delay of 4 Weeks or More Beyond Planned Surgery	0 Participants	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 2 years and 12 days for Arm A, and 2 months and 29 days for Arm B.

Population: 20/21 participants were analyzed because one participant declined to participate before treatment started.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15) n=14 Participants Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 Participants Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	14 Participants	6 Participants	—

Adverse Events

Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15)

Serious events: 2 serious events

Other events: 14 other events

Deaths: 2 deaths

Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15) n=14 participants at risk Phase I/II M7824 (Days 1, 15) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).	Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1) n=6 participants at risk Phase I/II M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3	Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1) Phase I/II No participants were enrolled on Arm C, Cohort 1. M7824 + TriAd vaccine (Day 1) + N-803 (Day 1) M7824: M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms). N803: N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3. TriAd vaccine: TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
Cardiac disorders Cardiac arrest	0.00% 0/14 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	16.7% 1/6 • Number of events 1 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	— 0/0 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/14 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	16.7% 1/6 • Number of events 1 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	— 0/0 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.
Cardiac disorders Sinus tachycardia	7.1% 1/14 • Number of events 1 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	0.00% 0/6 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	— 0/0 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.
Vascular disorders Vasculitis	7.1% 1/14 • Number of events 1 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	0.00% 0/6 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.	— 0/0 • All adverse events (AEs), including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. From first study intervention day 1 to 30 days after participant received the last product administration. After 90 days, only adverse events grade ≥3 & possibly related to the study investigational agent need to be recorded. Approximately 2 years & 12 days for Arm A, and 2 months & 29 days for Arm B. 20/21 participants were analyzed because one participant declined to participate before treatment started. And no participants were enrolled in Arm C.

Other adverse events

Additional Information

Dr. Hoyoung Maeng

National Cancer Institute

Phone: 240-781-3253

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place