Trial Outcomes & Findings for BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) (NCT NCT04296942)
NCT ID: NCT04296942
Last Updated: 2022-01-11
Results Overview
Overall response is defined as the best response (Partial Response + Complete Response) recorded from the start of treatment until disease progression/recurrence assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
1 participants
Primary outcome timeframe
From start of treatment until disease progression/recurrence, approximately 5 months and 17 days.
Results posted on
2022-01-11
Participant Flow
Participant milestones
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)
Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)
Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
|---|---|---|---|
|
Overall Study
Study closure by sponsor
|
1
|
0
|
0
|
Baseline Characteristics
BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
Baseline characteristics by cohort
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
n=1 Participants
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)
Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 0 • n=5 Participants
|
—
|
—
|
44.4 years
STANDARD_DEVIATION 0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
—
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until disease progression/recurrence, approximately 5 months and 17 days.Population: This outcome measure pertains to Arm 1 TNBC participants only.
Overall response is defined as the best response (Partial Response + Complete Response) recorded from the start of treatment until disease progression/recurrence assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions.
Outcome measures
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
n=1 Participants
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
|---|---|---|---|
|
Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC)
Complete Response
|
0 Participants
|
—
|
—
|
|
Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC)
Partial Response
|
0 Participants
|
—
|
—
|
|
Overall Response (Partial Response + Complete Response) for Participants With Triple Negative Breast Cancer (TNBC)
Progressive Disease
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of treatment until disease progression/recurrence, approximately 5 months and 17 days.Population: This outcome measure pertains to Arm 2 and 3 only. Overall response in the HER2+ breast cancer cohort was not assessed as the study closed to accrual and no participants with HER2+ breast cancer was accrued.
Overall response is defined as the best response (Partial Response + Complete Response) recorded from the start of treatment until disease progression/recurrence. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progression is at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 5 months and 17 days.Population: No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
Adverse events were recorded using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
Outcome measures
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
n=1 Participants
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
|---|---|---|---|
|
Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents
Grade 3
|
0 Participants
|
—
|
—
|
|
Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents
Grade 4
|
0 Participants
|
—
|
—
|
|
Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events for Each of the Three Combinations of Agents
Grade 5
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days.Population: This outcome measure pertains to Arm 1 TNBC participants only.
Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. In the absence of progression or death, PFS is censored at the date of last disease evaluation. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions.
Outcome measures
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
n=1 Participants
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS) in Triple Negative Breast Cancer (TNBC)
|
63 Days
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days.Population: This outcome measure pertains to Arm 2 and 3 only. PFS in the HER2+ breast cancer cohort was not assessed as the study closed to accrual and no participants with HER2+ breast cancer was accrued.
Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. In the absence of progression or death, PFS is censored at the date of last disease evaluation. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, approximately 5 months and 17 days.Population: This outcome measure pertains to Arm 2 and 3 only. PFS in the HER2+ breast cancer cohort was not assessed as the study closed to accrual and no participants with HER2+ breast cancer was accrued.
Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. In the absence of progression or death, PFS is censored at the date of last disease evaluation. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions. appearance of new lesions. Appearance of one or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and on Cycle 3 Day 1Population: This outcome measure pertains to Arm 2 and 3 only. No participants with HER2+ metastatic breast cancer was accrued and thus outcome measure is not possible to determine.
The absolute percentage of stromal TILs was measured by the Salgado method in metastatic deposits in participants with metastatic HER2+ metastatic breast cancer. The Salgado method is a standardized approach for measuring the percentage of stromal TILs in primary breast tumor specimens before therapy, using visual assessment of standard hematoxylin and eosin (H\&E)-stained sections.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 5 months and 17 days.Population: No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
Here is the number of participants with serious and 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
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
n=1 Participants
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
1 Participants
|
—
|
—
|
Adverse Events
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1/M7824 (Bintrafusp Alfa) + Bavarian Nordic (BN)-Brachyury
n=1 participants at risk
Arm 1 - Triple Negative Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury.
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
2/M7824 + BN-Brachyury + Ado-trastuzumab Emtansine (T-DM1)
Arm 2 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
3/M7824 + BN-Brachyury + T-DM1 + Entinostat
Arm 3 - Estrogen receptor (ER)-/progesterone receptor (PR)-/Human Epidermal Growth Factor Receptor 2 (HER2)+ Breast Cancer.
Bifunctional fusion molecule involving programmed death-ligand 1 (PD-L1) with transforming growth factor beta (TGF-b) sequestering agent added to a vaccine for the tumor associated antigen called brachyury as well as to an oral histone deacetylase (HDAC) inhibitor called entinostat. These investigational agents will be added to standard of care treatment called Ado-trastuzumab emtansine (T-DM1). (T-DM1).
Brachyury-TRICOM: Every three weeks, until cycle 9, then every 12 weeks: \*Recombinant MVA-Bavarian Nordic (BN)-Brachyury recommended phase 2 dose (R2PD): 4 injections of vaccines with 1 given subcutaneous (SC) in each extremity on Day 1 of Cycles 1 and 2. Each injection of MVA-BN-Brachyury consists of 2.0 x 10\^8 infectious units (Inf.U). \*Recombinant fowlpox virus (FPV)-BN-Brachyury: 1 injection given SC in one extremity on Day 1 of Cycles 3 and beyond. Each injection of FPV-BN-Brachyury consists of 1.0 x 10\^9 Inf.U.
Entinostat: 5mg by mouth weekly (RP2D) administered by patient on Days 1, 8 and 15 of each cycle.
M7824: 1800mg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
Ado-trastuzumab emtansine: 3.6mg/kg via intravenous (IV) infusion every (q)3 weeks on Day 1 of each cycle.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Renal and urinary disorders
Hematuria
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
General disorders
Injection site reaction
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
—
0/0 • Date treatment consent signed to date off study, approximately 5 months and 17 days.
No participants were enrolled in group 2 and 3 due to study closure by the sponsor.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place