Trial Outcomes & Findings for 1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck (NCT NCT04150900)
NCT ID: NCT04150900
Last Updated: 2025-02-28
Results Overview
overall response rate
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 55 months.
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Bavituximab
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Bavituximab
n=7 Participants
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 55 months.overall response rate
Outcome measures
| Measure |
Pembrolizumab + Bavituximab
n=7 Participants
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
CR+PR
Progressive Disease
|
7 Participants
|
|
CR+PR
Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 55 months.Progression free survival
Outcome measures
| Measure |
Pembrolizumab + Bavituximab
n=7 Participants
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
Progression
Progressive Disease
|
7 Participants
|
|
Progression
Progression Free Survival
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression up to 100 weeksNumber of participants with disease progression. For duration of response, CT imaging and RECIST criteria were reviewed to measure patient's response and time of that duration. One cycle is 21 days.
Outcome measures
| Measure |
Pembrolizumab + Bavituximab
n=7 Participants
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
Disease Progression
Progression prior to Cycle 2
|
1 Participants
|
|
Disease Progression
Progression at Cycle 2
|
2 Participants
|
|
Disease Progression
Progression at Cycle 3
|
3 Participants
|
|
Disease Progression
Progression at Cycle 4
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 55 months.Overall survival
Outcome measures
| Measure |
Pembrolizumab + Bavituximab
n=7 Participants
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
Survival
Outcome Unknown
|
1 Participants
|
|
Survival
Patient Expired
|
6 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearNumber of participants with laboratory correlates of response. The following outcomes are being measured: PD-L1 expression pre and post treatment Presence of TILs (tumor infiltrating lymphocytes) pre and post treatment Assessment of immune markers in pre-treatment fresh and post-treatment biopsies and blood. Assessment of genomics and tumor mutation burden in select patients. These outcome measures are determined through archival tumor tissue and next generation sequencing.
Outcome measures
| Measure |
Pembrolizumab + Bavituximab
n=7 Participants
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
Participants With Laboratory Correlates of Response
Laboratory correlates of response
|
0 Participants
|
|
Participants With Laboratory Correlates of Response
No Laboratory correlates of response
|
7 Participants
|
Adverse Events
Pembrolizumab + Bavituximab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pembrolizumab + Bavituximab
n=7 participants at risk
Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck
Bavituximab: Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
Pembrolizumab: Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
|
|---|---|
|
General disorders
Fatigue
|
42.9%
3/7 • 55 months
|
|
General disorders
Back Pain
|
14.3%
1/7 • 55 months
|
|
General disorders
Bilateral Lower limb edema
|
14.3%
1/7 • 55 months
|
|
General disorders
Bleeding of lower lip
|
14.3%
1/7 • 55 months
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • 55 months
|
|
General disorders
Digital pain/rash
|
14.3%
1/7 • 55 months
|
|
General disorders
Dizziness
|
28.6%
2/7 • 55 months
|
|
General disorders
Dry Cough
|
14.3%
1/7 • 55 months
|
|
General disorders
Dysegeusia
|
14.3%
1/7 • 55 months
|
|
General disorders
Dysphagia
|
14.3%
1/7 • 55 months
|
|
General disorders
Epistaxis
|
14.3%
1/7 • 55 months
|
|
General disorders
Eye Irritation
|
14.3%
1/7 • 55 months
|
|
General disorders
Facial Edema
|
14.3%
1/7 • 55 months
|
|
General disorders
Fever
|
14.3%
1/7 • 55 months
|
|
General disorders
Headache
|
28.6%
2/7 • 55 months
|
|
Blood and lymphatic system disorders
Hypergylcemia
|
14.3%
1/7 • 55 months
|
|
General disorders
Infection of lower lip
|
14.3%
1/7 • 55 months
|
|
General disorders
Inflammation of lip
|
14.3%
1/7 • 55 months
|
|
General disorders
Intermittent Fever
|
14.3%
1/7 • 55 months
|
|
General disorders
Intermittent Non-Cardiac Chest pain
|
14.3%
1/7 • 55 months
|
|
General disorders
Joint Pain
|
14.3%
1/7 • 55 months
|
|
General disorders
Nausea
|
28.6%
2/7 • 55 months
|
|
General disorders
Neuropathic Neck Pain
|
14.3%
1/7 • 55 months
|
|
General disorders
non-Cardiac Upper chest wall pain
|
14.3%
1/7 • 55 months
|
|
General disorders
Odynophagia
|
14.3%
1/7 • 55 months
|
|
General disorders
Pharyngeal Cutaneous fistual
|
14.3%
1/7 • 55 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
14.3%
1/7 • 55 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
14.3%
1/7 • 55 months
|
|
General disorders
Stomach Pain
|
14.3%
1/7 • 55 months
|
|
General disorders
Weight loss
|
14.3%
1/7 • 55 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place