Trial Outcomes & Findings for Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL) (NCT NCT02494206)

Last Updated: 2018-11-08

Results Overview

Therapeutic volume changes in the arm will be calculated using the methods published by Anderson et al (2000).65 Briefly, the difference in volume measurements between the normal and lymphedematous arms at baseline (i.e volume excess) will be compared to the volume differential after drug treatment and following the washout period using the following formula: (VL-VN) B - (VL-VN) F

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

1 year

Results posted on

2018-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL). QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL). QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.
Overall Study Adverse Event	1
Overall Study Disease Progression	1

Baseline Characteristics

Immunotherapy for the Treatment of Breast Cancer Related Upper Extremity Lymphedema (BCRL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) n=9 Participants This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL). QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 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	0 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	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

QBX258 (VAK694 3mg/kg and QAX576 6mg/kg)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) n=9 participants at risk This will be a single arm, open label design pilot study, aiming to test the efficacy of QBX258, a combination of two fully human monoclonal antibodies that neutralize the biologic activity of interleukin 4 and interleukin 13 (IL4/IL13), for the treatment of stage I or II breast cancer related upper extremity lymphedema (BCRL). QBX258: Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.
Infections and infestations Skin infection/cellulitis	11.1% 1/9 • 1 year
Injury, poisoning and procedural complications Fracture	11.1% 1/9 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec	11.1% 1/9 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Babak Mehrara MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-3099

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place