Trial Outcomes & Findings for Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma (NCT NCT03399552)

Last Updated: 2023-10-23

Results Overview

defined by modified RECIST 1.1 for mesothelioma

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

3 years

Results posted on

2023-10-23

Participant milestones
Measure	Avelumab The treatment will consist of avelumab as well as a short course of Stereotactic Body Radiation Therapy
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Avelumab The treatment will consist of avelumab as well as a short course of Stereotactic Body Radiation Therapy
Overall Study No evidence of disease	1
Overall Study Unevaluable	1

Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma

Baseline characteristics by cohort
Measure	Avelumab n=15 Participants The treatment will consist of avelumab as well as a short course of Stereotactic Body Radiation Therapy
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 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	14 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	15 Participants n=5 Participants

Timeframe: 3 years

defined by modified RECIST 1.1 for mesothelioma

Outcome measures
Measure	Avelumab n=15 Participants The treatment will consist of avelumab as well as a short course of Stereotactic Body Radiation Therapy
Overall Response Rate Clinical Progression	2 Participants
Overall Response Rate Stable Disease	8 Participants
Overall Response Rate Partial Response	1 Participants
Overall Response Rate Non-evaluable	4 Participants

Serious events: 14 serious events

Other events: 14 other events

Deaths: 14 deaths

Serious adverse events
Measure	Avelumab n=15 participants at risk The treatment will consist of avelumab as well as a short course of Stereotactic Body Radiation Therapy
General disorders Death due to disease progression	13.3% 2/15 • 1 year
General disorders Death NOS	80.0% 12/15 • 1 year

Other adverse events
Measure	Avelumab n=15 participants at risk The treatment will consist of avelumab as well as a short course of Stereotactic Body Radiation Therapy
Injury, poisoning and procedural complications Infusion-related allergic reactions	40.0% 6/15 • 1 year
Metabolism and nutrition disorders Anorexia	40.0% 6/15 • 1 year
General disorders Fatigue	40.0% 6/15 • 1 year
Endocrine disorders Thyroid disorders	33.3% 5/15 • 1 year
Gastrointestinal disorders Diarrhea	20.0% 3/15 • 1 year
Musculoskeletal and connective tissue disorders Myalgia	20.0% 3/15 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	13.3% 2/15 • 1 year

Memorial Sloan Kettering Cancer Center

Phone: 646-608-2449