Trial Outcomes & Findings for IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer (NCT NCT03054909)

NCT ID: NCT03054909

Last Updated: 2023-10-13

Results Overview

Incidence of Progression Free Survival after first treatment of ALT-803.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

6 months

Results posted on

2023-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: ALT-803 Subcutaneous Only ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months

Population: survival probability estimate

Incidence of Progression Free Survival after first treatment of ALT-803.

Outcome measures

Outcome measures
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Progression Free Survival	50 Percentage of PFS Interval 1.0 to 91.0	100 Percentage of PFS Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 1 year

Population: survival probability estimate

Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate.

Outcome measures

Outcome measures
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Progression Free Survival	50 Percentage of participants Interval 1.0 to 91.0	100 Percentage of participants Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 1 year

Population: survival probability estimate

Overall Survival from start of ALT-803 dosing

Outcome measures

Outcome measures
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Overall Survival	100 Percentage of participants Interval 0.0 to 100.0	100 Percentage of participants Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 1 year

Population: Count of events

Incidence of ALT-803 associated toxicities after first treatment of ALT-803.

Outcome measures

Outcome measures
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
ALT-803 Associated Toxicities	65 Count of events	100 Count of events

SECONDARY outcome

Timeframe: 1 year

Population: Count of events

Grade 3 adverse events or greater will be measured. A Grade 3 adverse event is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling.

Outcome measures

Outcome measures
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Incidence of Recorded Toxicity Grade 3 or Greater	1 Number of of adverse events	2 Number of of adverse events

SECONDARY outcome

Timeframe: 2 years

Population: survival probability estimate

Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate.

Outcome measures

Outcome measures
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Progression Free Survival	50 Percentage of PFS Interval 1.0 to 91.0	100 Percentage of PFS Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 2 year

Population: Survival probability estimate

Overall Survival after first treatment of ALT-803.

Outcome measures

Outcome measures
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Overall Survival	100 Percentage of participants Interval 0.0 to 100.0	100 Percentage of participants Interval 0.0 to 100.0

Adverse Events

Arm 1: ALT-803 Subcutaneous Only

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 2: ALT-803 Intraperitoneal and Subcutaneous

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: ALT-803 Subcutaneous Only n=3 participants at risk ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 participants at risk ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
Nervous system disorders Syncope	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.

Other adverse events

Additional Information

Dr. Melissa Geller

University of Minnesota, Masonic Cancer Center

Phone: +1 612-626-3111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1: ALT-803 Subcutaneous Only n=3 Participants ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 Participants ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).	Total n=7 Participants Total of all reporting groups
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

Measure	Arm 1: ALT-803 Subcutaneous Only n=3 participants at risk ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)	Arm 2: ALT-803 Intraperitoneal and Subcutaneous n=4 participants at risk ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
General disorders Injection site reaction	100.0% 3/3 • Number of events 46 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	100.0% 4/4 • Number of events 48 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Chills	100.0% 3/3 • Number of events 25 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	100.0% 4/4 • Number of events 12 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Fever	66.7% 2/3 • Number of events 4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	75.0% 3/4 • Number of events 5 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Flu like symptoms	66.7% 2/3 • Number of events 3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	100.0% 4/4 • Number of events 8 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Pain	66.7% 2/3 • Number of events 4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Gait disturbance	66.7% 2/3 • Number of events 8 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	50.0% 2/4 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Fatigue	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders General disorders and administration site conditions - Other, specify	33.3% 1/3 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Localized edema	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
General disorders Malaise	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	75.0% 3/4 • Number of events 7 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Nervous system disorders Facial nerve disorder	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Nervous system disorders Peripheral motor neuropathy	33.3% 1/3 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Nervous system disorders Syncope	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	75.0% 3/4 • Number of events 4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	50.0% 2/4 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	50.0% 2/4 • Number of events 5 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	66.7% 2/3 • Number of events 3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Skin and subcutaneous tissue disorders Erythroderma	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Skin and subcutaneous tissue disorders Hirsutism	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Skin and subcutaneous tissue disorders Telangiectasia	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	50.0% 2/4 • Number of events 3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Blood and lymphatic system disorders Lymph node pain	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Ear and labyrinth disorders Vestibular disorder	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Immune system disorders Immune system disorders - Other, specify	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Infections and infestations Infections and infestations - Other, specify	33.3% 1/3 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Investigations Creatinine increased	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • Number of events 2 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	0.00% 0/4 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
Psychiatric disorders Anxiety	0.00% 0/3 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.	25.0% 1/4 • Number of events 1 • Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.