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IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer
Phase 2 trial testing ALT-803 Subcutaneous in FIGO Stage III and IV Ovarian Cancer in 7 participants. Completed in 16 February 2022.
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 19 September 2017 |
| Primary completion | 16 February 2022 |
| Estimated completion | 16 February 2022 |
| Sites | 1 location across United States |
Masonic Cancer Center, University of Minnesota
18 and older, female only, with FIGO Stage III and IV Ovarian Cancer or FIGO Stage III and IV Fallopian Tube Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Progression Free Survival after first treatment of ALT-803.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: ALT-803 Subcutaneous Only | 50 | 1 – 91 |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous | 100 | 0 – 100 |
Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: ALT-803 Subcutaneous Only | 50 | 1 – 91 |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous | 100 | 0 – 100 |
Overall Survival from start of ALT-803 dosing
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: ALT-803 Subcutaneous Only | 100 | 0 – 100 |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous | 100 | 0 – 100 |
Incidence of ALT-803 associated toxicities after first treatment of ALT-803.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: ALT-803 Subcutaneous Only | 65 | |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous | 100 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: ALT-803 Subcutaneous Only | 1 | |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous | 2 |
Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: ALT-803 Subcutaneous Only | 50 | 1 – 91 |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous | 100 | 0 – 100 |
Overall Survival after first treatment of ALT-803.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: ALT-803 Subcutaneous Only | 100 | 0 – 100 |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous | 100 | 0 – 100 |
Time frame: Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 1: ALT-803 Subcutaneou… | Arm 2: ALT-803 Intraperito… |
|---|---|---|---|
| Syncope | Nervous system disorders | — | — |
| Reaction | System | Arm 1: ALT-803 Subcutaneou… | Arm 2: ALT-803 Intraperito… |
|---|---|---|---|
| Injection site reaction | General disorders | — | — |
| Chills | General disorders | — | — |
| Flu like symptoms | General disorders | — | — |
| Fever | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Pain | General disorders | — | — |
| Gait disturbance | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Fatigue | General disorders | — | — |
| General disorders and administration site conditions - Other, specify | General disorders | — | — |
| Localized edema | General disorders | — | — |
| Malaise | General disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Facial nerve disorder | Nervous system disorders | — | — |
| Peripheral motor neuropathy | Nervous system disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Erythroderma | Skin and subcutaneous tissue disorders | — | — |
| Hirsutism | Skin and subcutaneous tissue disorders | — | — |
| Telangiectasia | Skin and subcutaneous tissue disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Lymph node pain | Blood and lymphatic system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | — | — |
| Vestibular disorder | Ear and labyrinth disorders | — | — |
| Immune system disorders - Other, specify | Immune system disorders | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
Most-reported serious reactions: Syncope.
Data from ClinicalTrials.gov NCT03054909 adverse events section.
This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03054909.
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