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Immunostimulant

ALT-803 for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By John Wrangle, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to time of documented date of death assessed up to 3 years

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new drug combination for people with lung cancer that has spread and cannot be removed with surgery.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to time of documented date of death assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to time of documented date of death assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of documented date of death assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Presence or absence of a dose limiting toxicity (DLT) of ALT-803 in combination with Nivolumab

Response Rate

Secondary outcome measures

Change in frequency of NK cells resulting from ALT-803 administration

Change in frequency of T cells resulting from ALT-803 administration

Body Weight Changes

+6 more

Side effects data

From 2019 Phase 2 trial • 8 Patients • NCT03050216

88%

Chills

88%

Injection site reaction

75%

Headache

63%

Fever

63%

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other

50%

Fatigue

50%

Febrile neutropenia

50%

Hypertension

50%

Hypotension

38%

Infusion related reaction

25%

Dizziness

25%

Hypoxia

25%

Pain

25%

Skin and subcutaneous tissue disorders - Other

13%

Gastroesophageal reflux disease

13%

Rash maculo-papular

13%

Anxiety

13%

Adult respiratory distress syndrome

13%

Dyspnea

13%

Diarrhea

13%

Nervous system disorders - Other

13%

Oral pain

13%

Myalgia

13%

Cough

13%

Hypophosphatemia

13%

Generalized muscle weakness

13%

Vomiting

13%

Aspartate aminotransferase increased

13%

Sepsis

13%

Clostridium Difficile Infection

13%

Alanine aminotransferase increased

13%

Febrile neutropenia - Changed to levaquin and micafungin

13%

Heart failure

13%

Lung infection

13%

Tumor lysis syndrome

13%

Acute kidney injury

13%

Disseminated intravascular coagulation

13%

Atrial fibrillation

13%

Constipation

13%

Blood bilirubin increased

13%

Urine output decreased

13%

Anorexia

13%

Hypoalbuminemia

13%

Hypocalcemia

100%

80%

60%

40%

20%

Study treatment Arm

Cy, FLU, Haplo NK and ALT-803

Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm B: ALT-803 + Nivolumab progressorExperimental Treatment2 Interventions

Patients who have had PD-1 blockade (nivolumab, pembrolizumab, or atezolizumab) and progressed will be enrolled to Arm B in the Phase II part of the study. ALT-803 will be administered on Day 1 of weeks 1-5 of each cycle for up to 4 cycles. During week 6 no study drug will be administered. ALT-803 will be administered at the recommended phase II dose of 20mcg/kg. Nivolumab will be administered Day 1 of every other week of each cycle starting with week 1 (Week 1, Week 3, Week 5).The dose level for Nivolumab is 240mg.

Group II: Arm A: ALT-803 + Nivo naiveExperimental Treatment2 Interventions

Patients who have not received PD-1 blockade (nivolumab, pembrolizumab, or atezolizumab) will be enrolled to Arm A in the Phase II part of the study. ALT-803 will be administered on Day 1 of weeks 1-5 of each cycle for up to 4 cycles. During week 6 no study drug will be administered. ALT-803 will be administered at the recommended phase II dose of 20mcg/kg. Nivolumab will be administered Day 1 of every other week of each cycle starting with week 1 (Week 1, Week 3, Week 5).The dose level for Nivolumab is 240mg.

Group III: ALT-803 + Nivolumab dose escalationExperimental Treatment2 Interventions

Up to 21 patients will receive ALT-803 + Nivolumab in the dose escalation phase to determine the maximum tolerated dose. ALT-803 will be administered on Day 1 of weeks 1-5 of each cycle for up to 4 cycles. During week 6 no study drug will be administered. The starting dose level for ALT-803 is 6 microgram (mcg)/kilogram (kg); the second dose level is 10 mcg/kg; the third dose level is 15 mcg/kg; and the fourth dose level is 20 mcg/kg. Nivolumab will be administered Day 1 of every other week of each cycle starting with week 1 (Week 1, Week 3, Week 5).The dose level for Nivolumab is 240mg.

Group IV: ALT-803 + Nivolumab Exploratory Arm 2Experimental Treatment2 Interventions

All eligible patients will be enrolled into one of two exploratory dosing arms. For exploratory Arm 1: The dose level for ALT-803 is 10 mcg/kg. ALT-803 will be administered Day 1 of every other week of each cycle starting with week 1 (Week 1, Week 3, Week 5) for up to 4 cycles. Nivolumab will be administered Day 1 of every other week of each cycle starting with week 1 (Week 1, Week 3, Week 5).The dose level for Nivolumab is 240mg.

Group V: ALT-803 + Nivolumab Exploratory Arm 1Experimental Treatment2 Interventions

All eligible patients will be enrolled into one of two exploratory dosing arms. For exploratory Arm 1: The dose level for ALT-803 is 20 mcg/kg. ALT-803 will be administered Day 1 of every other week of each cycle starting with week 1 (Week 1, Week 3, Week 5) for up to 4 cycles. Nivolumab will be administered Day 1 of every other week of each cycle starting with week 1 (Week 1, Week 3, Week 5).The dose level for Nivolumab is 240mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALT-803

2016

Completed Phase 2

~170

Nivolumab

2014

Completed Phase 3

~4750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Altor BioScienceIndustry Sponsor

17 Previous Clinical Trials

538 Total Patients Enrolled

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,332 Total Patients Enrolled

John Wrangle, MDPrincipal InvestigatorMedical University of South Carolina

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the first time that ALT-803 has been studied?

"There are currently 770 active studies and 86 Phase 3 clinical trials researching ALT-803. While some of these trials are based in Ciudad de mexico and Maryland, there are 40984 research locations for ALT-803."

Answered by AI

What are the conditions that ALT-803 is used to treat?

"ALT-803 is most often applied in the treatment of malignant neoplasms. However, it has also been used to effectively treat unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Can people with various medical conditions participate in this clinical trial?

"Unfortunately, this particular trial is not currently looking for new patients. The study was last updated on 8/9/2022, though it is still possible to view the original posting from 1/8/2016. There are 1989 other trials for carcinoma, non-small-cell lung and 770 for ALT-803 that are currently looking for new participants."

Answered by AI

How many people are allowed to be in this trial at any one time?

"This study is not actively recruiting at this time, according to the most recent update on clinicaltrials.gov. The trial was originally posted on 1/8/2016 and was last edited on 8/9/2022. There are presently 1989 trials actively recruiting participants with carcinoma, non-small-cell lung and 770 trials for ALT-803 actively admitting patients."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

ALT-803, an IL-15 Superagonist, in Combination with Nivolumab in Patients with Metastatic Non-small Cell Lung Cancer: A Non-randomised, Open-label, Phase 1b Trial

Wrangle, John M, Vamsidhar Velcheti, Manish R Patel, Elizabeth Garrett-Mayer, Elizabeth G Hill, James G Ravenel, Jeffrey S Miller, et al.. 2018. “ALT-803, an IL-15 Superagonist, in Combination with Nivolumab in Patients with Metastatic Non-small Cell Lung Cancer: A Non-randomised, Open-label, Phase 1b Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30148-7.

clinicaltrials.govStudy

ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer

2016. "ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02523469.