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

NCT03054909 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2016LS034
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

FIGO Stage III and IV Ovarian Cancer; FIGO Stage III and IV Fallopian Tube Cancer; FIGO Stage III Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

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

  6 months

Secondary Outcomes (6)

• Progression Free Survival

  1 year

• Overall Survival

  1 year

• ALT-803 Associated Toxicities

  1 year

• Incidence of Recorded Toxicity Grade 3 or Greater

  1 year

• Progression Free Survival

  2 years

Study Arms (2)

Arm 1: ALT-803 subcutaneous only

EXPERIMENTAL

Biological: ALT-803 Subcutaneous

Arm 2: ALT-803 intraperitoneal and subcutaneous

EXPERIMENTAL

Biological: ALT-803 Intraperitoneal

Interventions

ALT-803 Subcutaneous BIOLOGICAL

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 1: ALT-803 subcutaneous only

ALT-803 Intraperitoneal BIOLOGICAL

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).

Arm 2: ALT-803 intraperitoneal and subcutaneous

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to begin study therapy within 3 months of final dose of first line chemotherapy
• Functioning intraperitoneal catheter
• ≥ 18 years of age
• GOG performance status ≤ 2 (Appendix II)
• Adequate organ function within 14 days of enrollment defined as:
• Hematology: hemoglobin ≥ 8 g/dl, absolute neutrophil count (ANC) ≥ 1500/ul, platelets ≥ 50 x 109/L
• Creatinine: ≤ 2.0 mg/dL
• Hepatic: SGOT and SGPT ≤ 3 x upper limit of institutional normal (ULN)
• Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to and while receiving ALT-803
• Voluntary written consent prior to the performance of any research related procedures

You may not qualify if:

• Received any investigational agent within the 14 days before the start of ALT-803
• Class II or greater New York Heart Association Functional Classification criteria (Appendix II) or serious cardiac arrhythmias likely to increase the risk of cardiac complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
• Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
• Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
• Active autoimmune disease requiring systemic immunosuppressive therapy
• History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
• Uncontrolled hypertension: defined as ≥2 readings over 160 mmHg systolic or 110 mmHg diastolic within month prior to enrollment despite optimal anti-hypertensive medication. Patients with high readings which improve to ≤160/110 after adjustment of medications will be eligible.
• History of pulmonary disease or abnormal pulmonary function studies
• History of narcolepsy or any neurological condition which may impair consciousness

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Results Point of Contact

• Title: Dr. Melissa Geller
• Organization: University of Minnesota, Masonic Cancer Center

gelle005@umn.edu

+1 612-626-3111

Study Officials

• Melissa Geller, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 16, 2017
• Study Start: September 19, 2017
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: October 13, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-10

Locations

US (1)