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

Phase 2

Completed

• Conditions: FIGO Stage III and IV Ovarian Cancer; FIGO Stage III and IV Fallopian Tube Cancer; FIGO Stage III Primary Peritoneal Cancer
• Interventions: Biological: ALT-803 Intraperitoneal; Biological: ALT-803 Subcutaneous

• Registration Number: NCT03054909
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

In this study all patients receive four 8 week cycles of ALT-803 consisting of 4 weekly doses followed by a 4 week rest (no treatment). As it is not known how intraperitoneal (IP) administration (a route of drug administration frequently used for gynecologic cancers) of ALT-803 compares to subcutaneous (SQ) administration, both routes of administration will be tested. The primary objective of this trial is to select one method of delivery for further testing.

Study Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Start: 2017-09-19
• Primary Completion: 2022-02-16
• Study Completion: 2022-02-16
• Results First Submitted: 2023-03-15
• Results First Submitted QC: 2023-04-11
• Results First Posted: 2023-05-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: ALT-803 intraperitoneal and subcutaneous	ALT-803 Intraperitoneal	-
Arm 1: ALT-803 subcutaneous only	ALT-803 Subcutaneous	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	6 months	Incidence of Progression Free Survival after first treatment of ALT-803.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 year	Overall Survival after first treatment of ALT-803.
ALT-803 Associated Toxicities	1 year	Incidence of ALT-803 associated toxicities after first treatment of ALT-803.
Progression Free Survival	2 years	Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate.
Incidence of Recorded Toxicity Grade 3 or Greater	1 year	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.

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States