CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
ALT-803 Subcutaneous +1 morebiological
Likely dose
ALT-803 Subcutaneous 10 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03054909
NCT03054909Phase 2Completed
CompareCT.gov

QUILT-2.021: Randomized Study of Single Course of Intraperitoneal (IP) ALT-803 Followed by Subcutaneous (SQ) Maintenance ALT-803 Versus Subcutaneous (SQ) Maintenance ALT-803 Only After 1st Line Chemotherapy for Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Masonic Cancer Center, University of Minnesota·interventional·Posted Feb 16, 2017·Updated Oct 13, 2023

In Brief

A Phase 2 clinical trial evaluating ALT-803 Subcutaneous and ALT-803 Intraperitoneal for FIGO Stage III and IV Ovarian Cancer and 2 related conditions. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFIGO Stage III and IV Ovarian Cancer, FIGO Stage III and IV Fallopian Tube Cancer, FIGO Stage III Primary Peritoneal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 16, 2017
Enrollment StartSep 19, 2017
Primary CompletionFeb 16, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.4 years ago

Interventions

ALT-803 Subcutaneousbiological

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)

ALT-803 Intraperitonealbiological

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).