Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

December 2, 2015

Primary Completion Date

December 11, 2018

Study Completion Date

June 10, 2021

Conditions
Ovarian Cancer
Interventions
DRUG

Durvalumab

Durvalumab is administered as an IV infusion over 60 ± 5 minutes.

DRUG

Pegylated Liposomal Doxorubicin

PLD was administered as an IV infusion in accordance with local prescribing information.

DRUG

Motolimod

Motolimod was administered as an SC injection. Within 30 minutes prior to each dose of motolimod, subjects were administered 650-1000 mg acetaminophen by mouth to help mitigate potential adverse events (AEs) commonly associated with the administration of motolimod (e.g., fever, myalgia). On days with concurrent motolimod and durvalumab dosing, motolimod administration occurred 30-60 minutes after the end of the durvalumab infusion. After completion of Phase 1, a protocol amendment was implemented to remove motolimod dosing from the study.

Trial Locations (5)

1011

Research Facility, Lausanne

10065

Research Facility, New York

43026

Research Facility, Hilliard

85016

Research Facitlity, Phoenix

02905

Research Facility, Providence

All Listed Sponsors
collaborator

MedImmune LLC

INDUSTRY

collaborator

Celgene

INDUSTRY

collaborator

Cancer Research Institute, New York City

OTHER

lead

Ludwig Institute for Cancer Research

OTHER