MedTrace Logo

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

NCT02431559 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-10-10

Study results available
· View outcomes & findings →

Summary

This is an ongoing Phase 1/2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with recurrent, platinum-resistant ovarian cancer who are scheduled to receive pegylated liposomal doxorubicin (PLD).The primary objective of Phase 1 is to determine the maximum tolerated dose (MTD) and safety profile, with a secondary objective to evaluate the clinical efficacy as measured by progression-free survival (PFS) rate at 6 months (PFS-6). The primary objective of Phase 2 is the evaluation of clinical efficacy as measured by PFS-6. For both phases, secondary objectives include evaluation of clinical efficacy as measured by overall response rate, PFS, and overall survival (OS), safety and tolerability, and immunological responses.

Conditions

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.

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • George Coukos, MD, PhD · University of Lausanne Hospitals

  • Bradley J Monk, MD · Arizona Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-02
Primary Completion
2018-12-11
Completion
2021-06-10
FDA Drug
Yes

Countries

  • United States
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431559 on ClinicalTrials.gov