Skip to main content
Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Official Title

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors

Details

This is an open-label, multi-center study to determine the efficacy and safety of tremelimumab in the treatment of different cohorts of patients with selected advanced solid tumors. If eligible and at the discretion of the Investigator, after confirmed disease progression on tremelimumab monotherapy or during follow-up, patients will have the option of being sequenced to MEDI4736 (MedImmune 4736) monotherapy or MEDI4736 + tremelimumab combination therapy, for up to 12 months or until disease progression, whichever comes sooner.

Keywords

UBC (Urothelial Bladder Cancer)/ TNBC (Triple-negative Breast Cancer)/ PDAC (Pancreatic Ductal Adenocarcinoma) Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR Antibodies, Monoclonal Tremelimumab

Eligibility

You can join if…

Open to people ages 18 years and up

  1. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.

You CAN'T join if...

  1. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2.History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula(QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient

Locations

  • Research Site
    San Francisco, California, USA
  • Research Site
    Memphis, Tennessee, USA
  • Research Site
    Houston, Texas, USA
  • Research Site
    Brussels (Jette), Belgium
  • Research Site
    Charleroi, Belgium
  • Research Site
    Wilrijk, Belgium
  • Research Site
    Daejeon, Korea, Republic of
  • Research Site
    Seoul, Korea, Republic of
  • Research Site
    Groningen, Netherlands
  • Research Site
    Utrecht, Netherlands
  • Research Site
    Gdańsk, Poland
  • Research Site
    Łódź, Poland

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT02527434
Phase
Phase 2
Lead Scientist
Terence Friedlander
Study Type
Interventional
Last Updated
January 2017