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Study of Tremelimumab in Patients With Advanced Solid Tumors
Study of Tremelimumab in Patients With Advanced Solid Tumors

NCT02527434

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Urothelial Bladder Cancer, Triple-negative Breast Cancer, Pancreatic Ductal Adenocarcinoma

Interventions: Tremelimumab monotherapy, MEDI4736 monotherapy, MEDI4736 + tremelimumab combination therapy

Countries: United States, Belgium, Netherlands, Poland, South Korea

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

Eligibility overview

Sex: ALL

Age: 18 Years to 150 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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.

Exclusion criteria:

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 (14)
  • San Francisco, California, United States
  • Memphis, Tennessee, United States
  • Houston, Texas, United States
  • Brussels, Belgium
  • Charleroi, Belgium
  • Wilrijk, Belgium
  • Groningen, Netherlands
  • Utrecht, Netherlands
  • Gdansk, Poland
  • Lodz, Poland
  • Daejeon, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea