Study of Tremelimumab in Patients With Advanced Solid Tumors

Completed · Phase 2

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

In brief

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

Key facts

Study ID

NCT02527434

Run by

AstraZeneca

People needed

64

Starts

2015-11-02

Expected to finish

2023-03-28

Last updated by the study team

2023-11-15

Who can join

Age: 18 and older, up to 150. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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