Breast Cancer Clinical Trial

Study of Tremelimumab in Patients With Advanced Solid Tumors

Summary

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

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Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT02527434

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 14 Locations for this study

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Research Site
San Francisco California, 94158, United States
Research Site
Memphis Tennessee, 38120, United States
Research Site
Houston Texas, 77030, United States
Research Site
Brussels , 1090, Belgium
Research Site
Charleroi , 6000, Belgium
Research Site
Wilrijk , 2610, Belgium
Research Site
Daejeon , 35015, Korea, Republic of
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 135-7, Korea, Republic of
Research Site
Groningen , 9713 , Netherlands
Research Site
Utrecht , 3584 , Netherlands
Research Site
Gdańsk , 80-21, Poland
Research Site
Łódź , 93-51, Poland

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

64

Study ID:

NCT02527434

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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