Study of Tremelimumab in Patients With Advanced Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2019 |
Start Date: | November 2, 2015 |
End Date: | December 31, 2020 |
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with
Advanced Solid Tumors
Advanced Solid Tumors
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.
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.
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
We found this trial at
4
sites
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