Study of Tremelimumab in Patients With Advanced Solid Tumors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-02

Study Completion Date

2023-03-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Urothelial Bladder Cancer Triple-negative Breast Cancer Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treme mono to be sequenced to MEDI4736 mono or combination

tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)

Group Type EXPERIMENTAL

Tremelimumab monotherapy

Intervention Type BIOLOGICAL

IV infusion

MEDI4736 monotherapy

Intervention Type BIOLOGICAL

IV infusion

MEDI4736 + tremelimumab combination therapy

Intervention Type BIOLOGICAL

IV infusion

Interventions

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Tremelimumab monotherapy

IV infusion

Intervention Type BIOLOGICAL

MEDI4736 monotherapy

IV infusion

Intervention Type BIOLOGICAL

MEDI4736 + tremelimumab combination therapy

IV infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

150 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No