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Tremelimumab monotherapy

Phase 2

Urothelial Bladder Cancer | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Nov 15, 2023

Target and mechanism

Molecular targetCTLA4
Target classInhibitor
ModalityMonoclonal antibody

Also known as Tremelimumab, Tremelimumab (Regimen 1)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Tremelimumab monotherapy · 1 trial · 3 indications

Phase 2 1
NCT02527434Study of Tremelimumab in Patients With Advanced Solid TumorsUrothelial Bladder Cancer
COMPLETED64 Analytics
PHASE2COMPLETED
Study of Tremelimumab in Patients With Advanced Solid Tumors
Urothelial Bladder CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
From baseline to 12 months in the tremelimumab monotherapy phase

Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.

Secondary Endpoints

Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase
From baseline to 12 months in the tremelimumab monotherapy phase
Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase
From baseline to 12 months in the tremelimumab monotherapy phase
Median PFS During Tremelimumab Monotherapy Phase
From baseline to 12 months in the tremelimumab monotherapy phase
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
Tremelimumab monotherapyBIOLOGICALIV infusion
MEDI4736 monotherapyBIOLOGICALIV infusion
MEDI4736 + tremelimumab combination therapyBIOLOGICALIV infusion
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Eligibility Criteria

Age Range18 Years to 150 Years
SexALL
Healthy VolunteersNo
Study Sites14

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 previou...

Countries:United StatesBelgiumNetherlandsPolandSouth Korea
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Frequently asked questions about Tremelimumab monotherapy

What is Tremelimumab used for?

Tremelimumab is an investigational antibody being studied in oncology. It is being evaluated for combined hepatocellular and cholangiocarcinoma, urothelial bladder cancer, non small cell lung cancer, urothelial carcinoma, colorectal cancer, and advanced solid malignancies. It is typically studied in combination with durvalumab.

What does Tremelimumab target?

Tremelimumab is a monoclonal antibody that targets CTLA-4, a protein on T cells that downregulates immune responses. By blocking CTLA-4, tremelimumab is designed to enhance the immune system's ability to attack cancer cells. It is being developed by AstraZeneca.

Who makes Tremelimumab?

Tremelimumab is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials of tremelimumab across multiple cancer types, often in combination with durvalumab.

What phase is Tremelimumab in?

Tremelimumab is in Phase 2 clinical development. It is not yet approved by the FDA and remains investigational. Several Phase 2 trials are ongoing or completed, including studies in colorectal cancer and urothelial carcinoma.

What clinical trials is Tremelimumab in?

Tremelimumab is being studied in several trials. NCT02870920 is a completed Phase 2 trial in colorectal cancer. NCT03317158 is an active Phase 1 trial in urothelial carcinoma. NCT03557918 is a completed Phase 2 trial in urothelial cancer. NCT06855225 is a Phase 2 trial in combined hepatocellular-cholangiocarcinoma.

Is Tremelimumab the same as Tremelimumab (Regimen 1)?

Yes, Tremelimumab is also known as Tremelimumab (Regimen 1). This alternative name is used in clinical trial contexts to distinguish a specific dosing schedule or combination approach. Both names refer to the same investigational drug.