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Last Updated: 06/30/17

Information below provided by the Pharmaceutical Company.

Tremelimumab (CP-675,206)

Agent Description

Human immunoglobulin IgG2 monoclonal antibody specific for human cytotoxic T lymphocyte-associated antigen 4 (CTLA-4; CD152), a cell surface receptor that is expressed primarily on activated T cells.

Mechanism of Action

Anti-CTLA4 monoclonal antibody that blocks the inhibitory signal resulting from CTLA-4 binding to CD80/86, leading to prolongation and enhancement of T-cell activation and expansion.

Classification

Anti-CTLA4 monoclonal antibody; immunotherapeutic

Molecular Target

CTLA4

Monograph

CTLA-4 is expressed exclusively on the surface of T cells. CTLA-4 serves to inhibit T-cell activation through delivery of inhibitory signals and through ligand competition with the co-stimulatory receptor, CD28. Inhibition of CTLA-4 can shift the balance of signaling in the immune system in favor of greater T-cell activation, engendering a greater immune response and potentially resulting in the rejection of tumor by the host's immune system.

Tremelimumab is an investigational anti-CTLA-4 monoclonal antibody being clinically evaluated in combination therapy for the potential treatment of cancer.

Studies of Interest

Areas of interest:

Priority will be given to proposals that advance understanding of core development programs in NSCLC, Bladder and HNSCC. Only Tremelimumab + Durvalumab combination proposals will be considered.

The following should be used as general guidance:

  • Translationally focused proposals that are designed to gain insight into mechanisms of intrinsic or acquired resistance to tremelimumab + durvalumab combination therapy.
  • Non-small Cell Lung Cancer:
    • Tremelimumab + durvalumab in patients excluded from the registration program (un-resectable Stage IIIA/IIIB and Stage IV)
    • Tremelimumab + durvalumab combinations with chemotherapy, radiotherapy or other agents (immunotherapy/targeted therapies)
    • Patient reported outcomes and patient experience of patients receiving tremelimumab + durvalumab
  • Urothelial Cancer:
    • Tremelimumab + durvalumab combined with SoC chemotherapy in front-line metastatic urothelial cancer
    • Tremelimumab + durvalumab combined with novel agents or radiotherapy in front-line or relapsed bladder cancer
    • Optimal utilization of tremelimumab + durvalumab in non-muscle invasive bladder cancer
    • Tremelimumab + durvalumab combined with SoC chemotherapy, novel agents, or radiotherapy in patients with stage II-IV non-metastatic disease
    • Patient reported outcomes and experience of patients receiving tremelimumab + durvalumab in bladder cancer
  • Head & Neck Cancer:
    • Tremelimumab + durvalumab in HNSCC patients excluded from the registration programs
    • Tremelimumab + durvalumab in locally advanced HNSCC sub-populations
    • Tremelimumab + durvalumab combined with targeted agents (e.g. cetuximab, AZ targeted small molecules etc.), radiotherapy and/or chemotherapy
    • Patient reported outcomes and experience of patients receiving tremelimumab + durvalumab in HNSCC

Areas NOT of interest:

  • Studies that overlap or compete with AstraZeneca development program or where there is compromised or excessive safety risk will not be accepted
  • Single agent tremelimumab or combination proposals other than with durvalumab

Information collaborator would like included in investigator proposals

N/A