Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer

Titre officiel

A Pilot Study of Atezolizumab (MPDL3280A) Following Adoptive Cell Transfer in Active Hematologic or Solid Tumour Malignancies

Sommaire:

Cet essai de phase I vise à étudier les effets secondaires de l’atézolizumab chez les patients atteints d’un cancer après un transfert adoptif de cellules. Les anticorps monoclonaux comme l’atézolizumab peuvent nuire à la capacité des cellules tumorales de se développer et de se propager.

Description de l'essai

Primary Outcome:

• Incidence of adverse events

Secondary Outcome:

• Expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumour microenvironment
• Phenotype and function of engrafted T cells following atezolizumab administration
• Anti-tumour activity
• The response rate
• Survival outcomes
• Progression free survival
• Biomarker analysis

PRIMARY OBJECTIVE:

• To evaluate the safety of atezolizumab (MPDL3280A) administration in patients who have received adoptive cell transfer (ACT) prior to enrollment.

SECONDARY OBJECTIVES:

• To evaluate the expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumour microenvironment.
• To evaluate the phenotype and function of engrafted T cells following atezolizumab administration.
• To observe and record anti-tumour activity.
• To evaluate the response rate using immune related Response Criteria (irRC) and Response Evaluation Criteria in Solid Tumours (RECIST) version (v)1.1, or other tumour-specific criteria.
• To evaluate survival outcomes and progression free survival using irRC and RECIST v1.1, or other tumour-specific criteria.

OUTLINE:
Patients receive atezolizumab intravenously (IV) over 30- 60 minutes on day 1. Cycles repeat every 21 days for a total of 17 doses over up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and then every 3 months thereafter.

Voir cet essai sur ClinicalTrials.gov