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Programmed Cell Death 1 + Selected Cell Therapy With Durvalumab (MEDI4736) and Tremelimumab in Metastatic Melanoma

NCT04223648 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2021-11-22

No results posted yet for this study

Summary

The primary objective of this pilot study is to assess the feasibility of mobilizing PD-1+ T cells to the peripheral blood after a single treatment with tremelimumab/durvalumab in patients with treatment naïve metastatic melanoma.

Conditions

  • Malignant Melanoma

Interventions

DRUG

tremelimumab/durvalumab, ipilimumab/nivolumab and nivolumab monotherapy

Subjects will receive 1 cycle of tremelimumab/durvalumab * Subjects will undergo resection to obtain tumor for generation of autologous tumor infiltrating lymphocytes (TIL) cultures and blood draw to obtain peripheral blood mononuclear cell (PBMC)s * TIL and PBMC will undergo immunoselection based on binding to an anti-programmed cell death 1 (PD-1) antibody and then will be expanded ex vivo. Subjects will receive 3 cycles of ipilimumab/nivolumab • Subjects will undergo staging with computer tomography (CT) chest/abdomen/pelvis and brain magnetic resonance imaging (MRI) or CT scan. subjects with stable disease will continue with nivolumab monotherapy; Subjects with progressive disease will proceed to cell therapy.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Michael Hurwitz, MD, PhD · Yale University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2022-02-28
Completion
2025-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223648 on ClinicalTrials.gov