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

Sponsor
Yale University
Study ID
NCT04223648
Phase
EARLY_PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tremelimumab/durvalumab, ipilimumab/nivolumab and nivolumab monotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 15, 2020
Status verified
Nov 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment
    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.

Primary Outcome Measure

PD1+ cell pharmacodynamic response in blood to tremelimumab/durvalumab treatment [ Time Frame: up to 10 days post-enrollment. ]

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