A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)

Conditions

• Muscle Invasive Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  Durvalumab is a monoclonal antibody (an antibody is a protein produced by the body's immune system) that works by blocking the Programmed Cell Death Ligand 1 (PD-L1), a protein on cancer cells that stops the body's immune system from killing cancer cells.
• Oleclumab — DRUG
  Oleclumab is a monoclonal antibody that works by reducing the amount of adenosine, a small molecule called a metabolite that binds to adenosine receptors on immune cells to regulate the immune system and suppress the immune response. Reducing the amount of immunosuppressive adenosine can increase the body's immune response to kill cancer cells.

Study Details

This research study is studying a new anti-cancer drug durvalumab (MEDI4736) with or without another new anti-cancer drug Oleclumab (MEDI9447) before surgery for bladder cancer. The drugs involved in this study are: * Durvalumab (MEDI4736) * Oleclumab (MEDI9447)

Key Dates

Start date

Feb 20, 2019

Status verified

Sep 2022

Primary completion

Feb 4, 2021

Completion

Aug 2, 2021

Study Design

Enrollment

12 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab
  -Durvalumab will be administered intravenously every 2 weeks, with 14 consecutive days defined as a treatment cycle
• Experimental: Durvalumab + Oleclumab
  * Durvalumab will be administered intravenously every 2 weeks, with 14 consecutive days defined as a treatment cycle * Oleclumab will be administered intravenously every 2 weeks, with 14 consecutive days defined as a treatment cycle

Primary Outcome Measure

Number of Participants Receiving at least One Dose of Study Therapy Followed by Surgery without Dose-Limiting Toxicity (DLT) up to Twelve Weeks Post-Radical Cystectomy (RC) [ Time Frame: 2 years ]

Locations (2)

Find similar trials in Boston, MA

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