Drug Screening Using IMD in Bladder Cancer

Summary

This research study involves implanting up to 4 microdevices, each small enough to fit inside the tip of a needle, into a tumor. These devices will release microdoses (many thousands of times less than a treatment dose) of different cancer drugs into the tumor. After approximately 72 hours, the devices and small regions of surrounding tissue will be removed and studied. There will be a follow-up visit within 42 days of device removal to assess for potential safety issues or side effects.

Conditions

• Muscle Invasive Bladder Urothelial Carcinoma

Interventions

DRUG

Gemcitabine/Carboplatin/Nivolumab

(Gemcitabine/Carboplatin/Nivolumab) will be placed in reservoir 18 of the implantable microdevice.

DRUG

Enfortumab

Enfortumab will be placed in reservoir 19 of the implantable microdevice.

DRUG

Sacituzumab

Sacitzumab will be placed in reservoir 20 of the implantable microdevice.

DRUG

Gemcitabine/Cisplatin II

Gemcitabine/Cisplatin will be placed in reservoir 8 of the implantable microdevice.

DRUG

Cisplatin

Cisplatin will be placed in reservoir 9 of the implantable microdevice.

DRUG

Nivolumab

Nivolumab will be placed in reservoir 10 of the implantable microdevice.

DRUG

Pembrolizumab

Pembrolizumab will be placed in reservoir 11 of the implantable microdevice.

DRUG

Gemcitabine/Carboplatin

Gemcitabine/Carboplatin will be placed in reservoir 12 of the implantable microdevice.

DRUG

Methotrexate/Vinblastine/Doxorubicin/Cisplatin

(Methotrexate/Vinblastine/Doxorubicin/Cisplatin) will be placed in reservoir 13 of the implantable microdevice.

DRUG

Gemcitabine/Cisplatin/Nivolumab

(Gemcitabine/Cisplatin/Nivolumab) will be placed in reservoir 14 of the implantable microdevice.

DRUG

Erdafitinib

Erdafitinib will be placed in reservoir 15 of the implantable microdevice.

DRUG

Paclitaxel/Docetaxel/Ifosfamide

(Paclitaxel/Docetaxel/Ifosfamide) will be placed in reservoir 16 of the implantable microdevice.

DRUG

Gemcitabine

Gemcitabine will be placed in reservoir 17 of the implantable microdevice.

DEVICE

Implantable Micro-Device

The implantable microdevice will release microdoses of specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against bladder cancer.

DRUG

Methotrexate

Methotrexate will be placed in reservoir 1 of the implantable microdevice.

DRUG

Carboplatin

Carboplatin will be placed in reservoir 2 of the implantable microdevice.

DRUG

Avelumab

Avelumab will be placed in reservoir 3 of the implantable microdevice.

DRUG

Paclitaxel

Paclitaxel will be placed in reservoir 4 of the implantable microdevice.

DRUG

Vinblastine

Vinblastine will be placed in reservoir 5 of the implantable microdevice.

DRUG

Gemcitabine/Cisplatin I

Gemcitabine/Cisplatin will be placed in reservoir 6 of the implantable microdevice.

DRUG

Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab

(Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab) will be placed in reservoir 7 of the implantable microdevice.

Sponsors & Collaborators

• Brigham and Women's Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-14

Primary Completion

2028-07-01

Completion

2028-08-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations