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ENROLLING BY INVITATION
NCT06204614
EARLY_PHASE1

Drug Screening Using IMD in Bladder Cancer

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Official title: Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-06-14

Completion Date

2028-08-01

Last Updated

2026-05-18

Healthy Volunteers

Yes

Interventions

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.

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.

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States