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GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

NCT ID: NCT05998447

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-11-26

Brief Summary

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This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. The safety run-in phase will be conducted before the main study phase

Detailed Description

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Conditions

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Biliary Tract Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX

Drug: GEN-001

Drug: pembrolizumab

Drug: mFOLFOX

Group Type EXPERIMENTAL

GEN-001

Intervention Type DRUG

The capsules taken by mouth. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)

Pembrolizumab

Intervention Type DRUG

200 mg given by intravenous (IV) infusion once every 3 weeks

mFOLFOX

Intervention Type DRUG

mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3

Interventions

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GEN-001

The capsules taken by mouth. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)

Intervention Type DRUG

Pembrolizumab

200 mg given by intravenous (IV) infusion once every 3 weeks

Intervention Type DRUG

mFOLFOX

mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA®

Eligibility Criteria

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Inclusion Criteria

* The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
* Be ≥19 years of age on day of signing informed consent.
* Patient with histologically or cytologically confirmed diagnosis of unresectable, recurrent, or metastatic advanced biliary tract adenocarcinoma of the gallbladder or biliary tree (either intrahepatic or extrahepatic cholangiocarcinoma)

Exclusion Criteria

* A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (Cohort 1 only), and was discontinued from the previous IO therapy due to a Grade 3 or higher immune-related AE (irAE) (Cohort 2 and Cohort 3).
* Is currently participating and receiving study treatments or has participated in a study of an investigational agent and received the study therapy or has used an investigational device within 4 weeks prior to the first dose of study treatment.
* Has had an allogeneic tissue/solid organ transplan
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Genome & Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Severance Hospital

Seoul, Seoul, South Korea

Site Status

Asan Medical Center

Seoul, Seoul, South Korea

Site Status

Samsung Medical Center.

Seoul, Seoul, South Korea

Site Status

Korea University Guro Hospital

Seoul, Seoul, South Korea

Site Status

Ajou University Medical Center

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KEYNOTE-D86

Identifier Type: OTHER

Identifier Source: secondary_id

MK-3475-D86

Identifier Type: OTHER

Identifier Source: secondary_id

[GNC] GEN001-202

Identifier Type: -

Identifier Source: org_study_id