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Monoclonal Antibodies

Safety Run-In Part: M7824 + Gemcitabine + Cisplatin for Bile Duct Cancer

Phase 2 & 3

Waitlist Available

Research Sponsored by EMD Serono Research & Development Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to day 21 of cycle 1 (each cycle is of 21 days)

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it can help people with biliary tract cancer live longer than the current standard of care.

Eligible Conditions

Bile Duct Cancer
Biliary Tract Cancer
Gallbladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to day 21 of cycle 1 (each cycle is of 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to day 21 of cycle 1 (each cycle is of 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 21 of cycle 1 (each cycle is of 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Double-blind Part: Overall Survival

Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)

Secondary outcome measures

Double-blind Part: Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator

Blindness

Therapeutic procedure

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Safety Run-In Part: M7824 + Gemcitabine + CisplatinExperimental Treatment3 Interventions

Group II: Double-blinded Part: M7824 + Gemcitabine + CisplatinExperimental Treatment3 Interventions

Group III: Double-blinded Part: Placebo + Gemcitabine + CisplatinPlacebo Group3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

M7824

2020

Completed Phase 2

~350

Cisplatin

2013

Completed Phase 3

~1940

Gemcitabine

2017

Completed Phase 3

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,551 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,347 Total Patients Enrolled

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

288 Previous Clinical Trials

68,666 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common conditions that Bintrafusp alfa helps to treat?

"Bintrafusp alfa can be an effective treatment against neoplasm metastasis, urinary bladder, and advanced testicular cancer."

Answered by AI

What other data is there on Bintrafusp alfa?

"There are currently 1028 ongoing clinical trials for Bintrafusp alfa, with 347 of them in Phase 3. However, these trials are not exclusive to Shanghai, as there are 52424 locations around the world running trials for Bintrafusp alfa."

Answered by AI

Are medical professionals still looking for participants for this clinical trial?

"Unfortunately, this particular trial is not recruiting patients at this moment. The listing was created on September 20th, 2019 but was updated on May 16th, 2022. For other opportunities, there are 300 trials related to cholangiocarcinoma and 1028 studies centred around Bintrafusp alfa that are looking for volunteers."

Answered by AI

In how many different hospitals is this research project being conducted today?

"Eligible patients are being recruited from Renovatio Clinical - CENTRAL SITE in The Woodlands, Massachusetts, University of Massachusetts Memorial Medical Center - Pediatrics in Worcester, Illinois, Northwestern Center for Clinical Research in Chicago, and 18 other locations."

Answered by AI

How many individuals are being given the opportunity to participate in this research project?

"This specific trial has concluded its search for participants. However, there are presently 300 studies actively recruiting participants with cholangiocarcinoma and 1028 studies for Bintrafusp alfa actively searching for patients."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Phase I Study of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting Tgf-β and PD-L1, in Patients with Pretreated Biliary Tract Cancer

Yoo, Changhoon, Do-Youn Oh, Hye Jin Choi, Masatoshi Kudo, Makoto Ueno, Shunsuke Kondo, Li-Tzong Chen, et al.. 2020. “Phase I Study of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting Tgf-β and PD-L1, in Patients with Pretreated Biliary Tract Cancer”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2020-000564.

Journal for ImmunoTherapy of CancerJournal

Phase I Study of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting Tgf-β and PD-L1, in Patients with Pretreated Biliary Tract Cancer

clinicaltrials.govStudy

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

2019. "Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04066491.