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Immunotherapy

M7824 for Bile Duct Cancer

Phase 2

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 at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421 and day 505

Awards & highlights

Study Summary

This trial is studying a new drug for biliary tract cancer that has progressed despite treatment with other chemotherapy drugs.

Eligible Conditions

Bile Duct Cancer
Biliary Tract Cancer
Gallbladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421 and day 505

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421 and day 505

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 15, day 29, day 43, day 85, day 127, day 169, day 253, day 337, day 421 and day 505 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

Secondary outcome measures

Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status

+15 more

Side effects data

From 2023 Phase 1 & 2 trial • 21 Patients • NCT04247282

43%

Oral hemorrhage

36%

Constipation

36%

Fatigue

36%

Lymphocyte count decreased

36%

Epistaxis

29%

Dysphagia

29%

Weight loss

21%

Hyperglycemia

21%

Pruritus

21%

Wound infection

21%

Anemia

14%

Hyperthyroidism

14%

Lipase increased

14%

Rash acneiform

14%

White blood cell decreased

14%

Creatinine increased

14%

Gait disturbance

14%

Rash maculo-papular

14%

Tumor hemorrhage

14%

Alanine aminotransferase increased

14%

Oral pain

Palpitations

Aspartate aminotransferase increased

Blood bilirubin increased

Cough

Flu like symptoms

Hyponatremia

Hypoxia

Intraoperative head and neck injury

Vaccination site lymphadenopathy

Gastrointestinal disorders - Other, Sialadenitis

Hematuria

Respiratory failure

Atrial fibrillation

CPK increased

Dermatitis radiation

GGT increased

Hypermagnesemia

Hypophosphatemia

Nausea

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Peripheral sensory neuropathy

Aphonia

Dehydration

Edema limbs

Mucositis oral

Tumor pain

Lung infection

Sinus tachycardia

Vasculitis

Alkaline phosphatase increased

Dysarthria

Dysesthesia

Dysgeusia

Hypothyroidism

Pain

Skin ulceration

Stroke

100%

80%

60%

40%

20%

Study treatment Arm

Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15)

Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1)

Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1)

Trial Design

1Treatment groups

Experimental Treatment

Group I: M7824Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

M7824

2020

Completed Phase 2

~350

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

30,701 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,497 Total Patients Enrolled

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

288 Previous Clinical Trials

68,816 Total Patients Enrolled

Frequently Asked Questions

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

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

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

2019. "M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03833661.

~26 spots leftby Apr 2025

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