NCT04727541

Brief Summary

The NEOBIL study aims to investigate the feasibility, safety and efficacy of neoadjuvant Bintrafusp alfa in patients with resectable biliary tract cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

January 25, 2021

Last Update Submit

May 17, 2022

Conditions

Biliary Tract CancerCholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Major Pathologic Response (MPR) measured in the surgically resected tumor

    Response to neoadjuvant treatment will be determined according to the Becker score. MPR is defined by a Becker grade of 1 (1a or 1b), namely at least \< 10% of viable tumor.

    24 months

Secondary Outcomes (4)

  • Tumor Response

    24 months

  • Rate of Resectability

    24 months

  • Adverse events according to CTCAE V5

    24 months

  • Adverse Events of Special Interest

    24 months

Study Arms (1)

Neoadjuvant therapy with Bintrafusp alfa

EXPERIMENTAL

1200 mg of Bintrafusp alfa will be administered by intravenous infusion every 2 weeks for a total of 2 dosages (Q2W). Subsequently, the surgery will be performed.

Drug: Bintrafusp alfa

Interventions

Bintrafusp alfaDRUG

Neoadjuvant therapy with bintrafusp alfa

Also known as: MSB0011359C, M7824
Neoadjuvant therapy with Bintrafusp alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent granted prior to initiation of any study-specific screening procedures
  • Biliary tract cancer, confirmed by histopathology, cytopathology is not sufficient
  • Resectable disease limited to the liver assessed by an interdisciplinary tumor board involving a hepatobiliary surgeon; no prior systemic therapy
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Age ≥ 18 years
  • Performance status ECOG 0-1
  • Normal organ and bone marrow function defined as:
  • Hematopoetic: absolute neutrophil count ≥1,500/mm3, platelet count ≥ 100,000/mm3,
  • Hemoglobin ≥9 g/dL
  • Normal international normalized ratio (INR), PT ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
  • Hepatic: AST ≤5 x ULN, ALT ≤ 5 x ULN, and bilirubin ≤ 3.0 x ULN.
  • Renal: Creatinine level ≤1.5 x ULN or estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
  • Special medical conditions and comorbidities:
  • Maximum Child Pugh stage A in patients with cirrhosis
  • HIV: stable on ART for at least 4 weeks, no documented evidence of multi-drug resistance, viral load of \< 400 copies/mL and CD4+ T-cells ≥ 350 cells/µL.
  • +4 more criteria

You may not qualify if:

  • Metastatic disease
  • Prior surgery, systemic therapy, radiation therapy, chemoradiation, transarterial chemoembolisation (TACE), Radiofrequency ablation (RFA) or selective intraarterial Radiotherapy (SIRT) for treatment of CCA. NOTE: Laparoscopy for diagnostic procedures is allowed.
  • Drug or alcohol addiction, medical or psychological condition that may interfere with the patient´s participation in the study
  • Participation in another clinical trial with any investigational study drug (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to enrollment
  • Pregnancy or breast feeding women
  • Regulatory and ethical criteria:
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities \[§ 40 Abs. 1 S. 3 Nr. 4 AMG\].
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\].
  • IMMUNOSUPRESSANTS: "Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)."
  • AUTOIMMUNE DISEASE: "Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible."
  • PREVIOUS MALIGNANT DISEASE: within the last 3 years except for a. superficial/non-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in \> 1 year.
  • INFECTIONS: "Active infection requiring systemic therapy. "
  • VACCINATION: has received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.
  • HYPERSENSITIIVTY TO BINTRAFUSP ALFA: "Known severe hypersensitivity \[Grade ≥ 3 NCI CTCAE 5.0\]) to investigational product bintrafusp alfa or any component in its formulations, any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma.
  • CARDIOVASCULAR DISEASE: "Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication."
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum RWTH Aachen - Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Aachen, 52074, Germany

Location

Universitätsklinikum Frankfurt - Medizinische Klinik 1

Frankfurt, 60590, Germany

Location

Related Links

MeSH Terms

Conditions

Biliary Tract NeoplasmsCholangiocarcinoma

Interventions

bintrafusp alfa protein, human

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Oliver Waidmann, Prof.Dr.

    Johann Wolfgang Goethe University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 27, 2021

Study Start

July 8, 2021

Primary Completion

October 4, 2021

Study Completion

January 5, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)