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Trial record 73 of 183 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03833661
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Cholangiocarcinoma Gallbladder Cancer Drug: M7824 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : March 3, 2021
Estimated Study Completion Date : March 3, 2021


Arm Intervention/treatment
Experimental: M7824 Drug: M7824
Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity, study withdrawal, or up to 24 months
Other Name: Bintrafusp alfa




Primary Outcome Measures :
  1. Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) Assessed by Independent Review Committee (IRC) [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  2. Durable Response of at Least 6 Months According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  3. Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs) [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  4. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  5. Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  6. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  7. Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  8. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  9. Overall Survival (OS) [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  10. Concentration of M7284 at the end of Infusion (Ceoi) [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  11. Concentration of M7284 at the end of the Dosing Interval (C trough) [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  12. Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  13. Confirmed Objective Response According to RECIST Version 1.1 Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  14. Duration of Response (DOR) According to (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]
  15. Durable Response According to RECIST Version 1.1 Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression and Microsatellite instability (MSI) Status [ Time Frame: Time from first treatment to planned final assessment at approximately 2.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC.
  • Availability of tumor (primary or metastatic) archival material or fresh biopsies (collected within 28 days before first administration) of study intervention is mandatory
  • Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy
  • Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
  • Life expectancy >= 12 weeks as judged by the Investigator
  • Adequate hematological function defined by white blood cell (WBC) count >= 3 * 10^9/Litre with absolute neutrophil count (ANC) >= 1.5 * 109/Litre, lymphocyte count >= 0.5 * 10^9/Litre, platelet count >=75 * 10^9/Litre, and hemoglobin (Hgb) >= 9 grams/decilitre
  • Adequate hepatic function defined by a total bilirubin level =< 1.5 * upper limit of normal (ULN), an aspartate aminotransferase (AST) level =< 2.5 * ULN, and an alanine aminotransferase (ALT) level =<2.5 * ULN. For participants with liver involvement in their tumor, AST =< 5.0 * ULN and ALT =< 5.0 * ULN is acceptable
  • Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) =< 1.5 * ULN unless the participant is receiving anticoagulant therapy
  • Albumin >= 3.0 grams/decilitre
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
  • Adequate renal function defined by either creatinine =< 1.5 * ULN or an estimated creatinine clearance (CCr) > 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Ampullary cancer is excluded
  • Significant acute or chronic infections
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Interstitial lung disease or its history
  • Participants who are not eligible for or have not been treated with 1L systemic chemotherapy
  • Anticancer treatment within 21 days before the start of study intervention
  • Concurrent treatment with nonpermitted drugs
  • Prior participation in a M7824 clinical trial
  • Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
  • Pregnancy or breast feeding
  • Other protocol defined exclusion criteria could apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833661


Contacts
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Contact: US Medical Information +888-275-7376 service@emdgroup.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute, Inc Recruiting
Tampa, Florida, United States, 33612-9497
Contact    813-745-3596    richard.kim@moffitt.org   
Principal Investigator: Richard D Kim         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at John Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact       nazad2@jhmi.edu   
Principal Investigator: Nilofer Azad         
United States, Massachusetts
Please Contact U.S. Medical Information Not yet recruiting
Rockland, Massachusetts, United States, 02370
Contact    888-275-7376    service@emdgroup.com   
France
Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest Recruiting
Pessac Cedex, France, 33604
Contact       jean-frederic.blanc@chu-bordeaux.fr   
Principal Investigator: Jean-Frederic Blanc         
ICO - Site René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact       jean-luc.raoul@ico.unicancer.fr   
Principal Investigator: Jean-Luc Raoul         
Institut Gustave Roussy (8064) Recruiting
Villejuif cedex, France, 94805
Contact       david.malka@gustaveroussy.fr   
Principal Investigator: David Malka         
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milano (10730) Recruiting
Milano, Italy, 20133
Contact       filippo.debraud@istitutotumori.mi.it   
Principal Investigator: Filippo De Braud         
Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica Recruiting
Roma, Italy, 00168
Contact       emilio.bria@policlinicogemelli.it   
Principal Investigator: Emilio Bria         
Japan
National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology Recruiting
Chuo-ku, Japan, 104-0045
Contact       shijioka@ncc.go.jp   
Principal Investigator: Susumu Hijioka         
National Cancer Center Hospital East (12150) Recruiting
Kashiwa-shi, Japan, 277-8577
Contact       masikeda@east.ncc.go.jp   
Principal Investigator: Masafumi Ikeda         
Kyorin University Hospital - Dept of Oncology Recruiting
Mitaka-shi, Japan, 181-8611
Contact       furuse@ks.kyorin-u.ac.jp   
Principal Investigator: Junji Furuse         
Kindai University Hospital - Dept of Gastroenterology Recruiting
Osakasayama-shi, Japan, 589-8511
Contact       m-kudo@med.kindai.ac.jp   
Principal Investigator: Masatoshi Kudo         
Kanagawa Cancer Center (12952) Recruiting
Yokohama-shi, Japan, 241-8515
Contact       uenom@kcch.jp   
Principal Investigator: Makoto Ueno         
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of, 13620
Contact       jwkim@snubh.org   
Principal Investigator: Jin won Kim         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact       ohdoyoun@snu.ac.kr   
Principal Investigator: Do-Youn Oh         
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact       choihj@yuhs.ac   
Principal Investigator: Hye Jin Choi         
Asan Medical Center (7978) Recruiting
Seoul, Korea, Republic of, 05505
Contact       changhoon.yoo.amc@gmail.com   
Principal Investigator: Changhoon Yoo         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact       oncopark@skku.edu   
Principal Investigator: Joon Oh Park         
Spain
Hospital de la Santa Creu i Sant Pau (11187) Recruiting
Barcelona, Spain, 08027
Contact       mmartinri@santpau.cat   
Principal Investigator: Marta Martin-Richard         
Hospital Universitari Vall d'Hebron - Dept of Oncology Recruiting
Barcelona, Spain, 8035
Contact       hverdaguer@vhio.net   
Principal Investigator: Helena Verdaguer Mata         
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia Recruiting
Madrid, Spain, 28050
Contact       acubillo@hmhospitales.com   
Principal Investigator: Antonio Cubillo Gracian         
Taiwan
National Cheng Kung University Hospital (8257) Recruiting
Tainan, Taiwan, 704
Contact       yencj@mail.ncku.edu.tw   
Principal Investigator: Chia-Jui Yen         
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact       chihhunghsu@ntu.edu.tw   
Principal Investigator: Chih-Hung Hsu         
Chang Gung Memorial Hospital, Linkou Recruiting
Taoyuan County, Taiwan, 333
Contact       jschen1101@gmail.com   
Principal Investigator: Jen-Shi Chen         
United Kingdom
St James's University Hospital - Dept of Oncology Recruiting
Leeds, United Kingdom, LS9 7TF
Contact       fiona.collinson@nhs.net   
Principal Investigator: Fiona Collinson         
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03833661     History of Changes
Other Study ID Numbers: MS200647_0047
2018-003707-19 ( EudraCT Number )
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be is found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
M7824
Bintrafusp alfa (proposed INN)
Transforming growth factor-beta
First-line Platinum-Based Chemotherapy
Programmed death-ligand 1
Metastatic Biliary Tract Cancer
Cholangiocarcinoma
Gallbladder cancer
INTR@PID BTC 047
Additional relevant MeSH terms:
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Cholangiocarcinoma
Biliary Tract Neoplasms
Gallbladder Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases