A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer

NCT04349280 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 213152
• Study Type: interventional
• Target: 25
• Locations: 5 countries
• Sites: 12

Brief Summary

The purpose of this study is to evaluate bintrafusp alfa in participants with metastatic or locally advanced urothelial cancer. This trial provides the first evaluation of bintrafusp alfa in participants with urothelial cancer that has progressed following platinum therapy.

Conditions

Neoplasms

Keywords

Bintrafusp Alfa; Platinum Agent; Response Evaluation Criteria in Solid Tumors; Urothelial Cancer; M7824

Outcome Measures

Primary Outcomes (1)

• Confirmed Overall Response Rate (ORR) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Confirmed overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).

  Up to approximately 22 months

Secondary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)

  Up to approximately 22 months

• Number of Participants With Worst Grade Treatment Emergent AEs

  Up to approximately 22 months

Study Arms (1)

Participants receiving bintrafusp alfa

EXPERIMENTAL

Participants will receive bintrafusp alfa.

Drug: Bintrafusp alfa

Interventions

Bintrafusp alfa DRUG

Participants will receive bintrafusp alfa.

Participants receiving bintrafusp alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants can give signed informed consent/assent.
• Participants with histologically confirmed locally advanced or metastatic or locally advanced/unresectable urothelial carcinoma (including renal, pelvis, ureter, urinary bladder, urethra).
• Able to provide, a tumor tissue sample collected during screening and prior to administration of bintrafusp alfa.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
• Participants with adequate organ system functions.
• Life expectancy of at least 12 weeks.
• A female is eligible if she is not pregnant or breastfeeding.

You may not qualify if:

• Active brain and/or leptomeningeal disease that is symptomatic or requires therapeutic intervention. Participants with asymptomatic central nervous system (CNS) metastases who are clinically stable as demonstrated by serial brain images and have no requirement for corticosteroids for at least 14 days prior to enrollment are eligible.
• History of malignancy other than urothelial cancer within the last 3 years except for localized tumors that have been treated with curative intent or have not required therapy in the past 2 years. (e.g., resected non-melanoma skin cancer).
• No more than 2 lines of systemic therapy for the treatment of metastastic disease. If the most recent therapy was not a platinum-based regimen, the participant must have progressed on or after that therapy.
• Cirrhosis or current unstable liver or biliary disease per investigator assessment.
• Current pneumonitis or history of non-infectious pneumonitis that required systemic immunosuppressive treatment.
• Active autoimmune disease that required systemic immunosuppressive treatment within the past 2 years.
• Received prior allogeneic/autologous bone marrow or solid organ transplant.
• Receiving systemic corticosteroids (\>10 milligrams \[mg\] daily oral prednisone or equivalent) or other immunosuppressive agent within 7 days prior to study treatment. Inhaled or topical steroids are permitted.
• Known severe hypersensitivity reactions to monoclonal antibodies or any ingredient used in the study treatment formulation (Grade \>=3 National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0).
• Active infection requiring systemic therapy.
• Received any live vaccine within 30 days prior first dose of intervention.
• Known history of positive test for human immunodeficiency virus (HIV) with the exception of participants with cluster of differentiation 4 (CD4) + T-cell (CD4+) counts \>=350 cells per microliter (cells /uL) and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.
• Active hepatitis B virus (HBV) (HBV surface antigen-positive).
• Active hepatitis C virus (HCV) infection, or positive HCV antibody, with the exception of participants that 1. Have HCV viral load below the limits of quantitation and 2. Completed curative antiviral therapy or are receiving and compliant with antiviral therapy.
• History or evidence of cardiac abnormalities within the 6 months prior to first dose of intervention.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (12)

GSK Investigational Site

Lake Success, New York, 11041, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45229, United States

Location

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

GSK Investigational Site

Bordeaux, 33000, France

Location

GSK Investigational Site

Poitiers, 86021, France

Location

GSK Investigational Site

Toulouse, 31059, France

Location

GSK Investigational Site

Villejuif, 94805, France

Location

GSK Investigational Site

Amsterdam, 1066 CX, Netherlands

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

bintrafusp alfa protein, human

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single arm study.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 16, 2020
• Study Start: October 15, 2020
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (2); FR (4); ES (4); CA (1); NL (1)