Leaving INTR@PID website

You are leaving INTR@PID Clinical Trials page. This link will take you to a website where our Terms of Use do not apply. Merck KGaA, Darmstadt, Germany has no control over the contents and policies of these sites or resources, and accepts no responsibility for your use of them.

Please Confirm

This website is an information resource intended only for Healthcare Professionals from the U.S., who are interested in information on Clinical Research and EMD Serono and GSK sponsored clinical trials.

By clicking "I am a healthcare professional" you are declaring and confirming that you are a Healthcare Professional inside the U.S., and have read and understood this disclaimer.

 

Images shown are models for illustrative purposes only

OUR TRIALS

Welcome to INTR@PID Clinical Trials - a program investigating the effect of bintrafusp alfa, a bifunctional fusion protein designed to target tumors via colocalized, simultaneous inhibition of the TGF-β and PD-L1 pathways, in multiple cancer types.

Bintrafusp alfa is under clinical investigation and has not been proven to be safe and effective. There is no guarantee that bintrafusp alfa will be approved in the sought-after indication by any health authority worldwide.


Find out more about each of our trials below.



LUNG 037

STAGE IV

PHASE 3
RANDOMIZED

MONOTHERAPY


An adaptive phase 3, randomized, open-label, controlled study evaluating bintrafusp alfa versus pembrolizumab in the first-line treatment of patients with stage IV non-small cell lung cancer (NSCLC) that has high expression of PD-L1.*

ClinicalTrials.govNCT03631706

Location: Global

Status:

Active, Not Recruiting


*PD-L1–high expression as determined by central testing. 


LUNG 005

STAGE III

PHASE 2
RANDOMIZED

COMBINATION
THERAPY


A phase 2, randomized, controlled study evaluating bintrafusp alfa with concurrent chemoradiation (cCRT) followed by bintrafusp alfa versus placebo with cCRT followed by durvalumab for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC). 

ClinicalTrials.gov: NCT03840902

Location: Global

Status:

Now Enrolling


LUNG 024

STAGE IV

PHASE 1/2

COMBINATION
THERAPY


A phase 1b/2, open-label study evaluating bintrafusp alfa with chemotherapy for the treatment of patients with stage IV non-small cell lung cancer (NSCLC). 

ClinicalTrials.gov: NCT03840915

Locations: Europe and North America

Status:

Active, Not Recruiting


BTC 047

LOCALLY ADVANCED/
METASTATIC

PHASE 2

MONOTHERAPY


A phase 2, single-arm study evaluating bintrafusp alfa in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) who have failed or are intolerant to first-line platinum-containing chemotherapy.

ClinicalTrials.gov: NCT03833661

Location: Global

Status:

Active, Not Recruiting


BTC 055

LOCALLY ADVANCED/
METASTATIC

PHASE 2/3
RANDOMIZED

COMBINATION
THERAPY


A safety run-in followed by a phase 2/3, randomized, placebo-controlled study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).

ClinicalTrials.gov: NCT04066491

Location: Global

Status:

Now Enrolling


CERVICAL 017

ADVANCED/
METASTATIC

PHASE 2

MONOTHERAPY


A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with advanced unresectable and/or metastatic cervical cancer who had disease progression with platinum-containing chemotherapy.*

ClinicalTrials.gov: NCT04246489

Location: Global

Status:

Active, Not Recruiting


*Platinum-containing chemotherapy may have been a systemic treatment for advanced unresectable, recurrent, persistent, or metastatic disease, or given in the adjuvant/neoadjuvant setting with disease progression or recurrence within 6 months of treatment completion. Patients who previously only received platinum as a radlosensitizer are not eligible.


CERVICAL 046

ADVANCED

PHASE 1

 

COMBINATION THERAPY

A phase 1, open-label study evaluating bintrafusp alfa with other anticancer therapies for the treatment of patients with locally advanced or persistent, recurrent, or metastatic cervical cancer.

ClinicalTrials.gov: NCT04551950

Location: Global

Status:

Now Enrolling


UROTHELIAL 152

LOCALLY ADVANCED/
METASTATIC

PHASE 1

MONOTHERAPY

A phase 1b, single-arm study evaluating bintrafusp alfa for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer that progressed or recurred after platinum-containing chemotherapy.* 

ClinicalTrials.gov: NCT04349280

GSK213152

Locations: Europe and North America

Status:

Now Enrolling


*Must have experienced disease progression or recurrence either following platinum-containing chemotherapy given for unresectable locally advanced or metastatic urothelial cancer or within 12 months from completion of neoadjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive urothelial cancer.


BREAST 020

METASTATIC

PHASE 2

MONOTHERAPY

A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with metastatic triple-negative breast cancer (TNBC) that has high expression of HMGA2.*

ClinicalTrials.gov: NCT04489940

Locations: Europe and North America

Status:

Now Enrolling


*HMGA2-high tumor expression will be determined by a centralized RT-PCR test.


SOLID TUMOR 001

ADVANCED

PHASE 1

MONOTHERAPY


A phase 1, open-label, multiple ascending-dose trial to investigate the safety, tolerability, pharmacokinetics, and biological and clinical activity of bintrafusp alfa in patients with metastatic or locally advanced solid tumors and expansion to selected indications.

ClinicalTrials.gov: NCT02517398

Location: Global

Status:

Active, Not Recruiting


SOLID TUMOR 008

ADVANCED

PHASE 1

MONOTHERAPY


A phase 1, open-label, multiple ascending-dose trial to investigate the safety, tolerability, pharmacokinetics, and biological and clinical activity of bintrafusp alfa in patients with metastatic or locally advanced solid tumors, with expansion to selected indications in Asia.

ClinicalTrials.gov: NCT02699515

Location: Asia

Status:

Active, Not Recruiting

 

 

   

Explore the Knowledge Base