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OUR TRIALS

Welcome to INTR@PID Clinical Trials – a program investigating the anticancer effect of potential concomitant inhibition of TGF-β and PD-L1 with bintrafusp alfa (M7824) in multiple tumor 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:

Now Enrolling


BTC 047

ADVANCED

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-based chemotherapy.

ClinicalTrials.gov: NCT03833661

Location: Global

Status:

Active, Not Recruiting


BTC 055

ADVANCED

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

PHASE 2

MONOTHERAPY


A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with advanced, unresectable cervical cancer that progressed during or after platinum-containing chemotherapy.*

ClinicalTrials.gov: NCT04246489

Location: Global

Status:

Now Enrolling


* Prior platinum-containing chemotherapy may be a systemic treatment for metastatic disease or in the adjuvant or neoadjuvant setting. Participants who were intolerant to or ineligible for platinum-based chemotherapy are also eligible for this study.


UROTHELIAL 152

ADVANCED

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

Locations: Not yet available

Status:

Active, Not Recruiting



*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. 


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

 

 

   

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