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OUR TRIALS

Welcome to INTR@PID Clinical Trials – a program to investigate the 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 2
RANDOMIZED

MONOTHERAPY


A phase 2, randomized, multicenter, open-label study comparing bintrafusp alfa with pembrolizumab in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1* expression.

ClinicalTrials.govNCT03631706

Location: Global

Status:

Now enrolling


* PD-L1–high expression as determined by central PD-L1 test or by prior testing using the PD-L1 IHC 22C3 pharmDx assay.


LUNG 005

STAGE III

PHASE 2
RANDOMIZED

COMBINATION
THERAPY


A phase 2, multicenter, double-blind, randomized, controlled study evaluating bintrafusp alfa with concurrent chemoradiation (cCRT) followed by bintrafusp alfa vs placebo plus cCRT followed by durvalumab in patients with unresectable stage III NSCLC.

ClinicalTrials.gov: NCT03840902

Locations: North America, Europe, and Asia

Status:

Now enrolling


LUNG 024

STAGE IV

PHASE 1/2

COMBINATION
THERAPY


A phase 1b/2, open-label study evaluating bintrafusp alfa in combination with chemotherapy in patients with stage IV NSCLC.

ClinicalTrials.gov: NCT03840915

Locations: North America and Europe

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:

Now enrolling


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:

Active, not recruiting


* 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.


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

Locations: North America, Australia, Europe and Asia

Status:

Now enrolling


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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