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PD-L1/TGF-beta Trap

M7824 vs Pembrolizumab for Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first treatment assessed up to approximately 843 days
Awards & highlights

Study Summary

This trial will compare the effectiveness of two drugs for treating patients with advanced lung cancer.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1, but without EGFR mutations or ALK translocations. Participants should not have had prior treatments for stage four NSCLC, though past neoadjuvant/adjuvant therapy is acceptable if completed over six months ago and any side effects are minimal. They must have a life expectancy of at least three months and available recent tumor tissue to confirm PD-L1 status.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of two drugs: M7824 (bintrafusp alfa) and pembrolizumab in patients with advanced NSCLC who express high levels of PD-L1. It's a Phase III trial where up to 584 patients may be enrolled based on specific rules, randomly assigned to receive either M7824 or pembrolizumab as their first-line treatment.See study design
What are the potential side effects?
Potential side effects include hypersensitivity reactions related to the investigational products (M7824 or pembrolizumab), which could involve severe allergic responses. Other common side effects from similar therapies might include fatigue, skin reactions, immune-related issues affecting organs like the liver or lungs, infusion-related symptoms, and possible complications from previous surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a recent (less than 6 months old) tumor tissue sample for testing.
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I haven't had systemic therapy for my stage 4 NSCLC, but finished other treatments over 6 months ago with minimal side effects.
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My lung cancer is confirmed and advanced.
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My cancer has a high PD-L1 status.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first treatment assessed up to approximately 843 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first treatment assessed up to approximately 843 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Secondary outcome measures
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Percentage of Participants With Unconfirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

Side effects data

From 2023 Phase 1 & 2 trial • 21 Patients • NCT04247282
43%
Oral hemorrhage
36%
Constipation
36%
Fatigue
36%
Lymphocyte count decreased
36%
Epistaxis
29%
Dysphagia
29%
Weight loss
21%
Hyperglycemia
21%
Pruritus
21%
Wound infection
21%
Anemia
14%
Hyperthyroidism
14%
Lipase increased
14%
Rash acneiform
14%
White blood cell decreased
14%
Creatinine increased
14%
Gait disturbance
14%
Rash maculo-papular
14%
Tumor hemorrhage
14%
Alanine aminotransferase increased
14%
Oral pain
7%
Palpitations
7%
Aspartate aminotransferase increased
7%
Blood bilirubin increased
7%
Cough
7%
Flu like symptoms
7%
Hyponatremia
7%
Hypoxia
7%
Intraoperative head and neck injury
7%
Vaccination site lymphadenopathy
7%
Gastrointestinal disorders - Other, Sialadenitis
7%
Hematuria
7%
Respiratory failure
7%
Atrial fibrillation
7%
CPK increased
7%
Dermatitis radiation
7%
GGT increased
7%
Hypermagnesemia
7%
Hypophosphatemia
7%
Nausea
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Peripheral sensory neuropathy
7%
Aphonia
7%
Dehydration
7%
Edema limbs
7%
Mucositis oral
7%
Tumor pain
7%
Lung infection
7%
Sinus tachycardia
7%
Vasculitis
7%
Alkaline phosphatase increased
7%
Dysarthria
7%
Dysesthesia
7%
Dysgeusia
7%
Hypothyroidism
7%
Pain
7%
Skin ulceration
7%
Stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15)
Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1)
Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: M7824Experimental Treatment1 Intervention
Group II: PembrolizumabActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M7824
2020
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,556 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
435 Previous Clinical Trials
114,318 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,694 Total Patients Enrolled

Media Library

M7824 (PD-L1/TGF-beta Trap) Clinical Trial Eligibility Overview. Trial Name: NCT03631706 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: M7824, Pembrolizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: M7824 Highlights & Side Effects. Trial Name: NCT03631706 — Phase 3
M7824 (PD-L1/TGF-beta Trap) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03631706 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the current research landscape look like for M7824?

"City of Hope first studied M7824 in 2010. So far, there have been 251 completed studies and 999 active trials. There is a significant presence of these trials in Rochester, New york."

Answered by AI

What kind of side effects does M7824 have on patients?

"M7824's safety is based on extensive clinical data from Phase 3 trials, and it is estimated to be a 3 on a scale of 1 to 3."

Answered by AI

Are there multiple research facilities conducting this trial in Canada?

"28 clinical trial sites are active, with locations including the University of Rochester Medical Center, UPMC Cancer Center, and Baptist Health Lexington Oncology Associates."

Answered by AI

Are there any available spots for patients who want to enroll in this trial?

"This particular trial is not searching for patients at this time, as the last update to the study was on July 4th, 2022. However, there are 1984 trials for patients with carcinoma, non-small-cell lung and 999 trials for M7824 that are currently enrolling participants."

Answered by AI

What are the approved indications for M7824?

"M7824 is most frequently used to treat malignant neoplasms, but it can also be used to treat unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

How many people can enroll in this trial at most?

"This study has completed recruitment and is no longer looking for participants. The trial was first posted on 2018-10-01 and was most recently updated on 2022-07-04. However, there are presently 1984 studies actively enrolling participants with carcinoma, non-small-cell lung and 999 trials for M7824 actively searching for participants."

Answered by AI
~47 spots leftby Mar 2025