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PD-L1/TGF-beta Trap

M7824 for Head and Neck Cancers

Phase 1 & 2

Waitlist Available

Led By Jason M Redman, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks or more beyond surgery, up to 2 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of immunotherapy drugs given before surgery for people with head and neck cancer.

Eligible Conditions

Head and Neck Cancers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks or more beyond surgery, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks or more beyond surgery, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks or more beyond surgery, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Experience Clinical to Pathologic Downstaging Upon Analysis of Resected Tumor After Completing Study Treatments

Number of Participants Who Experience a Pathologic Complete Response (pCR)

Secondary outcome measures

Number of Participants That Experienced Grade 3 or 4 Immune Related Adverse Events (irAEs)

Number of Participants With Treatment-related Adverse Events Causing a Delay of 4 Weeks or More Beyond Planned Surgery

Percentage of Participants Who Are Alive

+2 more

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

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

Palpitations

Aspartate aminotransferase increased

Blood bilirubin increased

Cough

Flu like symptoms

Hyponatremia

Hypoxia

Intraoperative head and neck injury

Vaccination site lymphadenopathy

Gastrointestinal disorders - Other, Sialadenitis

Hematuria

Respiratory failure

Atrial fibrillation

CPK increased

Dermatitis radiation

GGT increased

Hypermagnesemia

Hypophosphatemia

Nausea

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Peripheral sensory neuropathy

Aphonia

Dehydration

Edema limbs

Mucositis oral

Tumor pain

Lung infection

Sinus tachycardia

Vasculitis

Alkaline phosphatase increased

Dysarthria

Dysesthesia

Dysgeusia

Hypothyroidism

Pain

Skin ulceration

Stroke

100%

80%

60%

40%

20%

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

3Treatment groups

Experimental Treatment

Group I: Arm C, Cohort 1 M7824 + TriAd Vaccine (Day 1) + N-803 (Day 1)Experimental Treatment3 Interventions

M7824 + TriAd vaccine (Day 1) + N-803 (Day 1)

Group II: Arm B, Cohort 1 M7824 + TriAd Vaccine (ETBX-011, ETBX-051 & ETBX-061) (Day 1)Experimental Treatment2 Interventions

M7824 + TriAd vaccine (ETBX-011, ETBX-051 and ETBX-061) (Days 1)

Group III: Arm A, Cohort 1 Bintrafusp Alfa (M7824) (Days 1, 15)Experimental Treatment1 Intervention

M7824 (Days 1, 15)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

M7824

2020

Completed Phase 2

~350

N803

2020

Completed Phase 2

~30

TriAd vaccine

2020

Completed Phase 2

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,621 Total Patients Enrolled

Jason M Redman, M.D.Principal InvestigatorNational Cancer Institute (NCI)

4 Previous Clinical Trials

262 Total Patients Enrolled

Frequently Asked Questions

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

Has a trial like this ever been conducted before?

"Currently, 20 clinical trials are active for M7824 in 332 cities located within one jurisdiction. ImmunityBio Inc.'s original study on the drug began back in 2014 and included 596 subjects over two phases of safety testing. Since then, 11 further studies have been concluded."

Answered by AI

Does this experiment currently accept participants?

"This trial has ceased recruitment, having been posted on June 9th 2020 and last updated October 5th 2022. Thankfully there are other avenues of exploration; 1195 studies concerning head neoplasms remain open to participants while 20 trials involving M7824 actively accept new enrollees."

Answered by AI

Has the drug M7824 been subject to previous research trials?

"Presently, 20 trials are underway to evaluate the effects of M7824 with 3 in Phase 3. Despite a few being located close by Ann Arbor, Michigan, an impressive 508 sites have been recruited for this study's investigational purposes."

Answered by AI

How many individuals are being recruited into this medical research project?

"Unfortunately, this medical trial is no longer enrolling patients. It was initially posted on the 9th of June 2020 and its description was last revised on October 5th 2022. For those seeking alternative studies, 1195 trials are actively recruiting participants with head neoplasms while 20 trials are welcoming M7824 patients into their research."

Answered by AI

Recent research and studies

Current Opinion in OncologyJournal

The Role of the Tumor Matrix Environment in Progression of Head and Neck Cancer

Saint, Angélique, and Ellen Van Obberghen-Schilling. 2021. “The Role of the Tumor Matrix Environment in Progression of Head and Neck Cancer”. Current Opinion in Oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/cco.0000000000000730.

Journal of Clinical InvestigationJournal

Enhanced Neoepitope-specific Immunity Following Neoadjuvant PD-L1 and Tgf-β Blockade in Hpv-unrelated Head and Neck Cancer

Redman, Jason M., Jay Friedman, Yvette Robbins, Cem Sievers, Xinping Yang, Wiem Lassoued, Andrew Sinkoe, et al.. 2022. “Enhanced Neoepitope-specific Immunity Following Neoadjuvant PD-L1 and Tgf-β Blockade in Hpv-unrelated Head and Neck Cancer”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci161400.

clinicaltrials.govStudy

Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection

Jason Redman 2020. "Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04247282.