← Back to Search

Immunotherapy

M7824, M9241, and SBRT for Genitourinary Cancer

Phase 1
Recruiting
Led By Andrea B Apolo, 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
Participants may have been previously treated with radiation therapy. However, re-irradiation of a previously irradiated site is not permitted unless explicitly discussed with protocol PI and treating radiation oncologist
Subjects with locally advanced/metastatic clear cell renal cell cancer must have previously received, refused or been ineligible for either axitinib plus pembrolizumab, cabozantinib plus nivolumab, levantinib plus pembrolizumab, axitinib plus avelumab, nivolumab plus ipilumumab, cabozantinib, pazopanib, sunitinib or axitinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time measurement criteria are met for cr or pr (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
Awards & highlights

Study Summary

This trial is testing if two drugs, M7824 and M9241, can help the immune system fight cancer when given with or without radiation therapy.

Who is the study for?
Adults over 18 with genitourinary cancers (excluding prostate cancer) that have spread, who can provide a tumor sample and are not pregnant or breastfeeding. Participants must be able to perform daily activities, have adequate organ function, agree to use contraception, and may have had prior treatments but not with M7824/M9241.Check my eligibility
What is being tested?
The trial is testing the effectiveness of two drugs, M7824 and M9241 alone or combined with SBRT radiation therapy in treating metastatic non-prostate genitourinary cancers. The goal is to see if these treatments improve the immune system's ability to fight cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from IV treatment, fatigue, blood disorders which could affect overall health and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had radiation therapy before, but not on the same area twice.
Select...
I have advanced kidney cancer and cannot take standard treatments.
Select...
I have at least one cancer spot that can be measured and won't be treated with radiation.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years or older and have given my consent to participate.
Select...
I have advanced testicular cancer and cannot have standard chemotherapy or a stem cell transplant.
Select...
I have previously undergone chemotherapy or targeted therapy for my condition.
Select...
I am on stable HCV treatment without significant liver issues.
Select...
I have a recent tissue sample for PD-L1 testing or am willing to get a biopsy.
Select...
I have hepatitis B and am on a stable dose of specific antivirals.
Select...
I am HIV-positive, on stable HAART, with CD4 counts over 350 and an undetectable viral load.
Select...
I had brain or CNS cancer treatment, am off steroids, and it's been 2 weeks since my last radiation.
Select...
My hemoglobin level is at least 9g/dL, transfusions included.
Select...
I have had immunotherapy but not with M7824 or M9241.
Select...
I have advanced bladder cancer and cannot have or have already had certain chemotherapy or immunotherapy.
Select...
I can have radiation on up to 4 areas of my cancer.
Select...
My liver tests are within the required limits for the study.
Select...
My cancer has spread, confirmed by recent scans.
Select...
I am willing to use effective birth control during and after the treatment for the specified periods.
Select...
My cancer in the urinary system has spread and was confirmed by lab tests.
Select...
My liver function is mildly to moderately impaired, with bilirubin levels not exceeding three times the upper limit.
Select...
My organs and bone marrow are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until confirmed progression, unacceptable toxicity or trial withdrawal
This trial's timeline: 3 weeks for screening, Varies for treatment, and until confirmed progression, unacceptable toxicity or trial withdrawal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
safety and tolerability of M9241 and M7824 alone or in combination with SBRT
Secondary outcome measures
Objective response rate (ORR)
Overall Survival (OS)
Progression free survival (PFS)

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

3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment3 Interventions
Treatment with M7824 and de-escalating doses of M9241 (if appropriate) with concurrent SBRT
Group II: Arm 2Experimental Treatment3 Interventions
Treatment with M7824 and de-escalating doses of M9241 (if appropriate) with sequential SBRT
Group III: Arm 1Experimental Treatment2 Interventions
Treatment with M7824 and de-escalating doses of M9241 if appropriate
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?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,281 Total Patients Enrolled
1 Trials studying Urogenital Cancer
1,000 Patients Enrolled for Urogenital Cancer
Andrea B Apolo, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
1,302 Total Patients Enrolled
1 Trials studying Urogenital Cancer
1,000 Patients Enrolled for Urogenital Cancer

Media Library

Bintrafusp Alfa (M7824) (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04235777 — Phase 1
Urogenital Cancer Research Study Groups: Arm 1, Arm 2, Arm 3
Urogenital Cancer Clinical Trial 2023: Bintrafusp Alfa (M7824) Highlights & Side Effects. Trial Name: NCT04235777 — Phase 1
Bintrafusp Alfa (M7824) (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04235777 — Phase 1

Frequently Asked Questions

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

Are there any remaining openings for participants in this research project?

"Affirmative. According to the listing on clinicaltrials.gov, this medical trial was posted back in July 2020 and has since been actively recruiting patients. This study requires 66 participants from a single site."

Answered by AI

Has the FDA sanctioned M7824 for public use?

"Based on the limited data available, our team at Power assessed the safety of M7824 as a 1. This is due to it being in Phase 1 of clinical trials and having only preliminary evidence supporting its efficacy and safety."

Answered by AI

How many people are currently engaged in this trial?

"Indeed, the information on clinicaltrials.gov indicates that this research study is currently recruiting participants. It was first posted on July 13th 2020 and last revised on November 5th 2022 with 66 individuals needed from 1 site."

Answered by AI
~10 spots leftby Dec 2024