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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 must have at least one measurable site of disease that will not be irradiated
ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
Must not have
Subjects unwilling to accept blood products as medically indicated
Participants having tumor lesion(s) in the liver or chest which are 10 cm or larger.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from treatment to the date of death from any cause
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I have at least one cancer spot that can be measured and won't be treated with radiation.
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I can take care of myself but might not be able to do heavy physical work.
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I have advanced testicular cancer and cannot have standard chemotherapy or a stem cell transplant.
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I have hepatitis B and am on a stable dose of specific antivirals.
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I have advanced bladder cancer and cannot have or have already had certain chemotherapy or immunotherapy.
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My liver tests are within the required limits for the study.
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My cancer in the urinary system has spread and was confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unwilling to receive blood products even if needed for my treatment.
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I have a tumor in my liver or chest that is larger than 10 cm.
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I am not pregnant or breastfeeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
safety and tolerability of PDS01ADC and M7824 alone or in combination with SBRT
Secondary study objectives
Objective response rate (ORR)
Overall Survival (OS)
Progression free survival (PFS)

Side effects data

From 2024 Phase 3 trial • 304 Patients • NCT03631706
34%
Pruritus
32%
Rash
30%
Anaemia
20%
Fatigue
19%
Dyspnoea
19%
Pyrexia
18%
Haemoptysis
17%
Asthenia
17%
Decreased appetite
16%
Diarrhoea
15%
Aspartate aminotransferase increased
15%
Cough
13%
Gamma-glutamyltransferase increased
13%
Arthralgia
13%
Nausea
13%
Alanine aminotransferase increased
12%
Blood alkaline phosphatase increased
11%
Hypothyroidism
11%
Insomnia
11%
Rash maculo-papular
11%
Constipation
11%
Hypoalbuminaemia
10%
Epistaxis
9%
Oedema peripheral
9%
Vomiting
9%
Headache
9%
Hyperglycaemia
8%
Keratoacanthoma
8%
Dizziness
8%
Lipase increased
7%
Hyponatraemia
7%
Myalgia
7%
Urinary tract infection
7%
Hypotension
7%
Weight decreased
6%
Pneumonia
6%
Dry Skin
6%
Blood bilirubin increased
6%
Blood creatinine increased
6%
Upper respiratory tract infection
6%
Amylase increased
6%
Hyperuricaemia
5%
Rash pruritic
5%
Hyperkeratosis
5%
Productive cough
5%
Back pain
5%
Chest pain
4%
Hyperthyroidism
4%
Disease progression
3%
Hypokalaemia
3%
Hypomagnesaemia
3%
Pneumothorax
3%
Squamous cell carcinoma of skin
3%
Dyspepsia
2%
Hypertension
2%
Pulmonary haemorrhage
2%
Keratoacanthom
2%
Abdominal pain upper
1%
Tumour haemorrhage
1%
Myopathy
1%
Stevens-Johnson syndrome
1%
Sudden death
1%
Troponin increased
1%
Skin infection
1%
Blood thyroid stimulating hormone increased
1%
Death
1%
Skin toxicity
1%
Fluid overload
1%
Bladder cancer
1%
Cancer pain
1%
Acute myocardial infarction
1%
Infusion related reaction
1%
Platelet count decreased
1%
Aplastic anaemia
1%
Autoimmune haemolytic anaemia
1%
Fall
1%
Iron deficiency anaemia
1%
Oesophageal ulcer
1%
Arrhythmia
1%
Influenza
1%
Hypercalcaemia
1%
Coronary artery disease
1%
Malaise
1%
Infection
1%
Pneumonia staphylococcal
1%
Fractured sacrum
1%
Chronic obstructive pulmonary disease
1%
Hypoxia
1%
Pleural effusion
1%
Pneumonitis
1%
Drug eruption
1%
Eczema
1%
Toxic skin eruption
1%
Embolism
1%
Superior vena cava syndrome
1%
Agranulocytosis
1%
Angina pectoris
1%
Fracture pain
1%
Spondylitis
1%
Cerebral infarction
1%
Renal failure
1%
Lichen planus
1%
Immune-mediated enterocolitis
1%
Pericardial effusion
1%
Immune thrombocytopenia
1%
Adrenal insufficiency
1%
Oral candidiasis
1%
Bile duct stone
1%
Cholecystitis
1%
Immune-mediated nephritis
1%
Aortic aneurysm
1%
Transaminases increased
1%
Bacterial sepsis
1%
Bronchitis
1%
Strangulated incisional hernia
1%
Thoracic vertebral fracture
1%
Encephalitis
1%
Pulmonary sepsis
1%
Diabetes mellitus
1%
Sciatica
1%
Asthma
1%
Dermatitis bullous
1%
Hypersensitivity
1%
Cholestasis
1%
Hyperthermia
1%
Hepatotoxicity
1%
Lower respiratory tract infection
1%
Colitis
1%
Viral upper respiratory tract infection
1%
Urinary tract infection bacterial
1%
Pancreatitis
1%
General physical health deterioration
1%
Duodenitis
1%
Upper gastrointestinal haemorrhage
1%
Gastric ulcer haemorrhage
1%
Gastrointestinal haemorrhage
1%
Hepatitis
1%
Hip fracture
1%
Bladder transitional cell carcinoma
1%
Erythema
1%
Pemphigoid
1%
Respiratory failure
1%
Interstitial lung disease
1%
Erythema multiforme
1%
Orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
M7824
Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment3 Interventions
Treatment with M7824 and de-escalating doses of PDS01ADC (if appropriate) with concurrent SBRT
Group II: Arm 2Experimental Treatment3 Interventions
Treatment with M7824 and de-escalating doses of PDS01ADC (if appropriate) with sequential SBRT
Group III: Arm 1Experimental Treatment2 Interventions
Treatment with M7824 and de-escalating doses of PDS01ADC if appropriate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M7824
2018
Completed Phase 3
~710

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,112,008 Total Patients Enrolled
1 Trials studying Genitourinary Cancers
275 Patients Enrolled for Genitourinary Cancers
Andrea B Apolo, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
1,402 Total Patients Enrolled

Media Library

Bintrafusp Alfa (M7824) (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04235777 — Phase 1
Genitourinary Cancers Research Study Groups: Arm 3, Arm 1, Arm 2
Genitourinary Cancers 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
~40 spots leftby Dec 2027
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