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M9241 + SBRT for Prostate Cancer
Phase 2
Recruiting
Led By Ravi A Madan, 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 prostate cancer accessible for biopsy
Male age >= 18 years old
Must not have
Contraindications for SBRT such as rectal wall invasion, history of inflammatory bowel disease
Initiation of ADT or SBRT or pelvic nodal radiation irradiation prior to trial enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks after start of treatment
Awards & highlights
Summary
This trial is testing a new drug (M9241) to see if it is safe and if it can help the immune system to fight prostate cancer.
Who is the study for?
Men over 18 with intermediate or high-risk prostate cancer that hasn't spread are eligible. They need to have certain levels of blood cells, liver and kidney function, and agree to use contraception. Excluded are those with HIV, active hepatitis, other recent cancers (except some skin/cervical/breast/prostate), previous prostate treatments, immune deficiencies/autoimmune diseases, allergies to M9241 or SBRT contraindications.
What is being tested?
The trial tests if the drug M9241 can boost the immune system against prostate cancer when added to standard radiation therapy and ADT. Participants will receive either just radiation and ADT or these plus three doses of M9241 injections after radiation ends. The study lasts 7 months with follow-ups for safety and effectiveness.
What are the potential side effects?
Potential side effects include typical reactions at injection sites like pain or swelling, possible flu-like symptoms such as fever or fatigue due to immune activation by M9241, organ inflammation risks from immunotherapy agents in general, and common radiation therapy side effects like skin irritation or digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer can be biopsied.
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I am a man aged 18 or older.
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My organs and bone marrow are working well.
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I need SBRT and hormone therapy for my prostate cancer.
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I can do most of my daily activities without help.
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My prostate cancer is confirmed and is at an intermediate or high risk level.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have conditions like inflammatory bowel disease that prevent SBRT.
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I have started hormone therapy or radiation treatment before joining this trial.
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I haven't had any cancer except for treatable ones in the last 3 years.
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I have an active immune deficiency, chronic inflammation, or autoimmune disease, or I am on long-term immunosuppressive therapy.
Select...
I have had surgery or radiation for prostate cancer.
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I have health conditions that prevent me from receiving hormone therapy for cancer.
Select...
I do not have any serious infections, including tuberculosis.
Select...
My cancer has spread to distant parts of my body.
Select...
I do not have an active Hepatitis B or C infection.
Select...
I am currently taking steroids or medications that suppress my immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 4 weeks after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 4 weeks after end of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine safety and tolerated doses of M9241 and SBRT
evaluate T-cell clonality as measures of immunologic activity
Secondary study objectives
Evaluate peripheral immune response
Side effects data
From 2018 Phase 2 trial • 35 Patients • NCT0136059321%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT
Trial Design
3Treatment groups
Experimental Treatment
Group I: 3/Arm 2bExperimental Treatment1 Intervention
SBRT
Group II: 2/Arm 2aExperimental Treatment2 Interventions
Highest tolerated dose of M941+SBRT
Group III: 1/Arm 1Experimental Treatment2 Interventions
De-escalating doses of M9241 if appropriate + SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,935 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,744 Patients Enrolled for Prostate Cancer
Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
17 Previous Clinical Trials
1,084 Total Patients Enrolled
11 Trials studying Prostate Cancer
922 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer can be biopsied.I don't have conditions like inflammatory bowel disease that prevent SBRT.I have started hormone therapy or radiation treatment before joining this trial.I haven't had any cancer except for treatable ones in the last 3 years.I have an active immune deficiency, chronic inflammation, or autoimmune disease, or I am on long-term immunosuppressive therapy.I have had surgery or radiation for prostate cancer.I am a man aged 18 or older.I have health conditions that prevent me from receiving hormone therapy for cancer.My organs and bone marrow are working well.I need SBRT and hormone therapy for my prostate cancer.I do not have any serious infections, including tuberculosis.My cancer has spread to distant parts of my body.I can do most of my daily activities without help.I do not have an active Hepatitis B or C infection.I have or will provide a tissue sample for testing before treatment starts.I agree to use contraception for 6 months after my treatment ends.I am currently taking steroids or medications that suppress my immune system.My prostate cancer is confirmed and is at an intermediate or high risk level.I have not received any live vaccines in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1
- Group 2: 2/Arm 2a
- Group 3: 3/Arm 2b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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