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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four weeks after start of treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 4 weeks after end of treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine safety and tolerated doses of M9241 and SBRT

evaluate T-cell clonality as measures of immunologic activity

Secondary outcome measures

Evaluate peripheral immune response

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,789 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,030 Patients Enrolled for Prostate Cancer

Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)

17 Previous Clinical Trials

1,073 Total Patients Enrolled

11 Trials studying Prostate Cancer

911 Patients Enrolled for Prostate Cancer

Media Library

Stereotactic Body Radiation Therapy (SBRT) Clinical Trial Eligibility Overview. Trial Name: NCT05361798 — Phase 2

Prostate Cancer Research Study Groups: 1/Arm 1, 2/Arm 2a, 3/Arm 2b

Prostate Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT05361798 — Phase 2

Stereotactic Body Radiation Therapy (SBRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361798 — Phase 2

Frequently Asked Questions

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

How many participants can the trial accommodate in total?

"Affirmative. According to the information located on clinicaltrials.gov, this trial is currently enrolling participants and was initially announced on December 5th 2022; it has since been updated as of November 29th 2022. This study requires 65 patients from one medical site."

Answered by AI

Does this research trial have any active enrollment slots available?

"Clinicaltrials.gov presently displays this clinical trial's details, which were first published on December 5th 2022 and recently modified on November 29th of the same year."

Answered by AI

Is Stereotactic Body Radiation Therapy (SBRT) sanctioned by the FDA?

"There is some evidence suggesting Stereotactic Body Radiation Therapy (SBRT) may be safe, so it received a rating of 2. However, there are no studies to attest its efficacy as this trial is still in Phase 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy

2023. "T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361798.

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