RECRUITING

A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer

Conditions

Prostate Cancer 2141-V11 Memorial Sloan Kettering Cancer Center 23-352

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment.

Official Title

Phase II Study Evaluating the Effects of Single Site Intratumoral Injections of Anti-CD40 Agonist Antibody (2141-V11) Given as Monotherapy Prior to Radical Prostatectomy to Men With Intermediate Risk Disease and in Combination With Androgen Deprivation Therapy for Those With High Risk Localized and Low Volume Metastatic Disease

Quick Facts

Study Start:2024-03-28

Study Completion:2029-03-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06347705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately * Male aged 18 years and above * Serum testosterone of ≥150 ng/dL (Cohorts B and C) except for patients currently on ADT. * Adequate bone marrow, hepatic, and renal function, as evidenced within 28 days prior to treatment start by: * Participants must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the 8th edition American Joint Committee on Cancer (AJCC) staging system, recorded as the urologist's/medical oncologist's best clinical assessment of extent of local disease by digital rectal examination and/or available imaging studies such as transrectal ultrasound, CT scan, and/or MRI. (Applicable to Cohorts A, B and C). * Candidate for RP with lymph node dissection as per the investigator * Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug. * Evidence of a targetable prostate lesion on prostate magnetic resonance imaging scan	* Prior prostate surgery, pelvic lymph node dissection, radiation therapy, or focal therapy as a treatment for prostate cancer or benign prostatic disease. * Current ADT with GnRH antagonist/agonist and/or ARSI initiated \>8 weeks prior to planned Cycle 1 of 2141-V11. * Prior cytotoxic chemotherapy for prostate cancer * Prior experimental therapy for prostate cancer within 30 days of planned Cycle 1 of 2141-V11. * Known brain, liver, lung or other visceral metastasis (with the exception of retroperitoneal and / or pelvic nodal metastases as per inclusion criteria) * Prior prostate cancer metastasis-directed therapies other than described above. * Currently active second malignancy or past medical history of malignancies diagnosed within the last 5 years that require active therapy and/or in remission with life expectancy of \< 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer. * Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to: * Any medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone once daily * Active infection requiring systemic therapy * History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents * Uncontrolled hypertension (systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment (systolic BP \<160 mmHg or diastolic BP \<95 mmHg) * Acute or chronic hepatitis B or hepatitis C infection. (Hepatitis B and C testing are not mandatory) * Presence of hepatitis B surface antibody is acceptable * Baseline moderate and severe hepatic impairment (Child Pugh Class B \& C) * Human immunodeficiency virus (HIV)-positive participants with 1 or more of the following: * Not receiving highly active anti-retroviral therapy. * A change in anti-retroviral therapy within 6 months of the start of screening (except if, after consultation with the principal investigator (PI) / sponsor, a change is made to avoid a potential drug-drug interaction with the study drug). * Receiving anti-retroviral therapy that may interfere with the study drug(s) (consult the PI / sponsor for review of medication prior to enrollment). * CD4 count \< 350 cell/mm3 at screening. * An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening. * HIV testing is not mandatory * History of pituitary or adrenal dysfunction * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline, or clinically significant ventricular arrhythmias within 6 months prior to treatment start. * History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness * History of an inflammatory bowel disease (Crohn's or ulcerative colitis) * Any additional medications that investigators are concerned will affect the response to immunotherapy. * Use of any prohibited concomitant medications precluding safe treatment with ADT or an ARSI within 14 days prior to treatment start. * Known allergies, hypersensitivity or intolerance to apalutamide, enzalutamide, daralutamide or GNRH agonist or GNRH antagonist * Participants that cannot tolerate MRI

Inclusion Criteria

Exclusion Criteria

* Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
* Male aged 18 years and above
* Serum testosterone of ≥150 ng/dL (Cohorts B and C) except for patients currently on ADT.
* Adequate bone marrow, hepatic, and renal function, as evidenced within 28 days prior to treatment start by:
* Participants must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the 8th edition American Joint Committee on Cancer (AJCC) staging system, recorded as the urologist's/medical oncologist's best clinical assessment of extent of local disease by digital rectal examination and/or available imaging studies such as transrectal ultrasound, CT scan, and/or MRI. (Applicable to Cohorts A, B and C).
* Candidate for RP with lymph node dissection as per the investigator
* Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
* Evidence of a targetable prostate lesion on prostate magnetic resonance imaging scan

* Prior prostate surgery, pelvic lymph node dissection, radiation therapy, or focal therapy as a treatment for prostate cancer or benign prostatic disease.
* Current ADT with GnRH antagonist/agonist and/or ARSI initiated \>8 weeks prior to planned Cycle 1 of 2141-V11.
* Prior cytotoxic chemotherapy for prostate cancer
* Prior experimental therapy for prostate cancer within 30 days of planned Cycle 1 of 2141-V11.
* Known brain, liver, lung or other visceral metastasis (with the exception of retroperitoneal and / or pelvic nodal metastases as per inclusion criteria)
* Prior prostate cancer metastasis-directed therapies other than described above.
* Currently active second malignancy or past medical history of malignancies diagnosed within the last 5 years that require active therapy and/or in remission with life expectancy of \< 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer.
* Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:
* Any medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone once daily
* Active infection requiring systemic therapy
* History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
* Uncontrolled hypertension (systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment (systolic BP \<160 mmHg or diastolic BP \<95 mmHg)
* Acute or chronic hepatitis B or hepatitis C infection. (Hepatitis B and C testing are not mandatory)
* Presence of hepatitis B surface antibody is acceptable
* Baseline moderate and severe hepatic impairment (Child Pugh Class B \& C)
* Human immunodeficiency virus (HIV)-positive participants with 1 or more of the following:
* Not receiving highly active anti-retroviral therapy.
* A change in anti-retroviral therapy within 6 months of the start of screening (except if, after consultation with the principal investigator (PI) / sponsor, a change is made to avoid a potential drug-drug interaction with the study drug).
* Receiving anti-retroviral therapy that may interfere with the study drug(s) (consult the PI / sponsor for review of medication prior to enrollment).
* CD4 count \< 350 cell/mm3 at screening.
* An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
* HIV testing is not mandatory
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline, or clinically significant ventricular arrhythmias within 6 months prior to treatment start.
* History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness
* History of an inflammatory bowel disease (Crohn's or ulcerative colitis)
* Any additional medications that investigators are concerned will affect the response to immunotherapy.
* Use of any prohibited concomitant medications precluding safe treatment with ADT or an ARSI within 14 days prior to treatment start.
* Known allergies, hypersensitivity or intolerance to apalutamide, enzalutamide, daralutamide or GNRH agonist or GNRH antagonist
* Participants that cannot tolerate MRI

Contacts and Locations

Study Contact

Matthew Dallos, MD

CONTACT

646-888-4716

dallosm@mskcc.org

Howard Scher, MD

CONTACT

646-888-4208

scherh@MSKCC.ORG

Principal Investigator

Matthew Dallos, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Matthew Dallos, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28

Study Completion Date2029-03-28

Study Record Updates

Study Start Date2024-03-28

Study Completion Date2029-03-28

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer
2141-V11
Memorial Sloan Kettering Cancer Center
23-352

Additional Relevant MeSH Terms

Prostate Cancer