Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study

NCT ID: NCT05960578

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2027-12-31

Brief Summary

This phase II trial tests how well golimumab and apalutamide work in treating patients with castration resistant prostate cancer. Golimumab is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving golimumab and apalutamide may work better in treating patients with castration-resistant prostate cancer.

Detailed Description

OUTLINE:

Patients receive golimumab subcutaneously (SC) every 4 weeks for 6 doses and apalutamide orally (PO) daily. Treatment with apalutamide continues in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy at baseline and during cycle 4. Patients also undergo computed tomography (CT) scans or magnetic resonance imaging (MRI), prostate-specific membrane antigen (PSMA) positron emission tomography (PET), bone scan, and collection of blood samples throughout the study.

After completion of study treatment, patients are followed every 3 months.

Conditions

Metastatic Castration-Resistant Prostate Carcinoma; Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (golimumab, apalutamide)

Patients receive golimumab SC every 4 weeks for 6 doses and apalutamide PO daily. Treatment with apalutamide continues in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy at baseline and during cycle 4. Patients also undergo CT scans or MRI, PSMA PET, bone scan, and collection of blood samples throughout the study.

Group Type: EXPERIMENTAL

Apalutamide

Intervention Type: DRUG

Given PO

Biopsy

Intervention Type: PROCEDURE

Undergo tumor biopsy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood samples

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT scan

Golimumab

Intervention Type: DRUG

Given SC

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

PSMA PET Scan

Intervention Type: PROCEDURE

Undergo PSMA PET

Bone Scan

Intervention Type: PROCEDURE

Undergo bone scan

Interventions

Apalutamide

Given PO

Intervention Type: DRUG

Biopsy

Undergo tumor biopsy

Intervention Type: PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

Intervention Type: PROCEDURE

Computed Tomography

Undergo CT scan

Intervention Type: PROCEDURE

Golimumab

Given SC

Intervention Type: DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

PSMA PET Scan

Undergo PSMA PET

Intervention Type: PROCEDURE

Bone Scan

Undergo bone scan

Intervention Type: PROCEDURE

Other Intervention Names

Immunoglobulin G1, Anti-(Human Tumor Necrosis Factor Alpha) (Human Monoclonal CNTO 148 Gamma-1-Chain), Disulfide with Human Monoclonal CNTO 148 Kappa-Chain, Dimer; Magnetic Resonance; Magnetic resonance imaging (procedure); Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Prostate-specific Membrane Antigen PET; PSMA PET; PSMA-Positron emission tomography; Bone Scintigraphy; ARN 509; ARN-509; ARN509; Erleada; JNJ 56021927; JNJ-56021927; BIOPSY_TYPE; Bx; Biological Sample Collection; Biospecimen Collected; Specimen Collection; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized axial tomography (procedure); Computerized Tomography; CT; CT Scan; tomography; CNTO 148

Eligibility Criteria

Inclusion Criteria

• History of histologically diagnosed prostatic adenocarcinoma
• Participants must have progressed on no more than one novel hormonal therapy (NHT) by PSA or radiographic criteria (per Prostate Cancer Working Group 3 [PCWG3] or Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) and a castrate serum testosterone level (i.e., ≤ 50 ng/dL). If progressive disease by radiographic criteria, PSA must be ≥ 2ng/ml. PSA progression will be defined as at least two successive PSA rises above the nadir, separated by ≥ 1 week, with the last determination having a value of ≥ 2 ng/mL. NHTs include but are not limited to either abiraterone, enzalutamide, darolutamide, or apalutamide. (Biosimilar or generic agents may be allowed at the discretion of the principal investigator [PI].) Note: prior NHT exposure that did not result in disease progression will not be counted as prior line, i.e., patient's that completed prior abiraterone course in the localized setting, patients that changed NHT due to toxicity or financial toxicity
• Participants must have previously progressed on a novel hormonal therapy (NHT) by PSA or radiographic criteria (per PCWG3 or RECIST v1.1). NHTs include but are not limited to either abiraterone, enzalutamide, darolutamide, or apalutamide. (Biosimilar or generic agents may be allowed at the discretion of the principal investigator [PI].) Note: prior NHT exposure that did not result in disease progression will not be counted as prior line, i.e., patient's that completed prior abiraterone course in the localized setting, patients that changed NHT due to toxicity or financial toxicity
• Participants may have received one prior line of taxane chemotherapy in any setting
• Participants must be >= 18 years of age prior to signing informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status score =< 2
• Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
• Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
• Absolute neutrophil count >= 1.5 x 10^3/mL
• Serum albumin >= 3.0 g/dL
• Serum creatinine =< 1.5 mg/dL
• Serum potassium >= 3.5 mmol/L
• Serum total bilirubin < 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase =< 1.5 x ULN
• 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
• Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued or substituted at least 4 weeks prior to study entry
• Have had no known recent close contact with a person with active tuberculosis (TB) or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation
• Participants must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study

Exclusion Criteria

• Subjects may not be receiving other investigational agents within 14 days prior to enrollment
• Subjects with predominant small cell or neuroendocrine variant prostate cancer on most recent standard of care biopsy
• Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety
• Symptomatic central nervous system (CNS) metastases. Treated CNS metastases will be allowed if these are stable for at least 8 weeks prior to enrollment
• Uncontrolled or active infection, including:

• Hepatitis B infection (acute or chronic) as defined according to the American Society of Clinical Oncology guidelines, or hepatitis C infection (anti-hepatitis C virus [HCV] antibody positive and HCV-ribonucleic acid [RNA] quantitation positive)
• Recent serious infection (e.g., requiring IV antibiotics or hospitalization within last two months)
• Herpes zoster infection within 2 months of screening
• History of active granulomatous infection, including histoplasmosis, or coccidioidomycosis
• HIV (HIV antibody positive)
• Active or untreated latent tuberculosis
• History of infected joint prosthesis or received antibiotics for suspected infection of a joint prosthesis in the past five years, if that prosthesis has not been removed or replaced
• Less serious infections (e.g., acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator
• Has impaired wound healing capacity defined as current skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
• Major surgery within 2 weeks of the first dose, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration (Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate)
• Co-administration of other TNF-alpha inhibitors or disease-modifying anti-rheumatic drugs (DMARDS) for the treatment of rheumatoid arthritis or other rheumatologic condition. (Note: prior exposure to TNF-alpha inhibitors is allowed for non-rheumatologic disease (e.g., SARS-CoV-2) if washout period > 5 half-lives prior to study enrollment)
• Any other issue that would impair the ability of the subject to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Presence of significant cardiovascular disease including New York Heart Association (NYHA) class II-IV heart failure, uncontrolled arrhythmia, myocardial infarction (MI) or stroke within 6 months
• History of autoimmune disorder, including multiple sclerosis or optic neuritis, lupus or lupus-like Syndrome
• Hypersensitivity to any biologics or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAbs), or antibody fragments
• Have a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first administration of study drug)
• Currently has a malignancy or a history of malignancy within 3 years before screening (with the exception of prostate cancer, treated superficial bladder cancer, or a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months prior to the administration of the first study intervention
• Immune deficiency syndrome (e.g., severe combined immunodeficiency syndrome [SCIDS], T cell deficiency syndromes, B cell deficiency syndromes, and chronic granulomatous disease)
• Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening. Patients must agree not to receive BCG vaccination during the study and within 16 weeks after the last administration of study intervention
• Known allergies, hypersensitivity, or intolerance to apalutamide or its excipients
• Gastrointestinal disorder affecting absorption
• History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruben Raychaudhuri, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick Panlasigui

Role: CONTACT

ppanlas2@fredhutch.org

206-606-7486

Facility Contacts

Patrick Panlasigui

Role: primary

ppanlas2@fredhutch.org

206-606-7486

Other Identifiers

NCI-2023-04887

Identifier Type: REGISTRY

Identifier Source: secondary_id

FHIRB0020135

Identifier Type: OTHER

Identifier Source: secondary_id

RG1123487

Identifier Type: -

Identifier Source: org_study_id