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

NCT05960578 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1123487NCI-2023-04887FHIRB0020135
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Prostate specific antigen (PSA)50 response rate

  Defined by at least a 50% decline in PSA from baseline, in subjects with castrate resistant prostate cancer after combination treatment with TNF-alpha alpha blockade (golimumab) and AR antagonism (apalutamide).

  Up to 12 weeks

Secondary Outcomes (6)

• Objective response rate

  Up to 4 years

• Radiographic progression free survival (PFS)

  Up to 4 years

• PSA PFS

  Up to 4 years

• PSA Doubling Time

  Up to 4 years

• Time to subsequent antineoplastic therapy

  Up to 4 years

Study Arms (1)

Treatment (golimumab, apalutamide)

EXPERIMENTAL

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.

Drug: Apalutamide; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Golimumab; Procedure: Magnetic Resonance Imaging; Procedure: PSMA PET Scan; Procedure: Bone Scan

Interventions

Apalutamide DRUG

Given PO

Also known as: ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927

Treatment (golimumab, apalutamide)

Biopsy PROCEDURE

Undergo tumor biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (golimumab, apalutamide)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (golimumab, apalutamide)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (golimumab, apalutamide)

Golimumab DRUG

Given SC

Also known as: CNTO 148, Immunoglobulin G1, Anti-(Human Tumor Necrosis Factor Alpha) (Human Monoclonal CNTO 148 Gamma-1-Chain), Disulfide with Human Monoclonal CNTO 148 Kappa-Chain, Dimer

Treatment (golimumab, apalutamide)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Treatment (golimumab, apalutamide)

PSMA PET Scan PROCEDURE

Undergo PSMA PET

Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Treatment (golimumab, apalutamide)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Treatment (golimumab, apalutamide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: collaborator
• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Biopsy; Specimen Handling; golimumab; Immunoglobulin G; Disulfides; Magnetic Resonance Spectroscopy; Glutamate Carboxypeptidase II

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Carboxypeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• Ruben Raychaudhuri, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: May 23, 2024
• Primary Completion: July 29, 2025
• Study Completion (Estimated): April 14, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)