Trial Title:
Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study
NCT ID:
NCT05960578
Condition:
Castration-Resistant Prostate Carcinoma
Prostate Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Prostatic Neoplasms
Golimumab
Immunoglobulins
Immunoglobulin G
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide
Description:
Given PO
Arm group label:
Treatment (golimumab, apalutamide)
Other name:
ARN 509
Other name:
ARN-509
Other name:
ARN509
Other name:
Erleada
Other name:
JNJ 56021927
Other name:
JNJ-56021927
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo tumor biopsy
Arm group label:
Treatment (golimumab, apalutamide)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (golimumab, apalutamide)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (golimumab, apalutamide)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Golimumab
Description:
Given SC
Arm group label:
Treatment (golimumab, apalutamide)
Other name:
CNTO 148
Other name:
Immunoglobulin G1, Anti-(Human Tumor Necrosis Factor Alpha) (Human Monoclonal CNTO 148 Gamma-1-Chain), Disulfide with Human Monoclonal CNTO 148 Kappa-Chain, Dimer
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (golimumab, apalutamide)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
PSMA PET Scan
Description:
Undergo PSMA PET
Arm group label:
Treatment (golimumab, apalutamide)
Other name:
Prostate-specific Membrane Antigen PET
Other name:
PSMA PET
Other name:
PSMA-Positron emission tomography
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 apalutaminde 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), and collection of blood samples at baseline, during cycle 4, and at end
of treatment.
After completion of study treatment, patients are followed every 3 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- History of histologically diagnosed prostatic adenocarcinoma
- Participants must have evidence of castration resistant prostate cancer as evidenced
by a confirmed rising prostate specific antigen (PSA) or radiographic progression
(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)
- Participants must have been treated with at least 6 months of novel hormonal therapy
(NHT) in the hormone-sensitive setting including but not limited to either
abiraterone, enzalutamide, darolutamide, or apalutamide. (Biosimilar or generic
agents may be allowed at the discretion of the principal investigator [PI])
- Participants demonstrate disease progression with two successive PSA rises above the
nadir on the last prior therapy or most recent time interval, separated by >= 1
week, with the last determination having a value of ≥ 2 ng/mL, or evidence of
radiographic disease progression on NHT prior to enrollment.
- Participants may have received prior chemotherapy in the hormone-sensitive setting
so long as >= 6 months prior to enrollment. (Prior chemotherapy in the CRPC setting
is not allowed)
- 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 no signs or symptoms suggestive of active tuberculosis (TB) upon medical
history and/or physical examination
- Have had no known recent close contact with a person with active TB or, if there has
been such contact, will be referred to a physician specializing in TB to undergo
additional evaluation
- Within 42 days before the first administration of study intervention, have a
negative QuantiFERON-TB test result
- Have a chest radiograph (both posterior-anterior and lateral views, or per country
regulations where applicable), taken within 12 weeks before the first administration
of study intervention and read by a radiologist or qualified pulmonologist, with no
evidence of current, active TB or old, inactive TB. A chest computed tomography scan
is also acceptable if already available or obtained outside of the study protocol
- 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 who have had chemotherapy in the CRPC setting
- Subjects who have received > 6 weeks of NHT in CRPC setting
- 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
- Symptomatic central nervous system (CNS) metastases. Treated CNS metastases will be
allowed if these are stable for at least 8 weeks prior to enrollment
- Hepatitis B infection (acute and chronic) as defined according to the American
Society of Clinical Oncology guidelines. In the event the infection status is
unclear, quantitative levels are necessary to determine the infection status.
Hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-ribonucleic acid
[RNA] quantitation positive) or known to have a history of hepatitis C. If positive,
further testing of quantitative levels to rule out positivity is required
- Has impaired wound healing capacity defined as 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)
- Uncontrolled or concurrent illness including within the past 6 months, but not
limited to, ongoing or active infection, history or ongoing chronic or recurrent
infectious diseases, or any immune deficiency syndromes, severe or unstable angina,
myocardial infarction, congestive heart failure (asymptomatic or symptomatic),
uncontrolled hypertension, clinically significant arterial or venous thromboembolic
events (e.g., pulmonary embolism, cerebrovascular accident including transient
ischemic attacks), or clinically significant ventricular arrhythmias or New York
Heart Association Class II to IV heart disease, or psychiatric illness/social
situations that would limit compliance with study requirements
- 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
- History of active or latent TB prior to screening or evidence of active or latent TB
during screening
- History or ongoing chronic or recurrent infectious diseases, or any immune
deficiency syndromes
- Concomitant diagnosis or history of congestive heart failure (CHF), including
medically controlled asymptomatic CHF
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg,
unstable angina, rapid atrial fibrillation, or transient ischemic attack) in the
last 3 months prior to screening or a cardiac hospitalization within the last 3
months prior to screening
- History of a demyelinating disorder such as 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 5 years before
screening (with the exception of prostate 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
- Has a history of lymphoproliferative disease, including lymphoma; a history of
monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive
of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Has or has had a herpes zoster infection within 2 months before screening
- Have had a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis), have
been hospitalized for an infection, or have been treated with parenteral antibiotics
for an infection within 2 months prior to first administration of study drug. 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
- Immune deficiency syndrome (e.g., severe combined immunodeficiency syndrome [SCIDS],
T cell deficiency syndromes, B cell deficiency syndromes, and chronic granulomatous
disease)
- Are known to be infected with HIV (HIV antibody positive)
- Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
- Note: Patients must agree not to receive a Bacillus Calmette-Guerin (BCG)
vaccination during the study, and within 16 weeks after the last administration
of study intervention
- Has ever had a nontuberculous mycobacterial infection or opportunistic infection
(eg, cytomegalovirus, pneumocystis jirovecii, aspergillosis)
- Has a history of active granulomatous infection, including histoplasmosis, or
coccidioidomycosis, before screening
- Have signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematologic, endocrine, pulmonary, cardiac, vascular, GI, rheumatologic, neurologic,
psychiatric, or cerebral diseases
- Suicidal ideation
- Has a history of an infected joint prosthesis or has ever received antibiotics for a
suspected infection of a joint prosthesis, if that prosthesis has not been removed
or replaced
- Known allergies, hypersensitivity, or intolerance to apalutamide or its excipients
- Uncontrolled hypertension
- Gastrointestinal disorder affecting absorption
- Seizure or known condition that may pre-dispose to seizure (e.g., prior stroke
within 1 year to randomization, brain arteriovenous malformation, Schwannoma,
meningioma, or other benign central nervous system (CNS) or meningeal disease which
may require treatment with surgery or radiation therapy)
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Hawley
Phone:
206-606-1943
Email:
jehawley@uw.edu
Investigator:
Last name:
Jessica Hawley
Email:
Principal Investigator
Start date:
May 23, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
Janssen Scientific Affairs, LLC
Agency class:
Industry
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05960578
