Castration-Resistant Prostatic Neoplasms Clinical Trial
Official title:
An Open-label, Multicenter, Phase 1b Study of JNJ-63723283, a PD-1 Inhibitor, Administered in Combination With Apalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer
| Verified date | February 2022 |
| Source | Janssen Research & Development, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety of the combination of cetrelimab, with apalutamide and to define a population of participants with metastatic castration-resistant prostate cancer (mCRPC) who respond to treatment with the combination of cetrelimab and apalutamide.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | November 11, 2021 |
| Est. primary completion date | November 11, 2021 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Pathologically confirmed adenocarcinoma of the prostate. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) on screening biopsy may be eligible for cohort 5 - Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of positron emission tomography (PET)/CT scan may be used for eligibility. If lymph node metastasis is the only evidence of metastatic disease, it must be greater than (>=) 1.0 centimeter (cm) in the short axis and above the level of the iliac bifurcation - Progressed while on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), enzalutamide, darolutamide, or apalutamide for mCRPC. No washout is required and no additional therapy may have been administered between discontinuation of AR-targeted the agent and study treatment. Participants will be assigned to cohorts based on the results of the biomarker panel. Cohort 1: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on abiraterone acetate plus prednisone/prednisolone (AA-P); Cohort 2: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 3: Biomarker-positive participants who progressed on AA-P; Cohort 4: Biomarker-positive participants who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 5: Biomarker-negative participants with t-SCNC who progressed on treatment with AA-P, apalutamide, darolutamide, or enzalutamide - Surgical or medical castration, with testosterone levels of less than (<)50 nanogram per deciliter (ng/dL). If the participant is being treated with gonadotropin-releasing hormone (GnRH) analogs (participant who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 4 weeks prior to first dose of study drug and must be continued throughout the study - Eastern Cooperative Oncology Group Performance Status (ECOG) prostate-specific (PS) grade of 0 or 1 Exclusion Criteria: - Initial diagnosis of primary prostatic neuroendocrine or small cell carcinoma - Brain metastases - Prior treatment with an anti-programmed cell death receptor-1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody - Prior chemotherapy, except for docetaxel for hormone-sensitive prostate cancer (HSPC) - Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Grand Hôpital de Charleroi, site Notre Dame | Charleroi | |
| Belgium | AZ Maria Middelares | Gent | |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Centre de Recherche du CHUM | Montreal | Quebec |
| Canada | University of Toronto | Toronto | Ontario |
| Italy | Istituto Europeo di Oncologia Servizio Radioterapia | Milano | |
| Netherlands | NKI-AVL, Amsterdam | Amsterdam | |
| Netherlands | UMC Radboud | Nijmegen | |
| Netherlands | Sint Franciscus Gasthuis | Rotterdam | |
| Russian Federation | Hertzen Oncology Research Institute | Moscow | |
| Russian Federation | Moscow City Clinical Hospital # 62 | Moscow | |
| Russian Federation | Clinical Oncology Dispensary | Omsk | |
| Russian Federation | Non-State Healthcare Institution 'Road Clinical Hospital of Russian Railways' | Saint Petersburg | |
| Russian Federation | Russian Scientific Center of Radiology and Surgical Technologies | Sankt-Peterburg | |
| Spain | Hosp. Univ. Vall D Hebron | Barcelona | |
| Spain | Hosp. Gral. Univ. Gregorio Marañon | Madrid | |
| Spain | Hosp. Univ. Fund. Jimenez Diaz | Madrid | |
| Spain | Hosp. Univ. Hm Sanchinarro | Madrid | |
| Spain | Hosp. Univ. Ramon Y Cajal | Madrid | |
| Spain | Hosp. Virgen de La Victoria | Málaga | |
| Spain | Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcon | |
| Spain | Hosp. Univ. Marques de Valdecilla | Santander | |
| Spain | Instituto Valenciano de Oncologia | Valencia | |
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| United States | Centers for Advanced Urology, LLC; d/b/a MidLantic Urology | Bala-Cynwyd | Pennsylvania |
| United States | Washington University | Bay Saint Louis | Mississippi |
| United States | Levine Cancer Institute, Carolinas HealthCare System | Charlotte | North Carolina |
| United States | University of Texas, MD Anderson Cancer Center | Houston | Texas |
| United States | Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg | New York | New York |
| United States | New York University Langone Medical Center | New York | New York |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | University of California San Francisco (UCSF) - Prostate Cancer Center | San Francisco | California |
| United States | Regional Urology LLC | Shreveport | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Research & Development, LLC |
United States, Belgium, Canada, Italy, Netherlands, Russian Federation, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Approximately 2 years | |
| Primary | Number of Participants with AEs by Severity | Severity of AEs will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Any AE not listed in the NCI CTCAE will be graded according to the investigator clinical judgment by using the standard grades as follows: Grade 1 Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 Moderate: Sufficient discomfort is present to cause interference with normal activity; Grade 3 Severe: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to the AE. | Approximately 2 years | |
| Primary | Percentage of Participants with Prostate-Specific Antigen (PSA) Response at Week 12 | Percentage of participants with baseline in PSA level response (greater than or equal to [>=]50 percent [%] decrease from baseline in PSA) will be reported at Week 12. | Week 12 | |
| Secondary | Maximal PSA Decline | Maximal PSA decline is defined as maximal percent decrease in PSA at any time during treatment. | Approximately 2 years | |
| Secondary | Percentage of Participants with Circulating Tumor Cell (CTC) Response | Percentage of participants with CTC response (either CTC less than [<]5 cells/7.5 milliliter [mL] with CTC >=5 at baseline or CTC = 0 cells/7.5 mL with CTC >=1 at baseline) will be reported. | Approximately 2 years |