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Castration-Resistant Prostatic NeoplasmsPhase 1NCT03551782

A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 study testing Cetrelimab 480 mg and Apalutamide 240 mg in people with Castration-Resistant Prostatic Neoplasms, run by Janssen Research & Development, LLC at 34 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-Resistant Prostatic Neoplasms
What is being tested?
Cetrelimab 480 mg and Apalutamide 240 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
34 sitesin 7 countries
Study dates
28 Jun 2018to 11 Nov 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

34 sites in 7 countries.

34 sites in 7 countries

United States11 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5000

  • Centers for Advanced Urology, LLC; d/b/a MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Washington University

    Bay Saint Louis, Mississippi, 63110

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • New York University Langone Medical Center

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

    New York, New York, 10029-6542

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of California San Francisco (UCSF) - Prostate Cancer Center

    San Francisco, California, 94158-2350

  • Regional Urology LLC

    Shreveport, Louisiana, 71106

Other trials in United States

Spain9 sites

  • Hosp. Univ. Vall D Hebron

    Barcelona, 8035

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28009

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. Hm Sanchinarro

    Madrid, 28050

  • Hosp. Virgen de La Victoria

    Málaga, 29010

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Russia5 sites

  • Moscow City Clinical Hospital # 62

    Moscow, 125130

  • Hertzen Oncology Research Institute

    Moscow, 125284

  • Clinical Oncology Dispensary

    Omsk, 644013

  • Non-State Healthcare Institution 'Road Clinical Hospital of Russian Railways'

    Saint Petersburg, 195271

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, 197758

Other trials in Russia

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0A9

  • University of Toronto

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Netherlands3 sites

  • NKI-AVL, Amsterdam

    Amsterdam, 1066 CX

  • UMC Radboud

    Nijmegen, 6525AG

  • Sint Franciscus Gasthuis

    Rotterdam, 3045 PM

Other trials in Netherlands

Belgium2 sites

  • Grand Hôpital de Charleroi, site Notre Dame

    Charleroi, 6000

  • AZ Maria Middelares

    Ghent, 9000

Other trials in Belgium

Italy1 site

  • Istituto Europeo di Oncologia Servizio Radioterapia

    Milan, 20141

Other trials in Italy

About this study

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

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.

Read the detailed description

This study is of participants originally diagnosed with adenocarcinoma of the prostate who have now developed mCRPC and who have progressed on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), apalutamide, darolutamide, or enzalutamide. Participants with treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) assessed by the screening biopsy may be considered for this study. Participants must have confirmed prostate-specific antigen (PSA) progression per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria. The primary hypothesis is that treatment with cetrelimab and apalutamide is safe and leads to improvement in the 12-week PSA response rate. The study consists of an Optional Pre-screening Period, Screening period (28 days prior to Cycle 1 Day 1), Treatment Period, End-of-Treatment Visit (performed after the last dose of study drug is administered), and Follow-up Period (participants will have Follow-up assessment every 12 weeks after the End-of-Treatment Visit). The efficacy, safety, and pharmacokinetics of cetrelimab in combination with apalutamide will be evaluated.

Being tested
Cetrelimab 480 mg, Apalutamide 240 mg
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cetrelimab 480 mgDrug

    Also called JNJ-63723283

    Cetrelimab 480 mg will be administered intravenously (IV) on Cycle 1 Day 1, then every 4 weeks thereafter (Q4W).

  • Apalutamide 240 mgDrug

    Also called JNJ-56021927

    Apalutamide 240 mg (4*60 mg) tablets per day will be administered orally.

Study groups in NCT03551782
Study groupRoleWhat they receive
Cohort 1ExperimentalBiomarker-negative or biomarker-unknown participants with adenocarcinoma (and not treatment-emergent small-cell neuroendocrine prostate cancer [t-SCNC]) who progressed on abiraterone acetate plus prednisone/prednisolone (AA-P) will be enrolled in this cohort. Participants will receive cetrelimab 480 milligram (mg) plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Receives: Drug: Cetrelimab 480 mg; Drug: Apalutamide 240 mg
Cohort 2ExperimentalBiomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1.
Receives: Drug: Cetrelimab 480 mg; Drug: Apalutamide 240 mg
Cohort 3ExperimentalBiomarker-positive participants who progressed on AA-P will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Receives: Drug: Cetrelimab 480 mg; Drug: Apalutamide 240 mg
Cohort 4ExperimentalBiomarker-positive participants who progressed on apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Receives: Drug: Cetrelimab 480 mg; Drug: Apalutamide 240 mg
Cohort 5ExperimentalBiomarker-negative participants with t-SCNC who progressed on treatment with AA-P, apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Receives: Drug: Cetrelimab 480 mg; Drug: Apalutamide 240 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 2 years

  2. 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.

    Measured: Approximately 2 years

  3. 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.

    Measured: Week 12

Secondary outcomes (2)

  1. Maximal PSA Decline

    Maximal PSA decline is defined as maximal percent decrease in PSA at any time during treatment.

    Measured: Approximately 2 years

  2. 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.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start28 Jun 2018
  3. Primary completion11 Nov 2021
  4. Study completion11 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551782
Sponsor's protocol ID
CR108476
Other IDs
2018-000182-37, 56021927PCR2032, 2018
Status last verified
Feb 2022
First submitted
30 May 2018
Last updated
25 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cetrelimab 480 mg and Apalutamide 240 mg in people with Castration-Resistant Prostatic Neoplasms, run by Janssen Research & Development, LLC at 34 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Spain, Russia, Canada, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03551782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.

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