A Phase 2 interventional study of Apalutamide and GnRH Agonist in Salivary Gland Neoplasms, sponsored by Janssen Pharmaceutical K.K.. Active, not recruiting at 7 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Janssen Pharmaceutical K.K. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate the overall response rate (ORR) of apalutamide in combination with a gonadotropin-releasing hormone (GnRH) agonist in participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC).
242 studies on the registry are indexed under Salivary Gland Neoplasms; 29 are open to participants now.
This study's enrollment of 31 is below the median of 37 across 175 interventional studies indexed under Salivary Gland Neoplasms.
Browse Salivary Gland Neoplasms studies →Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive apalutamide 240 milligram (mg) in combination with a gonadotropin-releasing hormone (GnRH) agonist until disease progression, unacceptable toxicity, death, or the end of the study and each treatment cycle will be of 28 days. Participants who are benefitting from this study will enter long term extension phase.
Drug: Apalutamide · Drug: GnRH Agonist
Apalutamide 240 mg (4\*60-mg tablets) will be administered orally once daily with or without food.
Also known as: JNJ-56021927
A stable regimen of goserelin 3.6 mg will be administered as a GnRH agonist.
Overall Response Rate (ORR)
Overall response rate (ORR) was defined as the percentage of participants who achieve partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version1.1, including with either confirmed best overall response of complete response (CR) or PR during the study. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
Time frame: Up to 13 months
Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR) was defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or stable disease (SD) for at least 24 weeks based on RECIST version 1.1 during the study (and prior to subsequent therapy if any). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 13 months
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or SD based on RECIST version 1.1 during the study (and prior to subsequent therapy if any). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
Time frame: Up to 13 months
Progression-free Survival (PFS) as Assessed by ICRR
PFS was defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time frame: Up to 13 months
Overall Survival (OS)
Overall survival (OS) was defined as the time from the date of the initial dose of study intervention to the date of the participant's death.
Time frame: Up to 13 months
Time to Response (TTR)
TTR was defined among responders (with a CR or PR) as the time between date of the initial dose of study intervention and the first efficacy evaluation that the participant had met all criteria for CR or PR. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
Time frame: Up to 13 months
Duration of Response (DoR)
DoR calculated among responders from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease as defined in RECIST version 1.1 or death, whichever occurred first. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
Time frame: Up to 13 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. Treatment-emergent adverse events (TEAEs) for the treatment phase included events with an onset date/time on or after the start of study intervention through the day of last dose plus 30 days were considered as treatment-emergent.
Time frame: Up to 13 months
Plasma Concentration of Apalutamide
Plasma concentration of apalutamide was reported.
Time frame: Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)
Plasma Concentration of N-desmethyl Apalutamide
Plasma concentration of N-desmethyl Apalutamide was reported.
Time frame: Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)
| Milestone | Apalutamide + Goserelin |
|---|---|
| Started | 31 |
| Completed | 5 |
| Not completed | 26 |
| Withdrew: Ongoing | 26 |
Overall response rate (ORR) was defined as the percentage of participants who achieve partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version1.1, including with either confirmed best overall response of complete response (CR) or PR during the study. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR is defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
| percentage of participants | Apalutamide + Goserelin |
|---|---|
| Overall Response Rate (ORR) | 25 |
Clinical benefit rate (CBR) was defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or stable disease (SD) for at least 24 weeks based on RECIST version 1.1 during the study (and prior to subsequent therapy if any). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
| percentage of participants | Apalutamide + Goserelin |
|---|---|
| Clinical Benefit Rate (CBR) | 50 |
DCR was defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or SD based on RECIST version 1.1 during the study (and prior to subsequent therapy if any). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.
| percentage of participants | Apalutamide + Goserelin |
|---|---|
| Disease Control Rate (DCR) | 70.8 |
PFS was defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
| months | Apalutamide + Goserelin |
|---|---|
| Progression-free Survival (PFS) as Assessed by ICRR | 7.43 (3.65 to NA) |
Overall survival (OS) was defined as the time from the date of the initial dose of study intervention to the date of the participant's death.
| months | Apalutamide + Goserelin |
|---|---|
| Overall Survival (OS) | NA (NA to NA) |
TTR was defined among responders (with a CR or PR) as the time between date of the initial dose of study intervention and the first efficacy evaluation that the participant had met all criteria for CR or PR. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
| months | Apalutamide + Goserelin |
|---|---|
| Time to Response (TTR) | 1.87 (1.7 to 3.7) |
DoR calculated among responders from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease as defined in RECIST version 1.1 or death, whichever occurred first. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, in absence of new lesions or unequivocal progression of non-target lesions.
| months | Apalutamide + Goserelin |
|---|---|
| Duration of Response (DoR) | NA (6.64 to NA) |
Number of participants with TEAEs were reported. Treatment-emergent adverse events (TEAEs) for the treatment phase included events with an onset date/time on or after the start of study intervention through the day of last dose plus 30 days were considered as treatment-emergent.
| Participants | Apalutamide + Goserelin |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 28 |
Plasma concentration of apalutamide was reported.
| micrograms per milliliter (mcg/mL) | Apalutamide + Goserelin |
|---|---|
| Cycle 02 Day 1, Predose | 4.67 ± 1.19 |
| Cycle 03 Day 1, Predose | 4.32 ± 1.35 |
| Cycle 04 Day 1, Predose | 4.05 ± 1.46 |
| Cycle 05 Day 1, Predose | 4.18 ± 1.38 |
| Cycle 06 Day 1, Predose | 4.16 ± 1.52 |
Plasma concentration of N-desmethyl Apalutamide was reported.
| mcg/mL | Apalutamide + Goserelin |
|---|---|
| Cycle 02 Day 1, Predose | 7.19 ± 1.21 |
| Cycle 03 Day 1, Predose | 6.89 ± 1.56 |
| Cycle 04 Day 1, Predose | 6.29 ± 1.66 |
| Cycle 05 Day 1, Predose | 6.53 ± 1.81 |
| Cycle 06 Day 1, Predose | 6.40 ± 1.91 |
Collected over Up to 13 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apalutamide + Goserelin | 4/31 (12.9%) | 5/31 (16.1%) | 28/31 (90.3%) |
| Event | Apalutamide + Goserelin |
|---|---|
| Cancer PainNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/31 |
| AnaemiaBlood and lymphatic system disorders | 1/31 |
| Oesophageal StenosisGastrointestinal disorders | 1/31 |
| Cerebral InfarctionNervous system disorders | 1/31 |
| HydronephrosisRenal and urinary disorders | 1/31 |
| Laryngeal OedemaRespiratory, thoracic and mediastinal disorders | 1/31 |
| Event | Apalutamide + Goserelin |
|---|---|
| Rash Maculo-PapularSkin and subcutaneous tissue disorders | 10/31 |
| RashSkin and subcutaneous tissue disorders | 8/31 |
| HypothyroidismEndocrine disorders | 6/31 |
| Hot FlushVascular disorders | 6/31 |
| MalaiseGeneral disorders | 5/31 |
| MyalgiaMusculoskeletal and connective tissue disorders | 5/31 |
| InsomniaPsychiatric disorders | 5/31 |
| AnaemiaBlood and lymphatic system disorders | 4/31 |
| NauseaGastrointestinal disorders | 4/31 |
| Weight DecreasedInvestigations | 4/31 |
| Age, Continuous(years) | Apalutamide + Goserelin |
|---|---|
| Median | 65 (50 to 84) |
| Sex: Female, Male(Participants) | Apalutamide + Goserelin |
|---|---|
| Female | 1 |
| Male | 30 |
| Ethnicity (NIH/OMB)(Participants) | Apalutamide + Goserelin |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 31 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Apalutamide + Goserelin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 31 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.janssen.com
Ran from Apr 2020 to primary completion in Jun 2021, 14 months.
Results were first posted in Jul 2022, 1 year after primary completion.
Of 45 phase 2 interventional studies under Salivary Gland Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 94. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Apalutamide · Gonadotropin-releasing Hormone Analog