Trial Outcomes & Findings for A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (NCT NCT04325828)

Last Updated: 2025-11-12

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Up to 13 months

Results posted on

2025-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Apalutamide + Goserelin Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Overall Study STARTED	31
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Apalutamide + Goserelin Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Overall Study Ongoing	26

Baseline Characteristics

A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apalutamide + Goserelin n=31 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Age, Continuous	65 years n=10 Participants
Sex: Female, Male Female	1 Participants n=10 Participants
Sex: Female, Male Male	30 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	31 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 13 months

Population: Response evaluable set included all participants who were androgen receptor (AR) positive by local test and were confirmed evaluable by independent central radiology review (ICRR) and also, who received at least 1 dose of study drug and had at least 1 postbaseline disease assessment or died due to disease progression before first postbaseline disease assessment. Here, 'N' (number of participants analyzed) included 24 response evaluable participants who were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=24 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Overall Response Rate (ORR)	25 percentage of participants

SECONDARY outcome

Timeframe: Up to 13 months

Population: Response evaluable set included all participants who were AR positive by local test and who were confirmed evaluable by an ICRR and also, all participants who received at least 1 dose of study intervention and who had at least 1 postbaseline disease assessment or died due to disease progression before the first postbaseline disease assessment. Here, 'N' (number of participants analyzed) included 24 response evaluable participants who were analyzed for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=24 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Clinical Benefit Rate (CBR)	50 percentage of participants

SECONDARY outcome

Timeframe: Up to 13 months

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.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=24 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Disease Control Rate (DCR)	70.8 percentage of participants

SECONDARY outcome

Timeframe: Up to 13 months

Population: Treated analysis set included all participants who received at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=31 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Progression-free Survival (PFS) as Assessed by ICRR	7.43 months Interval 3.65 to The upper limit of 95% confidence interval was not estimable due to less number of participants with events.

SECONDARY outcome

Timeframe: Up to 13 months

Population: Treated analysis set included all participants who received at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=31 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Overall Survival (OS)	NA months The median and 95% confidence interval were not estimable due to very less number of participants with events.

SECONDARY outcome

Timeframe: Up to 13 months

Population: Population analyzed included response evaluable set amongst who were responders (CR or PR).

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.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=6 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Time to Response (TTR)	1.87 months Interval 1.7 to 3.7

SECONDARY outcome

Timeframe: Up to 13 months

Population: Population analyzed included response evaluable set amongst who were responders (CR or PR).

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.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=6 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Duration of Response (DoR)	NA months Interval 6.64 to The median and upper limit of 95% confidence interval were not estimable due to very less number of participants with events.

SECONDARY outcome

Timeframe: Up to 13 months

Population: Safety analysis set included all participants who received at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=31 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	28 Participants

SECONDARY outcome

Timeframe: Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)

Population: Pharmacokinetics analysis set included all participants with at least 1 apalutamide and/or N-desmethyl apalutamide concentration data after the first study intervention administration. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). Here, 'n' (number analyzed) specifies the number of participants evaluated at specified timepoints.

Plasma concentration of apalutamide was reported.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=29 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Plasma Concentration of Apalutamide Cycle 02 Day 1, Predose	4.67 micrograms per milliliter (mcg/mL) Standard Deviation 1.19
Plasma Concentration of Apalutamide Cycle 03 Day 1, Predose	4.32 micrograms per milliliter (mcg/mL) Standard Deviation 1.35
Plasma Concentration of Apalutamide Cycle 04 Day 1, Predose	4.05 micrograms per milliliter (mcg/mL) Standard Deviation 1.46
Plasma Concentration of Apalutamide Cycle 05 Day 1, Predose	4.18 micrograms per milliliter (mcg/mL) Standard Deviation 1.38
Plasma Concentration of Apalutamide Cycle 06 Day 1, Predose	4.16 micrograms per milliliter (mcg/mL) Standard Deviation 1.52

SECONDARY outcome

Timeframe: Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)

Population: Pharmacokinetics analysis set included all participants with at least 1 apalutamide and/or N-desmethyl apalutamide concentration data after the first study intervention administration. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated at specified timepoints.

Plasma concentration of N-desmethyl Apalutamide was reported.

Outcome measures

Outcome measures
Measure	Apalutamide + Goserelin n=29 Participants Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Plasma Concentration of N-desmethyl Apalutamide Cycle 02 Day 1, Predose	7.19 mcg/mL Standard Deviation 1.21
Plasma Concentration of N-desmethyl Apalutamide Cycle 03 Day 1, Predose	6.89 mcg/mL Standard Deviation 1.56
Plasma Concentration of N-desmethyl Apalutamide Cycle 04 Day 1, Predose	6.29 mcg/mL Standard Deviation 1.66
Plasma Concentration of N-desmethyl Apalutamide Cycle 05 Day 1, Predose	6.53 mcg/mL Standard Deviation 1.81
Plasma Concentration of N-desmethyl Apalutamide Cycle 06 Day 1, Predose	6.40 mcg/mL Standard Deviation 1.91

Adverse Events

Apalutamide + Goserelin

Serious events: 5 serious events

Other events: 28 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Apalutamide + Goserelin n=31 participants at risk Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Blood and lymphatic system disorders Anaemia	3.2% 1/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Oesophageal Stenosis	3.2% 1/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Cerebral Infarction	3.2% 1/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Renal and urinary disorders Hydronephrosis	3.2% 1/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Laryngeal Oedema	3.2% 1/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	Apalutamide + Goserelin n=31 participants at risk Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	32.3% 10/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Vascular disorders Hot Flush	19.4% 6/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Vascular disorders Hypotension	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	12.9% 4/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Leukopenia	9.7% 3/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Blood and lymphatic system disorders Lymphopenia	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Endocrine disorders Hypothyroidism	19.4% 6/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	9.7% 3/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	12.9% 4/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Stomatitis	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
General disorders Malaise	16.1% 5/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Infections and infestations Upper Respiratory Tract Infection	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Radiation Skin Injury	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Investigations Blood Creatinine Increased	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Investigations Blood Thyroid Stimulating Hormone Increased	9.7% 3/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Investigations Weight Decreased	12.9% 4/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased Appetite	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypertriglyceridaemia	9.7% 3/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	16.1% 5/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Dizziness	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	9.7% 3/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Psychiatric disorders Insomnia	16.1% 5/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dysphonia	6.5% 2/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dry Skin	9.7% 3/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Rash	25.8% 8/31 • Up to 13 months Safety analysis set included all participants who received at least 1 dose of study intervention.

Additional Information

Executive Medical Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER