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Hormone Therapy

ADT + Pembrolizumab for Salivary Gland Cancer

Phase 2
Recruiting
Led By Manish Patel, MD
Research Sponsored by Manish Patel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Locally advanced, recurrent, or metastatic salivary gland carcinoma that is not amenable to curative surgery or radiation
For patients who have been treated with prior therapy, patients must have documented progression of disease on their prior therapy for entry into the study.
Must not have
Has an active infection requiring systemic therapy.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for salivary gland cancer that has spread or come back and is not able to be treated with surgery or radiation.

Who is the study for?
This trial is for adults with advanced salivary gland carcinoma that can't be removed by surgery or treated with radiation. Participants must have adequate organ function, no recent serious illnesses, and agree to use contraception. They should not have had certain prior treatments like anti-androgen therapy or immune checkpoint inhibitors.
What is being tested?
The study tests a combination of Androgen Deprivation Therapy (ADT) using Goserelin Acetate and Pembrolizumab in patients with androgen receptor-positive salivary gland cancer. It's a Phase II trial where all participants receive the same treatment without being compared to another group.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, fatigue, skin rash, hormonal changes due to ADT (like hot flashes), injection site reactions from Pembrolizumab, and potential blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My salivary gland cancer cannot be cured with surgery or radiation.
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My condition worsened after my last treatment.
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I've had treatments like chemotherapy or surgery for cancer, but not anti-androgen therapy or immune checkpoint inhibitors.
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My kidney function, measured by creatinine or GFR, is within the required range.
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I am 18 years old or older.
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I have been mostly active and able to carry on all pre-disease activities without restriction recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for an infection.
Select...
I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
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I had palliative radiotherapy within the last week and have recovered from side effects.
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I have undergone hormone therapy for cancer, including treatments like orchiectomy or medications such as abiraterone.
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I have received a transplant from another person.
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I haven't had any cancer treatment or experimental drugs in the last 14 days.
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I have or had lung inflammation not caused by infection, treated with steroids.
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I am not on high-dose steroids or other drugs that weaken my immune system.
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I have been treated with specific immune therapy drugs before.
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I have been diagnosed with HIV.
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I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate
Secondary study objectives
Assess Adverse Events
Disease Control Rate
Overall Survival
+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Goserelin Acetate + PembrolizumabExperimental Treatment2 Interventions
Goserelin Acetate, 3.6 mg, every four weeks, SQ Pembrolizumab, 200mg, every three weeks, IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150
Goserelin Acetate
2007
Completed Phase 3
~1040

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,022 Previous Clinical Trials
5,187,150 Total Patients Enrolled
TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,321 Total Patients Enrolled
Manish PatelLead Sponsor

Media Library

Goserelin Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03942653 — Phase 2
Salivary Gland Cancer Research Study Groups: Goserelin Acetate + Pembrolizumab
Salivary Gland Cancer Clinical Trial 2023: Goserelin Acetate Highlights & Side Effects. Trial Name: NCT03942653 — Phase 2
Goserelin Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03942653 — Phase 2
~2 spots leftby Sep 2025
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