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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
Local, pathologic testing of androgen receptor-positive salivary gland carcinoma will be performed as standard of care. Archival tissue must be available for central confirmation of androgen receptor-positive disease and for correlative studies. AR positivity will be defined according to IHC staining of tumor tissue with at least 20% of tumor staining positive with moderate intensity (1+ or greater).
Adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My salivary gland cancer is confirmed to be androgen receptor-positive.
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My organ functions are within normal ranges as per recent tests.
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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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My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.
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I have recovered from previous cancer treatment side effects, except for hair loss.
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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 not pregnant and can prove it with a test taken in the last 3 days.
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My liver function tests are within the required range.
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I agree to use birth control and not donate sperm for 8 months after my last treatment dose.
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I am 18 years old or older.
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My cancer can be measured by scans taken within the last 28 days.
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I have been mostly active and able to carry on all pre-disease activities without restriction recently.
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I can understand and follow the study's procedures for its duration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 35 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Assess Adverse Events
Disease Control Rate
Overall Survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 2
~2010
Goserelin Acetate
2007
Completed Phase 3
~1040
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,674 Total Patients Enrolled
TerSera Therapeutics LLCIndustry Sponsor
9 Previous Clinical Trials
1,429 Total Patients Enrolled
Manish PatelLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My salivary gland cancer is confirmed to be androgen receptor-positive.I am currently being treated for an infection.My organ functions are within normal ranges as per recent tests.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My salivary gland cancer cannot be cured with surgery or radiation.I had palliative radiotherapy within the last week and have recovered from side effects.I have not received a live vaccine in the last 28 days.My condition worsened after my last treatment.My brain metastases are stable, and I haven't needed steroids for 14 days.I have undergone hormone therapy for cancer, including treatments like orchiectomy or medications such as abiraterone.I have another cancer besides skin or in situ cancers that needed treatment in the last 2 years.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I have recovered from previous cancer treatment side effects, except for hair loss.My kidney function, measured by creatinine or GFR, is within the required range.I am not pregnant and can prove it with a test taken in the last 3 days.My liver function tests are within the required range.I agree to use birth control and not donate sperm for 8 months after my last treatment dose.I've had treatments like chemotherapy or surgery for cancer, but not anti-androgen therapy or immune checkpoint inhibitors.I have received a transplant from another person.I haven't had any cancer treatment or experimental drugs in the last 14 days.I am 18 years old or older.I have or had lung inflammation not caused by infection, treated with steroids.I am not on high-dose steroids or other drugs that weaken my immune system.I have been treated with specific immune therapy drugs before.I have been diagnosed with HIV.I have an active tuberculosis infection.My cancer can be measured by scans taken within the last 28 days.I have been mostly active and able to carry on all pre-disease activities without restriction recently.I am of childbearing age and have a positive pregnancy test.I can understand and follow the study's procedures for its duration.You have had a severe allergic reaction to pembrolizumab or any of its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Goserelin Acetate + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining slots for participants in this medical test?
"The available information on clinicaltrials.gov confirms the recruitment status of this trial, which was first made accessible to potential participants on May 30th 2019 and recently updated on September 22nd 2022."
Answered by AI
Has this trial been implemented in any North American locales?
"Northwestern University Feinberg School of Medicine, located in Chicago, Illinois; the Masonic Cancer Center at The Univeristy of Minnesota in Minneapolis; and the Univeristy of Maryland based out of Baltimore are three primary sites for this trial. An additional 7 medical centres round out its locations."
Answered by AI
Has Pembrolizumab been tested as part of any other medical experiments?
"The first evaluation of pembrolizumab occurred in 2000 at Centre de Recherche Clinique du CHUS. As of now, 340 clinical trials have been completed and 1027 are still recruiting participants - with a significant portion based out of Chicago, Illinois."
Answered by AI
How many individuals have joined the trial to date?
"Affirmative. The information on clinicaltrials.gov indicates that this research is currently recruiting participants; the trial was first announced on May 30th 2019, and recently updated on September 22nd 2022. There are 20 openings across 7 medical locations."
Answered by AI
Has Pembrolizumab received governmental authorization for therapeutic use?
"While safety data is present, the efficacy of pemrolizumab has yet to be established. This leads us at Power to rate its respective level of security as a 2 on our scale."
Answered by AI
Does this research endeavor offer any fresh insights?
"Ever since it was first studied by AstraZeneca in 2000, Pembrolizumab has been extensively researched. After the initial trial involving 600 participants was conducted, clinical trials of pembrolizumab were approved for phase 3 drug testing and now 1027 studies are underway across 65 countries and 3157 cities."
Answered by AI
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