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PD-1 Inhibitor
Pemetrexed + Pembrolizumab for Salivary Gland Cancer
Phase 2
Recruiting
Led By Katherine A. Price, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Histologically confirmed diagnosis of recurrent or metastatic salivary gland cancer not amenable to curative-intent therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests the effect of combining two cancer treatments: chemotherapy drug pemetrexed with immunotherapy drug pembrolizumab. The purpose is to see if this combo is more effective than pemetrexed alone in treating patients with recurrent or metastatic salivary gland cancer.
Who is the study for?
Adults with advanced salivary gland cancer that has returned or spread and can't be cured by surgery. They should have a life expectancy of at least 12 weeks, good organ function, no severe illnesses that could interfere with the study, and must agree to use contraception. Prior treatments are allowed but there are restrictions on recent surgeries, therapies, and certain medications.Check my eligibility
What is being tested?
The trial is testing the combination of pemetrexed (a chemotherapy drug) and pembrolizumab (an immunotherapy antibody) in patients with recurrent or metastatic salivary gland cancer. The goal is to see if this combo can stop cancer cells from growing by killing them directly or boosting the immune system's response.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune responses), infusion-related reactions from receiving drugs through a vein, fatigue, blood disorders like low platelet counts or anemia, increased risk of infections due to weakened immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My salivary gland cancer has returned or spread and cannot be cured with surgery or radiation.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed response rate
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression-free survival
Other outcome measures
Degree of PDL1 expression using formalin-fixed tumor samples
Expression of thymidylate synthase
Frequency of MTAP loss
Side 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: Treatment (pembrolizumab, pemetrexed)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Pemetrexed Disodium
2015
Completed Phase 2
~280
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,960 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,767,018 Total Patients Enrolled
Katherine A. Price, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids or currently have it.I have not received any live vaccines or been part of a drug study in the last 4 weeks.I am willing to give tissue samples for research.I have received an organ or tissue transplant from another person.I am HIV-positive and my condition is well-managed with medication.I am 18 years old or older.I have an active HIV infection with a CD4+ count below 500/ml and am not on anti-retroviral treatment.I do not have any severe ongoing illnesses that would interfere with the study.I have had certain types of cancer but am now considered to have less than a 30% risk of it coming back.I only use steroids for allergies, asthma, or local pain, not more than 10 mg/day of prednisone.My salivary gland cancer has returned or spread and cannot be cured with surgery or radiation.My kidney function, measured by creatinine levels or clearance, is within the required range.My blood clotting tests are normal or within the target range if I'm on blood thinners.My cancer has spread to the lining of my brain and spinal cord.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I may have certain stable conditions or use specific medications, but not as a form of systemic treatment.I have recovered from radiation side effects and don't need steroids or have lung inflammation from radiation.I haven't taken immunosuppressive drugs in the last 14 days.I have not had any other cancer within the last 2 years.I agree to use birth control during and for 6 months after treatment.I haven't had cancer surgery, systemic therapy, or radiation within the last 3 weeks.I have not received a live vaccine in the last 4 weeks.I have recovered from side effects of past treatments or surgeries.I have active cancer spread to my brain or spinal cord.I may have mild neuropathy, fatigue, or hair loss.My brain metastases are stable, not growing, and I haven't used steroids in the last 14 days.I had a severe reaction to previous immunotherapy.I have had severe side effects from immunotherapy, especially affecting my nerves or eyes.I had mild hormone-related side effects but am stable on my current hormone therapy.My cancer has grown in an area previously treated with radiation.I have previously been treated with checkpoint inhibitors for my cancer.I am fully active or can carry out light work.My health status meets the criteria without needing extra help from medications or recent blood transfusions.I have previously been treated with checkpoint inhibitors.I may have had any number of treatments for my cancer that has come back or spread.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, pemetrexed)
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.
What is the FDA's current stance on Pembrolizumab?
"Pembrolizumab was given a score of 2 by our team at Power. This is because, although there is data supporting its safety, there is none yet affirming its efficacy--as is typical for Phase 2 trials."
Answered by AI
What prior research has been conducted with Pembrolizumab?
"Pembrolizumab was first studied in 2005 at Hematology-Oncology Associates of Illinois. Since then, a total 533 clinical trials have completed. There are 1174 live clinical trials as of now, with many of them based in Jacksonville, Florida."
Answered by AI
Are we enrolling patients for this research project at the moment?
"Yes, this trial is still recruiting patients according to the information available on clinicaltrials.gov. The study was originally posted on 7/23/2021 and was most recently updated on 3/15/2022."
Answered by AI
What cancers has Pembrolizumab been most successful in treating?
"Pembrolizumab is the standard of care for treating unresectable melanoma. Pembrolizumab has also shown efficacy in other conditions, such as microsatellite instability high, locally advanced nonsquamous non-small cell lung cancer, and high risk of recurrence."
Answered by AI
How many patients are included in this clinical trial?
"The most recent update on clinicaltrials.gov affirms that this study is still recruiting patients. This research project was initially posted on July 23rd, 2021 and was last edited March 15th, 2022. In total, the trial needs 45 individuals from 5 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
As a high school science teacher at a DoDEA school in Puerto Rico I realize the importance of research to make advances in the treatment of Adenoid Cystic Carcinoma. With the limited research I have made I am not liking my probability of survival. If your trail might help me then I am willing to give it a try.
PatientReceived no prior treatments
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