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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

Must not have

History of (non-infectious) pneumonitis that required steroids or has current pneumonitis

NOTES: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed, Received an investigational agent or used an investigational device or participated in a study of an investigational agent < 4 weeks prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or currently have it.

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I have not received any live vaccines or been part of a drug study in the last 4 weeks.

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I have received an organ or tissue transplant from another person.

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I have an active HIV infection with a CD4+ count below 500/ml and am not on anti-retroviral treatment.

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I do not have any severe ongoing illnesses that would interfere with the study.

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My cancer has spread to the lining of my brain and spinal cord.

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I have not had any other cancer within the last 2 years.

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I have recovered from side effects of past treatments or surgeries.

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I have active cancer spread to my brain or spinal cord.

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I had a severe reaction to previous immunotherapy.

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I have had severe side effects from immunotherapy, especially affecting my nerves or eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical benefit rate (CBR)

Confirmed response rate

Secondary study objectives

CBR (non-ACC cohort)

Incidence of adverse events

Overall survival

+2 more

Other study objectives

Degree of PDL1 expression using formalin-fixed tumor samples

Expression of thymidylate synthase

Frequency of MTAP loss

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

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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: Treatment (pembrolizumab, pemetrexed)Experimental Treatment7 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. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030