What side effects are associated with this type of intervention?

Common side effects of treatments for thyroid cancer, particularly with immune checkpoint inhibitors like pembrolizumab, include skin reactions (rash, pruritus), endocrine disorders (hypothyroidism, adrenal insufficiency), gastrointestinal issues (diarrhea, colitis), and pneumonitis. Severe adverse events can also occur, such as hepatitis, nephritis, and myocarditis. These side effects result from the enhanced immune response against cancer cells, which can also affect normal tissues.

What prior FDA approvals exist?

Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, is being studied in the treatment of anaplastic thyroid cancer (ATC) in a phase II trial. This trial involves adjuvant pembrolizumab following external beam radiation. While the context does not provide specific prior FDA approvals for thyroid cancer treatments similar to pembrolizumab, it is known that immune checkpoint inhibitors like pembrolizumab have been approved for other cancers, such as non-small cell lung cancer and melanoma, indicating their broader applicability in oncology.

What other types of research exist?

Promising alternatives to Pembrolizumab for thyroid cancer patients include Nivolumab, another PD-1 inhibitor, and Atezolizumab, a PD-L1 inhibitor. Additionally, combination therapies involving immune checkpoint inhibitors and targeted therapies or chemotherapy are being explored. Emerging treatments such as Relatlimab (a LAG-3 inhibitor) combined with Nivolumab are also showing potential in clinical trials.

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Pembrolizumab Post-IMRT for Thyroid Cancer

Q: What is the mechanism of action of this treatment?

Pembrolizumab is an immune checkpoint inhibitor that targets the PD-1 (programmed cell death protein 1) pathway. By blocking PD-1, Pembrolizumab prevents cancer cells from evading the immune system, thereby enhancing the body's ability to detect and destroy cancer cells. This mechanism is particularly important for thyroid cancer patients as it offers a novel therapeutic approach that can potentially improve outcomes in cases where traditional treatments, such as surgery and radioactive iodine, are ineffective. The ability to harness the immune system provides a promising avenue for managing advanced or refractory thyroid cancers.

Phase 2

Recruiting

Led By Maria Cabanillas

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage IVB disease with unresectable disease or complete resection of tumor without convincing evidence of metastatic disease in the neck

Male/female participants who are at least 18 years of age with pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma

Must not have

Prior therapy with specific agents or directed to T-cell receptors

Male participant not agreeing to use contraception and refrain from donating sperm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if pembrolizumab, given after radiation therapy, can help patients with advanced anaplastic thyroid cancer in the neck live longer without their disease getting worse. Pembrolizumab works by boosting the immune system to attack cancer cells and is used to treat various cancers.

Who is the study for?

This trial is for adults with stage IVB anaplastic thyroid cancer (ATC) who have completed radiation therapy, possibly with chemotherapy. They must be in good health overall, not pregnant or breastfeeding, and willing to use contraception. Those with certain prior treatments or immunodeficiencies, recent vaccinations, or specific genetic mutations are excluded.

What is being tested?

The trial tests pembrolizumab as an additional treatment after radiation for ATC. It aims to see how long patients can live without their cancer getting worse after this combination of therapies. Participants will receive pembrolizumab following either high-dose (>51 Gy) or lower-dose (<50 Gy) radiation.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs like the lungs and intestines, skin reactions, hormone gland problems (like thyroid), fatigue, infusion reactions and could potentially worsen pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced but hasn’t spread to my neck.

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I am 18 or older with a diagnosis of anaplastic thyroid cancer.

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I am fully active or can carry out light work.

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I have finished radiation therapy, with or without chemotherapy.

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I am not pregnant, not breastfeeding, and follow birth control guidelines.

Exclusion Criteria

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

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I have had previous treatments targeting my immune system.

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I am a male and agree to use contraception and not donate sperm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: PembrolizumabExperimental Treatment1 Intervention

The infusions are given every 6 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pembrolizumab is an immune checkpoint inhibitor that targets the PD-1 (programmed cell death protein 1) pathway. By blocking PD-1, Pembrolizumab prevents cancer cells from evading the immune system, thereby enhancing the body's ability to detect and destroy cancer cells. This mechanism is particularly important for thyroid cancer patients as it offers a novel therapeutic approach that can potentially improve outcomes in cases where traditional treatments, such as surgery and radioactive iodine, are ineffective. The ability to harness the immune system provides a promising avenue for managing advanced or refractory thyroid cancers.

Endocrinopathies Associated with Immune Checkpoint Inhibitor Cancer Treatment: A Review.Endocrine, Sexual Function, and Infertility Side Effects of Immune Checkpoint Inhibitor Therapy for Genitourinary Cancers.