What side effects are associated with this type of intervention?

Pembrolizumab, an immune checkpoint inhibitor targeting the PD-1 receptor, is associated with side effects such as fatigue, rash, pruritus, diarrhea, and pneumonitis. Severe immune-related adverse events can include colitis, hepatitis, endocrinopathies, and nephritis. Common side effects of chemotherapy for ovarian cancer, which may be used in combination with pembrolizumab, include nausea, vomiting, hair loss, anemia, increased risk of infection, and neuropathy. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Pembrolizumab, an immune checkpoint inhibitor targeting the PD-1 receptor, has been studied for various cancers, including ovarian cancer. While pembrolizumab itself is being investigated for ovarian cancer, other similar drugs like nivolumab (another PD-1 inhibitor) and avelumab (a PD-L1 inhibitor) have also been explored in clinical trials for ovarian cancer. These drugs work by enhancing the immune system's ability to fight cancer cells. Although pembrolizumab is not yet broadly approved for ovarian cancer, it represents a promising area of research in the treatment of this disease.

What other types of research exist?

Promising alternatives to Pembrolizumab for ovarian cancer patients include Bevacizumab, which has been studied in combination with chemotherapy for platinum-resistant ovarian cancer, and Nivolumab, which has shown efficacy in various cancers and may be considered for ovarian cancer. Additionally, Atezolizumab and Ipilimumab are other immune checkpoint inhibitors that could be explored as potential treatments.

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Pembrolizumab for Small Cell Carcinoma of Ovary (Pemb-HT Trial)

N/A

Waitlist Available

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab, a drug that helps the immune system fight cancer, in a patient with a rare and aggressive type of ovarian cancer called SCCOHT. Pembrolizumab has shown effectiveness in various cancers, including melanoma, lung cancer, and kidney cancer. This type of cancer has no standard treatment, making this trial important for finding new options.

Who is the study for?

This trial is specifically for patients who have been diagnosed with a rare type of ovarian cancer known as small cell carcinoma of the ovary, hypercalcemic type (SCCOHT). There are no listed exclusion criteria, suggesting it may be open to a wide range of people with this condition.

What is being tested?

The study is testing pembrolizumab as an additional treatment after initial therapy for SCCOHT. Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer cells.

What are the potential side effects?

Pembrolizumab can cause side effects like fatigue, cough, nausea, itching, skin rash, loss of appetite and diarrhea. It might also lead to more serious conditions involving the lungs, intestines or liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Progression free survival

Secondary study objectives

Exploratory Endpoint

Objective evidence of response to treatment

overall performance status

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

Pembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Do I qualify?Apply below to find out

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

The most common treatments for ovarian cancer include surgery, chemotherapy, targeted therapy, and immunotherapy. Immunotherapy, such as pembrolizumab, works by targeting the PD-1 receptor on T-cells, preventing cancer cells from evading the immune system. This mechanism is crucial as it helps the body's immune system recognize and attack cancer cells more effectively. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells, while targeted therapies like PARP inhibitors interfere with specific molecules involved in cancer cell growth and survival. These treatments are significant for ovarian cancer patients as they offer multiple avenues to combat the disease, potentially improving survival rates and quality of life.