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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
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 • NCT0304099964%
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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
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
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.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,527 Previous Clinical Trials
503,545 Total Patients Enrolled
14 Trials studying Ovarian Cancer
3,032 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: Not ApplicableYou have a specific type of ovarian cancer called small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).
Research Study Groups:
This trial has the following groups:- Group 1: 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.