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PD-1 Inhibitor

Pembrolizumab for Cancer of Unknown Primary (CUP Trial)

Phase 2
Waitlist Available
Led By Jose Monzon, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a documented negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication if female and of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.
Have histologically (or cytologically) documented, metastatic carcinoma with no primary site identified. The following tests are required to exclude a primary site of disease: complete history and physical examination, blood chemistry (including serum tumor marker for prostate-specific antigen (PSA) in men, alpha-fetoprotein (AFP), β-human chorionic gonadotropin (β-hCG)) and mammography in women, urinalysis, thoracic and abdominopelvic computed tomography scans, bone scan, and symptom or sign-oriented imaging or endoscopic studies.
Must not have
CUP suspected to be lymphomas (e.g. staining for leukocyte common antigen), malignant melanoma (e.g. staining for both S100 and HMB45), extragonadal germ cell neoplasms (e.g. staining for both AFP and β-hCG), sarcomas (e.g. staining for cytokeratins and vimentin), neuroendocrine tumors (e.g. staining for chromogranin and synaptophysin), and prostatic adenocarcinomas in men (e.g. staining for PSA).
Has an active infection requiring systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the drug pembrolizumab can help treat patients with a type of cancer that is difficult to treat and often has a poor prognosis.

Who is the study for?
This trial is for adults with metastatic carcinoma of unknown primary site (CUP) who haven't had prior cancer treatments. Participants need to have a specific performance status, provide tissue samples, and use contraception if applicable. Excluded are those with certain other cancers or conditions, recent immunosuppressive therapy, active infections, known allergies to Pembrolizumab components, or CNS metastases.
What is being tested?
The study tests Pembrolizumab injections given intravenously every three weeks for up to two years in patients with poor-prognosis CUP. It's a phase 2 trial without a control group where all 25 participants receive the same treatment to evaluate its effectiveness and safety.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), infusion reactions during administration of the drug and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have confirmed I am not pregnant through a test within the last week.
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My cancer's origin is unknown, but I've undergone tests to try to find its source.
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My cancer can be measured by scans.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My cancer is either adenocarcinoma, poorly differentiated carcinoma, or squamous cell carcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is suspected to be a specific type based on certain tests.
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I am currently being treated for an infection.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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My cancer does not fit into specific groups that have clear treatment options.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.
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I am allergic to Pembrolizumab or its ingredients.
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I have had chemotherapy, targeted therapy, or antibody treatment for cancer.
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I have had an organ or bone marrow transplant.
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I have been diagnosed with HIV.
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I have had pneumonitis before, but it wasn't caused by an infection.
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I have an active TB infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 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
Number of participants that develop an adverse event to treatment.
Therapeutic procedure
Secondary study objectives
The duration of response (DOR) of participants.
The overall survival (OS) of participants.
The progression free survival (PFS) of participants.

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT04099641
34%
Decreased appetite
33%
Fatigue
30%
Nausea
26%
Diarrhoea
26%
Constipation
25%
Vomiting
23%
Anaemia
21%
Abdominal pain
18%
Dyspnoea
16%
Oedema peripheral
16%
Weight decreased
15%
Pyrexia
15%
Dizziness
13%
Aspartate aminotransferase increased
13%
Abdominal pain upper
13%
Alanine aminotransferase increased
13%
Chills
11%
Arthralgia
11%
Myalgia
11%
Gastric cancer
11%
Headache
11%
Hypertension
11%
Hypothyroidism
10%
Asthenia
10%
Back pain
10%
Abdominal distention
10%
Hypoalbuminaemia
8%
Insomnia
8%
Depression
8%
Urinary tract infection
8%
Ascites
8%
Dysphagia
8%
Muscular weakness
8%
Rash
7%
Blood creatinine increased
7%
Dyspepsia
7%
Fall
7%
Hyponatraemia
7%
Blood alkaline phosphatase increased
7%
Pleural effusion
5%
Infusion related reaction
5%
Dysuria
5%
Hyperkalaemia
5%
Abdominal discomfort
5%
Dry skin
5%
Hypotension
3%
Death
3%
Generalized oedema
3%
Hypophosphataemia
3%
Blood bilirubin increased
3%
Peripheral sensory neuropathy
3%
Hypokalaemia
3%
Cough
3%
Vision blurred
3%
Upper gastrointestinal haemorrhage
3%
Dehydration
2%
Encephalopathy
2%
Upper respiratory tract infection
2%
Facial paralysis
2%
Obstruction gastric
2%
Disease progression
2%
Respiratory failure
2%
Acute respiratory failure
2%
Multiple organ dysfunction syndrome
2%
Large intestinal obstruction
2%
Corona virus infection
2%
Neutrophil count decreased
2%
Malignant urinary tract obstruction
2%
Gastrointestinal haemorrhage
2%
Blood cholesterol increased
2%
Acute kidney injury
2%
Hypoxia
2%
Loss of consciousness
2%
Oesophageal cancer metastatic
2%
Pelvic pain
2%
Biliary tract infection
2%
Transient ischaemic attack
2%
Acute myocardial infarction
2%
Atrioventricular block
2%
Cardiac arrest
2%
Cancer pain
2%
Malignant ascites
2%
Metastatic gastric cancer
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
2%
Pneumonia aspiration
2%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (CPI Naïve)
Group 2 (CPI Relapse)

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: Arm 1 - PembrolizumabExperimental Treatment1 Intervention
Arm 1 - Pembrolizumab injection dosed at 200 mg given Q3 weeks by IV infusion on Day 1 of each 3 week cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab Injection
2019
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,899 Total Patients Enrolled
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,805 Total Patients Enrolled
Jose Monzon, MDPrincipal InvestigatorAlberta Health services

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03391973 — Phase 2
Cancer of Unknown Primary Research Study Groups: Arm 1 - Pembrolizumab
Cancer of Unknown Primary Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03391973 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03391973 — Phase 2
~4 spots leftby Nov 2025
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