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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 years
Awards & highlights
CUP Trial 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.Check my eligibility
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.See study design
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.
CUP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have confirmed I am not pregnant through a test within the last week.
Select...
My cancer's origin is unknown, but I've undergone tests to try to find its source.
Select...
My cancer can be measured by scans.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
Select...
My cancer is either adenocarcinoma, poorly differentiated carcinoma, or squamous cell carcinoma.
CUP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants that develop an adverse event to treatment.
Therapeutic procedure
Secondary outcome measures
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 • NCT0409964134%
Decreased appetite
33%
Fatigue
30%
Nausea
26%
Constipation
26%
Diarrhoea
25%
Vomiting
23%
Anaemia
21%
Abdominal pain
18%
Dyspnoea
16%
Oedema peripheral
16%
Weight decreased
15%
Pyrexia
15%
Dizziness
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Abdominal pain upper
13%
Chills
11%
Gastric cancer
11%
Hypothyroidism
11%
Headache
11%
Hypertension
11%
Myalgia
11%
Arthralgia
10%
Asthenia
10%
Hypoalbuminaemia
10%
Abdominal distention
10%
Back pain
8%
Depression
8%
Insomnia
8%
Ascites
8%
Dysphagia
8%
Urinary tract infection
8%
Muscular weakness
8%
Rash
7%
Dyspepsia
7%
Fall
7%
Hyponatraemia
7%
Pleural effusion
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
5%
Dysuria
5%
Hyperkalaemia
5%
Hypotension
5%
Dry skin
5%
Infusion related reaction
5%
Abdominal discomfort
3%
Upper gastrointestinal haemorrhage
3%
Dehydration
3%
Death
3%
Hypokalaemia
3%
Generalized oedema
3%
Cough
3%
Vision blurred
3%
Peripheral sensory neuropathy
3%
Blood bilirubin increased
3%
Hypophosphataemia
2%
Multiple organ dysfunction syndrome
2%
Atrioventricular block
2%
Biliary tract infection
2%
Cancer pain
2%
Metastatic gastric cancer
2%
Disease progression
2%
Acute myocardial infarction
2%
Corona virus infection
2%
Oesophageal cancer metastatic
2%
Encephalopathy
2%
Acute respiratory failure
2%
Facial paralysis
2%
Loss of consciousness
2%
Transient ischaemic attack
2%
Acute kidney injury
2%
Malignant urinary tract obstruction
2%
Gastrointestinal haemorrhage
2%
Pneumonia aspiration
2%
Pneumonitis
2%
Hypoxia
2%
Respiratory failure
2%
Upper respiratory tract infection
2%
Pelvic pain
2%
Neutrophil count decreased
2%
Blood cholesterol increased
2%
Large intestinal obstruction
2%
Obstruction gastric
2%
Cardiac arrest
2%
Malignant ascites
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (CPI Naïve)
Group 2 (CPI Relapse)
CUP 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
~120
Find a Location
Who is running the clinical trial?
Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,829 Total Patients Enrolled
1 Trials studying Carcinoma
32 Patients Enrolled for Carcinoma
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,186 Total Patients Enrolled
8 Trials studying Carcinoma
284 Patients Enrolled for Carcinoma
Jose Monzon, MDPrincipal InvestigatorAlberta Health services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is suspected to be a specific type based on certain tests.I am currently being treated for an infection.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I agree to use two forms of birth control during and for 120 days after the study.My cancer's origin is unknown, but I've undergone tests to try to find its source.My cancer can be measured by scans.I can provide a recent biopsy sample or an older one if a new sample can't be taken safely.I am fully active or restricted in physically strenuous activity but can do light work.My recent tests show my organs are functioning well.I am using two birth control methods or am not having sex to join this study.I have had chemotherapy, targeted therapy, or antibody treatment for cancer.I have another cancer besides the one being studied, but it's not getting worse or needing treatment, except for certain skin cancers or cervical cancer that's been treated.I have had an organ or bone marrow transplant.I have confirmed I am not pregnant through a test within the last week.My cancer does not fit into specific groups that have clear treatment options.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I am allergic to Pembrolizumab or its ingredients.I have not had radiation therapy in the last 14 days or have recovered from its effects.I have recovered from any major surgery before starting the therapy.I have stable brain metastases and haven't used steroids in the last 7 days.I have been diagnosed with HIV.I have had pneumonitis before, but it wasn't caused by an infection.I have an active TB infection.I am 18 years old or older.I have not received a live vaccine in the last 30 days.I haven't been in a clinical trial for a new drug or device in the last 4 weeks.My cancer is either adenocarcinoma, poorly differentiated carcinoma, or squamous cell carcinoma.I have an autoimmune disease treated with strong medication in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards are associated with Pembrolizumab Injection?
"Our internal assessment at Power ranks the safety of pembrolizumab injection as a 2, considering it is currently undergoing Phase II testing and has yet to demonstrate its efficacy."
Answered by AI
What afflictions does Pembrolizumab Injection typically ameliorate?
"Pembrolizumab Injection is typically used to fight against malignant neoplasms, but can also be taken to treat micrsatellite instability high, unresectable melanoma and disease progression after chemotherapy."
Answered by AI
Are there any current opportunities to take part in this scientific experiment?
"Clinicaltrials.gov implies that this investigation is actively searching for participants; it was initially announced on August 24th 2018 and last revised on February 18th 2022."
Answered by AI
Are there any other investigations which have employed Pembrolizumab Injection?
"Currently, 961 clinical trials researching Pembrolizumab Injection are in progress. Of these studies, 122 have advanced to the third stage of research and a majority is being conducted around Houston, Texas with 35731 other sites also involved in this project."
Answered by AI
How many individuals are involved in this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this trial is currently open for enrolment, having been posted on August 24th 2018 and edited as recently as February 18th 2022. 25 individuals need to be recruited from 3 distinct locations."
Answered by AI
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