Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP) (NCT03391973) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP)
Canada33 participantsStarted 2018-08-24
Plain-language summary
Abbreviated Title: Pembrolizumab in Patients with Poor-Prognosis Carcinoma of Unknown Primary Site (CUP) Trial Phase: 2 Clinical Indication: Treatment naïve patients with poor prognosis carcinoma of unknown primary site Trial Type: Single arm phase 2 Type of control: Not applicable Route of administration: Intravenous Trial Blinding: Not applicable Treatment Groups: 1) Pembrolizumab 200 mg IV every 3 weeks for up to 24 months. Total Number of trial subjects:25 Estimated enrollment period: 24 months Estimated duration of trial: 48 months Duration of Participation: 24 months
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. Have adenocarcinoma, a poorly differentiated carcinoma, or any squamous cell carcinomas.
. Be willing and able to provide written informed consent for this trial.
. Be ≥ 18 years of age on day of signing informed consent.
. Have documented measurable disease based on RECIST 1.1. via Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants That Develop an Objective Response to Treatment (Objective Response Rate, ORR).
Timeframe: Within 3 years
2
Duration of Response and Disease Control
Timeframe: Within 3 years
3
Incidence of Treatment-related Adverse Events (TRAEs)
. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 calendar days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived Formalin-Fixed, Paraffin-Embedded (FFPE) Block(s).
. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. 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.
Exclusion criteria
. 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).
. Patient subgroups that are suitable for well-defined treatments: (e.g. women with adenocarcinoma involving axillary lymph nodes as the only site of disease, women with papillary serous carcinoma of the peritoneum, patients with squamous cell carcinoma that involved either cervical or inguinal lymph nodes only, patients with poorly differentiated carcinomas that suggested germinal tumors and with elevated levels of β-hCG and/or AFP, and patients with carcinoma that involved a single, potentially resectable site) also are excluded from enrollment.
. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
. Has a confirmed diagnosis of immunodeficiency or is receiving documented systemic steroid therapy or any other form of immunosuppressive therapy within 7 calendar days prior to the first dose of Pembrolizumab.
. Has a known history of active Tuberculosis Bacillus (TB).
. Hypersensitivity to Pembrolizumab or any of its excipients (L-histidine, L-histidine hydrochloride monohydrate, Sucrose or Polysorbate 80).
. Has had radiation therapy within 14 calendar days prior to the first dose of treatment. If subject undergone radiation, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy as per the discretion of the Qualified Investigator.
. Has had prior chemotherapy, targeted small molecule therapy, or prior anti-cancer mAb.