A Phase 2 interventional study of Pembrolizumab Injection in Carcinoma of Unknown Primary, sponsored by AHS Cancer Control Alberta. Completed at 3 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by AHS Cancer Control Alberta · Phase 2, Interventional, and Treatment
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
This is a multi-centre, single arm phase 2 study of Pembrolizumab (Keytruda™ or MK-3475) in treatment naïve patients with poor prognosis carcinoma of unknown primary site (CUP). Participants will receive Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months. Patients will be evaluated for response every 9 weeks. Patients with objective response to treatment and those with stable disease will continue to receive Pembrolizumab. Patients with tumor progression will be discontinued from the study. Patients with progressive disease (PD), but showing a clinical benefit, may continue on Pembrolizumab, as per the discretion of the responsible Qualified Investigator. Response will be evaluated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
101 studies on the registry are indexed under Neoplasms, Unknown Primary; 19 are open to participants now.
This study's enrollment of 33 is below the median of 52 across 63 interventional studies indexed under Neoplasms, Unknown Primary.
Browse Neoplasms, Unknown Primary studies →AHS Cancer Control Alberta is the lead sponsor of 187 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1 - Pembrolizumab injection dosed at 200 mg given Q3 weeks by IV infusion on Day 1 of each 3 week cycle.
Drug: Pembrolizumab Injection
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.
Also known as: Keytruda
Number of Participants That Develop an Objective Response to Treatment (Objective Response Rate, ORR).
The objective response rate will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST v1.1, tumor response was assessed using MRI or CT imaging. Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) as a ≥30% decrease in the sum of diameters of target lesions from baseline; Stable Disease (SD) as neither sufficient tumor shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD); and PD as a ≥20% increase in the sum of diameters of target lesions or the appearance of new lesions. Disease Control Rate (DCR) was defined as the proportion of participants who achieved CR, PR, or SD as their best overall response during the assessment period, reflecting the ability of treatment to prevent disease progression. The RECIST median duration of response is the time, measured from the first date of CR or PR to PD or death.
Time frame: Within 3 years
Duration of Response and Disease Control
The duration of response and disease control will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST v1.1, tumor response was assessed using MRI or CT imaging. Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) as a ≥30% decrease in the sum of diameters of target lesions from baseline; Stable Disease (SD) as neither sufficient tumor shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease; and Progressive Disease (PD) as a ≥20% increase in the sum of diameters of target lesions (with an absolute increase of at least 5 mm) or the appearance of new lesions. Disease Control Rate (DCR) was defined as the proportion of participants who achieved CR, PR, or SD as their best overall response during the assessment period, reflecting the ability of treatment to prevent disease progression. The Duration of Response is the time, measured from the first date of CR or PR to PD or death.
Time frame: Within 3 years
Incidence of Treatment-related Adverse Events (TRAEs)
Treatment related adverse events will be assessed using CTCAE v4.0.
Time frame: Within 3 years
The Overall Survival (OS) of Participants.
OS is the time from treatment initiation to death due to any cause
Time frame: Within 4 years
The Progression Free Survival (PFS) of Participants.
Progression is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded since treatment started (nadir), with an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Time frame: Within 4 years
| Milestone | Arm 1 - Pembrolizumab |
|---|---|
| Started | 33 |
| Completed | 27 |
| Not completed | 6 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Physician decision | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Development intercurrent illness preventing ongoing treatment | 1 |
The objective response rate will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST v1.1, tumor response was assessed using MRI or CT imaging. Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) as a ≥30% decrease in the sum of diameters of target lesions from baseline; Stable Disease (SD) as neither sufficient tumor shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD); and PD as a ≥20% increase in the sum of diameters of target lesions or the appearance of new lesions. Disease Control Rate (DCR) was defined as the proportion of participants who achieved CR, PR, or SD as their best overall response during the assessment period, reflecting the ability of treatment to prevent disease progression. The RECIST median duration of response is the time, measured from the first date of CR or PR to PD or death.
| Participants | Arm 1 - Pembrolizumab |
|---|---|
| Objective Response Rate | 3 |
| Complete Response | 1 |
| Partial Response | 2 |
| Stable Disease | 11 |
| Progressive Disease | 13 |
| Disease Control Rate | 14 |
The duration of response and disease control will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST v1.1, tumor response was assessed using MRI or CT imaging. Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) as a ≥30% decrease in the sum of diameters of target lesions from baseline; Stable Disease (SD) as neither sufficient tumor shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease; and Progressive Disease (PD) as a ≥20% increase in the sum of diameters of target lesions (with an absolute increase of at least 5 mm) or the appearance of new lesions. Disease Control Rate (DCR) was defined as the proportion of participants who achieved CR, PR, or SD as their best overall response during the assessment period, reflecting the ability of treatment to prevent disease progression. The Duration of Response is the time, measured from the first date of CR or PR to PD or death.
| Months | Arm 1 - Pembrolizumab |
|---|---|
| Median Duration of Response | 22.12 (16.33 to NA) |
| Median Duration of Disease Control | 6.39 (3.09 to 8.44) |
Treatment related adverse events will be assessed using CTCAE v4.0.
| Number of Events | Arm 1 - Pembrolizumab |
|---|---|
| Serious Adverse Events (possibly related) | 2 |
| Adverse Events (possibly related) | 55 |
OS is the time from treatment initiation to death due to any cause
| months | Arm 1 - Pembrolizumab |
|---|---|
| The Overall Survival (OS) of Participants. | 9.49 (3.84 to 14.72) |
Progression is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded since treatment started (nadir), with an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
| months | Arm 1 - Pembrolizumab |
|---|---|
| The Progression Free Survival (PFS) of Participants. | 2.98 (2.07 to 4.63) |
Collected over Serious and Other Adverse Events were monitored/assessed from the time that informed consent is signed until cessation of treatment or until the beginning of a new anti-neoplastic therapy, whichever occurs first, up to 3 years. All-cause Mortality was assessed for up to 4 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 - Pembrolizumab | 26/27 (96.3%) | 2/27 (7.4%) | 27/27 (100%) |
| Event | Arm 1 - Pembrolizumab |
|---|---|
| Fatigue, generalized weaknessGeneral disorders | 1/27 |
| Fever, nausea, vomitingGastrointestinal disorders | 1/27 |
| Event | Arm 1 - Pembrolizumab |
|---|---|
| Fatigue/malaise/weaknessGeneral disorders | 7/27 |
| Joint PainMusculoskeletal and connective tissue disorders | 6/27 |
| NauseaGeneral disorders | 5/27 |
| RashSkin and subcutaneous tissue disorders | 4/27 |
| PruritisSkin and subcutaneous tissue disorders | 4/27 |
| Cough/DyspneaRespiratory, thoracic and mediastinal disorders | 4/27 |
| VomitingGastrointestinal disorders | 3/27 |
| Anorexia/Decreased food intakeGeneral disorders | 2/27 |
| DiarrheaGastrointestinal disorders | 2/27 |
| FeverGeneral disorders | 2/27 |
Eligible patients were identified and treated at 3 academic cancer centers in Canada, (Tom Baker Cancer Centre now the Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta; Cross Cancer Institute, Edmonton, Alberta; Ottawa Cancer Centre, Ottawa, Ontario). Eligible patients were 18 years of age or older, and have histologically documented, metastatic carcinoma with no primary site identified.
| Age, Customized(years) | Arm 1 - Pembrolizumab |
|---|---|
| Age | 64 (21 to 80) |
| Sex: Female, Male(Participants) | Arm 1 - Pembrolizumab |
|---|---|
| Female | 14 |
| Male | 19 |
| Race and Ethnicity Not Collected(Participants) | Arm 1 - Pembrolizumab |
|---|
| ECOG(Participants) | Arm 1 - Pembrolizumab |
|---|---|
| 0 | 5 |
| 1 | 28 |
| Histology(Participants) | Arm 1 - Pembrolizumab |
|---|---|
| Adenocarcinoma | 22 |
| Squamous Cell Carcinoma | 2 |
| Poorly Differentiated | 8 |
| Other | 1 |
| Sites of Metastatic Disease(Participants) | Arm 1 - Pembrolizumab |
|---|---|
| Lung | 14 |
| Liver | 23 |
| Bone | 8 |
| Lymph Nodes | 20 |
| Skin/soft tissues | 1 |
| Genitourinary | 1 |
| Other | 8 |
| Number of Metastatic Sites(Participants) | Arm 1 - Pembrolizumab |
|---|---|
| 1 | 5 |
| 2 | 12 |
| 3 or more | 16 |
| Baseline Endoscopy(Participants) | Arm 1 - Pembrolizumab |
|---|---|
| Baseline upper and lower endoscopy | 22 |
| Baseline upper and no lower endoscopy | 2 |
| Baseline lower and no upper endoscopy | 2 |
| No endoscopy | 7 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab