A Phase 1/2 interventional study of Pembrolizumab and Radiation Therapy in Soft Tissue Sarcoma and Recurrent Soft Tissue Sarcoma, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Treatment
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Among 20 studies testing pembrolizumab in Sarcoma — 6 open to participants now, 10 under way, none of them phase 3. pembrolizumab · Sarcoma.
Among the 20 studies testing pembrolizumab in Sarcoma, this one is the 16th largest by enrollment, is the only one that started in 2018, is one of 3 in phase 1/2, and was the 9th registered.
1,607 studies on the registry are indexed under Sarcoma; 365 are open to participants now.
Browse Sarcoma studies →6 of the 20 studies testing pembrolizumab in Sarcoma are open now, in 7 countries. Recruiting first, the newest first:
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Yonsei University · Sites in Korea, Republic of
Ages 20–80
Institut Bergonié · Sites in France
Ages 18+
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–70
Niels Junker · Sites in Denmark, Norway, Sweden
Ages 18+
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 301 Sarcoma studies recruiting now, 191 (63%) set no upper age limit and 83 (28%) stop at 75 or younger; 92 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 16
First in 2014; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 27 is below the median of 41 across 1,254 interventional studies indexed under Sarcoma.
Median enrollment 49 across the 20 interventional studies. Of the 9 that completed or were terminated, 6 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 20 have an industry lead sponsor. The 10 most frequent:
Fred Hutchinson Cancer Center is the lead sponsor of 547 studies on the registry; 80 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.
16 studies in Sarcoma by Fred Hutchinson Cancer Center: none open now, none under way, none of them phase 3. Of 14 finished, 3 (21%) have results posted.
Among the 16 studies in Sarcoma by Fred Hutchinson Cancer Center, this one is the 4th largest by enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2018, is one of 4 in phase 1/2, and was the 12th registered.
Fred Hutchinson Cancer Center’s Sarcoma studies by the year they started, since 1998.
3 of the studies testing pembrolizumab in Sarcoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05182164Institut BergoniéCombination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas | 2026-12 |
| NCT05679921Yonsei UniversityPazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma | 2026-12-31 |
| NCT04332874Memorial Sloan Kettering Cancer CenterA Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg | 2027-04-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 20 studies testing pembrolizumab in Sarcoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Fred Hutchinson Cancer Center’s 16 in Sarcoma:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This phase I/II trial studies pembrolizumab and radiation therapy in treating patients with intermediate or high-grade soft tissue sarcoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy may work better in treating patients with soft tissue sarcoma.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) per institutional standard at the Seattle Cancer Care Alliance as an outpatient therapy. Cycles repeat every 3 weeks, up to a maximum of three doses, for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks beginning on Day 1 of Week 2.
After completion of study treatment, patients are followed up at 30 days after last dose, 90 days after last dose, 30 days after post-operative visit (wound care follow-up), and then every 12 weeks for up to 1 year, then every 6 months up to 5 years.
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.
Have newly diagnosed disease or localized recurrent or oligometastatic lesions that are candidates for radiation
>= 9 g/dL or >= 5.6 mmol/L (performed within 28 days of enrollment)
* Criteria must be met without erythropoeiten dependency and without packed red blood cell (pRBC) transfusion within last two weeks
Serum creatinine =\< 1.5 X (ULN) OR measured or calculated ( [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (performed within 28 days of enrollment)
* Creatinine clearance should be calculated per institutional standard
Exclusion Criteria:
Has one of the following sarcoma subtypes where chemotherapy is established as practice at our institution: extra-skeletal Ewing's sarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma
* NOTE: Pleomorphic rhabdomyosarcoma is allowed. Bone sarcomas including osteosarcoma, Ewing's sarcoma and chondrosarcoma are not allowed. Extra-skeletal Osteosarcoma is considered a soft tissue sarcoma and is allowed.
Has a history of a second , unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
* NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers
Has current or a history of any distant disease (including brain)
*NOTE: An isolated or oligo-metastatic regional recurrence may be allowed if all other criteria are met, curative attempt is being pursued
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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 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.
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 that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
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.
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.
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.
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for 3 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy daily for 5-6 weeks.
Biological: Pembrolizumab · Radiation: Radiation Therapy
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Undergo radiation therapy
Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, NOS, Energy Type
Rate of Complete Tumor Necrosis
Necrosis greater than or equal to 90% at pathologic assessment at time of surgery
Time frame: From baseline through wound care follow-up visit (up to 8 months)
Incidence of Adverse Events
Treatment-related adverse events (AEs) experienced by participants evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and determined to be possibly related, probably related, or definitely related to either pembrolizumab therapy, radiation therapy, or both.
Time frame: Through the wound care follow-up visit (up to 8 months)
Partial Response Rate
Proportion of patients who achieved a partial response based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
Time frame: From baseline through wound care follow-up visit (up to 8 months)
Complete Response Rate
Rate of disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm as defined per RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
Time frame: From baseline through wound care follow-up visit (up to 8 months)
Overall Response Rate
Rate of participants who experienced a Complete Response (CR) + Partial Reponse (PR) as defined per RECIST v1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
Time frame: From baseline through wound care follow-up visit (up to 8 months)
| Milestone | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Started | 27 |
| Completed | 9 |
| Not completed | 18 |
| Withdrew: Patients remain in long-term follow-up | 17 |
| Withdrew: Physician decision | 1 |
Necrosis greater than or equal to 90% at pathologic assessment at time of surgery
| Participants | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Rate of Complete Tumor Necrosis | 4 |
Treatment-related adverse events (AEs) experienced by participants evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and determined to be possibly related, probably related, or definitely related to either pembrolizumab therapy, radiation therapy, or both.
| events experienced | Grade 1 Events | Grade 2 Events | Grade 3 Events | Grade 4 Events | Grade 5 Events |
|---|---|---|---|---|---|
| Dermatitis Radiation | 12 | 7 | 0 | 0 | 0 |
| Fatigue | 11 | 3 | 0 | 0 | 0 |
| Rash maculo-papular | 5 | 3 | 0 | 0 | 0 |
| Diarrhea | 5 | 1 | 0 | 0 | 0 |
| Tumor pain | 2 | 2 | 0 | 0 | 0 |
| Lymphocyte count decreased | 0 | 3 | 1 | 0 | 0 |
| Wound dehiscence | 2 | 1 | 1 | 0 | 0 |
| Hypothyroidism | 0 | 4 | 0 | 0 | 0 |
| Nausea | 1 | 2 | 0 | 0 | 0 |
| Pain in extremity | 1 | 1 | 0 | 0 | 0 |
| Anorexia | 1 | 1 | 0 | 0 | 0 |
| Edema limbs | 2 | 0 | 0 | 0 | 0 |
| Anemia | 0 | 1 | 1 | 0 | 0 |
| Bullous dermatitis | 2 | 0 | 0 | 0 | 0 |
| Skin and subcutaneous disorders - Other - Erythema | 2 | 0 | 0 | 0 | 0 |
| Dizziness | 1 | 0 | 0 | 0 | 0 |
| Alanine aminotransferase increased | 0 | 1 | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 0 | 0 | 1 | 0 | 0 |
| Pneumothorax | 1 | 0 | 0 | 0 | 0 |
| Dry skin | 1 | 0 | 0 | 0 | 0 |
| Pruritus | 0 | 1 | 0 | 0 | 0 |
| Dehydration | 0 | 1 | 0 | 0 | 0 |
| Weight loss | 1 | 0 | 0 | 0 | 0 |
| Peripheral sensory neuropathy | 1 | 0 | 0 | 0 | 0 |
| Cough | 1 | 0 | 0 | 0 | 0 |
| Hypokalemia | 1 | 0 | 0 | 0 | 0 |
| Peripheral ischemia | 0 | 0 | 0 | 1 | 0 |
| Chest wall pain | 0 | 1 | 0 | 0 | 0 |
| Blood and lymphatic system disorders - Other - Eosinophil count increased | 1 | 0 | 0 | 0 | 0 |
| Thyroid Stimulating Hormone Increased | 1 | 0 | 0 | 0 | 0 |
| Rectal pain | 1 | 0 | 0 | 0 | 0 |
| Wound infection | 0 | 0 | 1 | 0 | 0 |
| Localized edema | 1 | 0 | 0 | 0 | 0 |
| Urinary urgency | 1 | 0 | 0 | 0 | 0 |
| Pelvic pain | 1 | 0 | 0 | 0 | 0 |
| Urinary retention | 0 | 1 | 0 | 0 | 0 |
| Neuralgia | 1 | 0 | 0 | 0 | 0 |
| Thromboembolic event | 0 | 1 | 0 | 0 | 0 |
| Hypomagnesemia | 1 | 0 | 0 | 0 | 0 |
| Vaginal hemorrhage | 0 | 0 | 1 | 0 | 0 |
| Colitis | 0 | 1 | 0 | 0 | 0 |
| Skin and subcutaneous disorders - Other - Rash | 1 | 0 | 0 | 0 | 0 |
Proportion of patients who achieved a partial response based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
| proportion of participants | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Partial Response Rate | 0.08 (0.01 to 0.25) |
Rate of disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm as defined per RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
| proportion of participants | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Complete Response Rate | 0.00 (0.00 to 0.13) |
Rate of participants who experienced a Complete Response (CR) + Partial Reponse (PR) as defined per RECIST v1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
| proportion of participants | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Overall Response Rate | 0.08 (0.01 to 0.25) |
Collected over All adverse events will be recorded from the day informed consent is signed through the Wound Care Follow-Up visit (e.g. up to 8 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Pembrolizumab, Radiation Therapy) | 0/27 (0%) | 5/27 (18.5%) | 17/27 (63%) |
| Event | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Abdominal PainGastrointestinal disorders | 2/27 |
| Wound infectionInfections and infestations | 2/27 |
| Aspartate aminotransferase increasedInvestigations | 1/27 |
| Colonic perforationGastrointestinal disorders | 1/27 |
| DeliriumPsychiatric disorders | 1/27 |
| Gastrointestinal disorders - OtherGastrointestinal disorders | 1/27 |
| HallucinationsPsychiatric disorders | 1/27 |
| Lung infectionRespiratory, thoracic and mediastinal disorders | 1/27 |
| NauseaGastrointestinal disorders | 1/27 |
| Peripheral ischemiaVascular disorders | 1/27 |
| Event | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| FatigueGeneral disorders | 17/27 |
| Dermatitis RadiationInjury, poisoning and procedural complications | 14/27 |
| DiarrheaGastrointestinal disorders | 11/27 |
| NauseaGastrointestinal disorders | 9/27 |
| AnorexiaGastrointestinal disorders | 8/27 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 6/27 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 5/27 |
| ConstipationGastrointestinal disorders | 5/27 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/27 |
| HypomagnesemiaMetabolism and nutrition disorders | 5/27 |
| Age, Customized(Participants) | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Aged Under 18 at Enrollment | 0 |
| Aged 18-29 at Enrollment | 1 |
| Aged 30-39 at Enrollment | 1 |
| Aged 40-49 at Enrollment | 2 |
| Aged 50-59 at Enrollment | 4 |
| Aged 60-69 at Enrollment | 9 |
| Aged 70 and Above at Enrollment | 10 |
| Sex: Female, Male(Participants) | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Female | 14 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 25 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Treatment (Pembrolizumab, Radiation Therapy) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 1 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Jun 2023, 62 months.
Results were first posted in Jul 2024, 1 year 1 month after primary completion.
Of 57 non-industry phase 1/2 interventional studies under Sarcoma, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 51 and three quarters within 117. This study's 62 months is below that.
Counting every sponsor, half of 101 studies reached it within 62 months; a quarter within 45 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab
Fred Hutchinson Cancer Center →