ClinicalTrials.gg
RecruitingNCT06422806Updated Nov 6, 2026

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas

A Phase 3 interventional study of Biospecimen Collection and Diagnostic Imaging Testing in Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma and Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by National Cancer Institute (NCI). Recruiting at 269 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Updated Nov 6, 2026Site recruiting status changed9 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
365
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.

II. To assess whether the combination of doxorubicin and pembrolizumab will improve PFS in DDLPS relative to doxorubicin alone.

KEY SECONDARY OBJECTIVE:

I. To assess whether the combination of doxorubicin and pembrolizumab versus (vs) the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS) in DDLPS and the UPS family of diseases.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability in each treatment arm. II. To quantify overall response rate (ORR) and durability of response (DOR) in each treatment.

EXPLORATORY OBJECTIVES:

I. To evaluate the agreement between the central review and local Response Evaluation Criteria in Solid Tumors (RECIST) assessments for patients identified for central imaging review.

II. To compare PFS, OS, ORR and DOR of doxorubicin with or without pembrolizumab for all patients, combining the UPS and DDLPS patients together.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive doxorubicin intravenously (IV) over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity.

Patients in both arms also undergo echocardiography (ECHO) or multigated acquisition (MUGA) scan, standard imaging scans and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months in years 2-10.

02

Conditions studied

  • Metastatic Dedifferentiated Liposarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Unresectable Dedifferentiated Liposarcoma
  • Unresectable Undifferentiated Pleomorphic Sarcoma
03

In context

Liposarcoma

160 studies on the registry are indexed under Liposarcoma; 36 are open to participants now.

This study's planned enrollment of 365 is above the median of 52 across 136 interventional studies indexed under Liposarcoma.

Browse Liposarcoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patient must be >= 18 years of age
  • Patient must have a confirmed histopathologic diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to:

    • Pleomorphic sarcoma with inflammation or with limited areas of differentiation
    • Pleomorphic sarcoma with giant cells
    • Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
    • Myxofibrosarcoma
    • Poorly differentiated sarcoma not otherwise specified (NOS)
    • Undifferentiated spindle cell sarcoma
    • Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have areas of focal myogenic differentiation
  • Patient must have or unresectable sarcoma
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:

    • Has achieved menarche at some point
    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patient must not expect to conceive or father children by using an accepted and effective method(s) of or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 6 months after the last dose of doxorubicin for patients of child bearing potential and for 3 months after the last dose of doxorubicin for male patients with partners of child bearing potential. Males with pregnant partners should use condoms during doxorubicin treatment and for at least 10 days after the last dose of doxorubicin. Contraception measures must also continue for 4 months after the last dose of pembrolizumab for patients of child bearing potential
  • Patient must have the ability to understand and the willingness to sign a written document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Patient must have a (LVEF) > 50% by either MUGA scan or echocardiogram obtained within 28 days prior to randomization
  • (ANC) ≥ 1,500 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
  • ≥ 75,000 cells/uL (must be obtained ≤ 7 days prior to protocol randomization)
  • Total \< 1.2 mg/dL (must be obtained ≤ 7 days prior to protocol randomization)
  • (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 × institutional (ULN) (must be obtained ≤ 7 days prior to protocol randomization)
  • ≥ 30 mL/min according to the Cockcroft-Gault formula (must be obtained ≤ 7 days prior to protocol randomization)
  • (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • For patients with evidence of chronic virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  • Patients with new or progressive brain metastases (active brain metastases) or are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
  • Patients with a prior or concurrent whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patient must not have a history of or active interstitial lung disease
  • Patient must have . Baseline imaging must include a chest computed tomography (CT). Imaging should be inclusive of all measurable and non-measurable disease and must be obtained within 28 days prior to randomization. Imaging must be available for uploading to Transfer of Images and Data (TRIAD)

    • NOTE: CT with (w/) contrast preferred, chest CT without contrast is acceptable, CT portion of positron emission tomography (PET) may be acceptable. Magnetic resonance imaging (MRI) is acceptable for measuring other sites of disease
  • Patient must have an (ECOG) performance status 0-1
  • Patient must not have had prior treatment with an anthracycline
  • Patient must not have a diagnosis of immunodeficiency or an disorder requiring the patient to use systemic chronically, or systemic steroids within 7 days prior to randomization
  • Patient must not have a known history of active TB (Bacillus Tuberculosis)
  • Patient must not have a known to doxorubicin or pembrolizumab or any of their
  • Patients who have received prior chemotherapy, targeted small molecule therapy or radiation therapy must have recovered from the prior therapy at the time of randomization
  • Patient must have recovered adequately from any prior major surgery prior to randomization
  • Patient must not have had prior pericardial or mediastinal radiation
  • Patient must not have received prior therapy with an , anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent
  • Patient must not have an autoimmune or other disease that requires the use of daily corticosteroids of > 10 mg of prednisone (or equivalent). Patients who are on an active steroid taper at the time of randomization must finish prior to beginning study treatment. Patients who require inhaled or topical steroids are eligible
Terms in these criteria, in plain language(28)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

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.

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.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
365 participants (estimated)

Study arms

  • Experimental
    Arm A (doxorubicin and pembrolizumab

    Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan, standard imaging scans and blood sample collection throughout the study.

    Procedure: Biospecimen Collection · Procedure: Diagnostic Imaging Testing · Drug: Doxorubicin · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Biological: Pembrolizumab

  • Active comparator
    Arm B (doxorubicin)

    Patients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan, standard imaging scans and blood sample collection throughout the study.

    Procedure: Biospecimen Collection · Procedure: Diagnostic Imaging Testing · Drug: Doxorubicin · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureDiagnostic Imaging Testing

    Undergo standard imaging scans

    Also known as: Diagnostic Imaging, Medical Imaging

  • Given IV

    Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • ProcedureMultigated Acquisition Scan

    Undergo MUGA scan

    Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

  • BiologicalPembrolizumab

    Given IV

    Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Will be compared between the treatment arms (doxorubicin + pembrolizumab versus \[vs\] doxorubicin alone). The comparison of PFS between treatment arms will be done using a stratified (on Eastern Cooperative Oncology group performance status \[0 vs 1\]) log-rank test with a 2.5% type I error (1-sided). Will be analyzed separately for the undifferentiated pleomorphic sarcoma and related malignancies and for the dedifferentiated liposarcoma.

    Time frame: From randomization to documented progression (per Response Evaluation Criteria in Solid Tumors version 1.1) or death from any cause without prior progression, up to 5 years

Secondary outcomes

  1. Overall survival

    Will be compared between doxorubicin + pembrolizumab vs doxorubicin alone to test the strategy of upfront pembrolizumab vs second line pembrolizumab.

    Time frame: From randomization to death, up to 5 years

Other outcomes

  1. Progression status

    Evaluated using Cohen's kappa coefficient.

    Time frame: From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years

  2. Progression time

    Time frame: From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years

07

Study locations

247 of 269 sites recruiting

Showing the first 100 of 269 sites across 3 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Data sharing details ↗ · grants.nih.gov

No publications or documents are linked to this record.

09

Timeline

11 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Apr 2032, 91 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2024
First posted
May 21, 2024
StartActual
Sep 11, 2024
Primary completionEst.
Apr 18, 2032
CompletionEst.
Apr 18, 2032
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
9 sites added. 20 sites changed recruiting status (14 now suspended, 3 now active, not recruiting, …)
Show 20 sites
  • Elmhurst Memorial Hospital · Elmhurst, United StatesRecruiting→Active, not recruiting
  • Edward Hospital/Cancer Center · Naperville, United StatesRecruiting→Active, not recruiting
  • Edward Hospital/Cancer Center?Plainfield · Plainfield, United StatesRecruiting→Active, not recruiting
  • Upper Valley Medical Center · Troy, United StatesSuspended→Recruiting
  • Oregon Health and Science University · Portland, United StatesSuspended→Recruiting
  • Allegheny General Hospital · Pittsburgh, United StatesSuspended→Recruiting
  • Illinois CancerCare-Bloomington · Bloomington, United StatesRecruiting→Suspended
  • Illinois CancerCare-Canton · Canton, United StatesRecruiting→Suspended
  • Illinois CancerCare-Carthage · Carthage, United StatesRecruiting→Suspended
  • Illinois CancerCare-Dixon · Dixon, United StatesRecruiting→Suspended
  • Illinois CancerCare-Eureka · Eureka, United StatesRecruiting→Suspended
  • Illinois CancerCare-Galesburg · Galesburg, United StatesRecruiting→Suspended
  • Illinois CancerCare-Kewanee Clinic · Kewanee, United StatesRecruiting→Suspended
  • Illinois CancerCare-Macomb · Macomb, United StatesRecruiting→Suspended
  • Illinois CancerCare-Ottawa Clinic · Ottawa, United StatesRecruiting→Suspended
  • Illinois CancerCare-Pekin · Pekin, United StatesRecruiting→Suspended
  • Illinois CancerCare-Peoria · Peoria, United StatesRecruiting→Suspended
  • Illinois CancerCare-Peru · Peru, United StatesRecruiting→Suspended
  • Illinois CancerCare-Princeton · Princeton, United StatesRecruiting→Suspended
  • Illinois CancerCare - Washington · Washington, United StatesRecruiting→Suspended
Show 9 added (9 United States)
  • Essentia Health Cancer Center-South University Clinic · Fargo, United States
  • Saint Vincent Hospital · Erie, United States
  • Jefferson Hospital · Jefferson Hills, United States
  • Forbes Hospital · Monroeville, United States
  • West Penn Hospital · Pittsburgh, United States
  • Wexford Health and Wellness Pavilion · Wexford, United States
  • AdventHealth Orlando · Orlando, United States
  • Marshfield Medical Center-Rice Lake · Rice Lake, United States
  • Minnesota Oncology - Edina · Edina, United States
across 8 updates, Oct 1, 2026 – Nov 6, 2026
Site contacts
Changed at 22 sites. See the sites
Show 22 sites
  • Elmhurst Memorial Hospital · Elmhurst, United StatesContact removed J•••@emhc.org · •••5460Contact removed (no phone or email listed)
  • Edward Hospital/Cancer Center · Naperville, United StatesContact removed •••6075Contact removed (no phone or email listed)
  • Edward Hospital/Cancer Center?Plainfield · Plainfield, United StatesContact removed C•••@edward.org · •••6075Contact removed (no phone or email listed)
  • Upper Valley Medical Center · Troy, United StatesContact added c•••@daytonncorp.org · •••2900Contact added (no phone or email listed)
  • Cross Cancer Institute · Edmonton, CanadaContact person changed (no phone or email listed)
  • Oregon Health and Science University · Portland, United StatesContact added t•••@ohsu.edu · •••1080Contact added (no phone or email listed)
  • Allegheny General Hospital · Pittsburgh, United StatesContact added •••2000Contact added (no phone or email listed)
  • UT MD Anderson Cancer Center · Houston, United StatesContact person changed (no phone or email listed)
  • Illinois CancerCare-Bloomington · Bloomington, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Canton · Canton, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Carthage · Carthage, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Dixon · Dixon, United StatesContact removed •••7800Contact removed (no phone or email listed)
  • Illinois CancerCare-Eureka · Eureka, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Galesburg · Galesburg, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Kewanee Clinic · Kewanee, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Macomb · Macomb, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Ottawa Clinic · Ottawa, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Pekin · Pekin, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Peoria · Peoria, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Peru · Peru, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare-Princeton · Princeton, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  • Illinois CancerCare - Washington · Washington, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
across 6 updates, Oct 1, 2026 – Nov 6, 2026
Show all 11 updates
  1. Nov 6, 2026
    14 sites changed recruiting status (14 now suspended)
    Show 14 sites
    • Illinois CancerCare-Bloomington · Bloomington, United StatesRecruiting→Suspended
    • Illinois CancerCare-Canton · Canton, United StatesRecruiting→Suspended
    • Illinois CancerCare-Carthage · Carthage, United StatesRecruiting→Suspended
    • Illinois CancerCare-Dixon · Dixon, United StatesRecruiting→Suspended
    • Illinois CancerCare-Eureka · Eureka, United StatesRecruiting→Suspended
    • Illinois CancerCare-Galesburg · Galesburg, United StatesRecruiting→Suspended
    • Illinois CancerCare-Kewanee Clinic · Kewanee, United StatesRecruiting→Suspended
    • Illinois CancerCare-Macomb · Macomb, United StatesRecruiting→Suspended
    • Illinois CancerCare-Ottawa Clinic · Ottawa, United StatesRecruiting→Suspended
    • Illinois CancerCare-Pekin · Pekin, United StatesRecruiting→Suspended
    • Illinois CancerCare-Peoria · Peoria, United StatesRecruiting→Suspended
    • Illinois CancerCare-Peru · Peru, United StatesRecruiting→Suspended
    • Illinois CancerCare-Princeton · Princeton, United StatesRecruiting→Suspended
    • Illinois CancerCare - Washington · Washington, United StatesRecruiting→Suspended
    Site contacts Changed at 14 sites. See the sites
    Show 14 sites
    • Illinois CancerCare-Bloomington · Bloomington, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Canton · Canton, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Carthage · Carthage, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Dixon · Dixon, United StatesContact removed •••7800Contact removed (no phone or email listed)
    • Illinois CancerCare-Eureka · Eureka, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Galesburg · Galesburg, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Kewanee Clinic · Kewanee, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Macomb · Macomb, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Ottawa Clinic · Ottawa, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Pekin · Pekin, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Peoria · Peoria, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Peru · Peru, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare-Princeton · Princeton, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
    • Illinois CancerCare - Washington · Washington, United StatesContact removed a•••@illinoiscancercare.com · •••3605Contact removed (no phone or email listed)
  2. Oct 26, 2026
    1 site added
    Show site
    • Minnesota Oncology - Edina · Edina, United States
  3. Oct 23, 2026
    1 site added
    Show site
    • Marshfield Medical Center-Rice Lake · Rice Lake, United States
  4. Oct 22, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • UT MD Anderson Cancer Center · Houston, United StatesContact person changed (no phone or email listed)
  5. Oct 20, 2026
    1 site added
    Show site
    • AdventHealth Orlando · Orlando, United States
  6. Oct 15, 2026
    5 sites added. 2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Oregon Health and Science University · Portland, United StatesSuspended→Recruiting
    • Allegheny General Hospital · Pittsburgh, United StatesSuspended→Recruiting
    Show 5 added (5 United States)
    • Saint Vincent Hospital · Erie, United States
    • Jefferson Hospital · Jefferson Hills, United States
    • Forbes Hospital · Monroeville, United States
    • West Penn Hospital · Pittsburgh, United States
    • Wexford Health and Wellness Pavilion · Wexford, United States
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Oregon Health and Science University · Portland, United StatesContact added t•••@ohsu.edu · •••1080Contact added (no phone or email listed)
    • Allegheny General Hospital · Pittsburgh, United StatesContact added •••2000Contact added (no phone or email listed)
  7. Oct 13, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Cross Cancer Institute · Edmonton, CanadaContact person changed (no phone or email listed)
  8. Oct 7, 2026
    Upper Valley Medical Center is now Recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Upper Valley Medical Center · Troy, United StatesContact added c•••@daytonncorp.org · •••2900Contact added (no phone or email listed)
  9. Oct 5, 2026
    1 site added
    Show site
    • Essentia Health Cancer Center-South University Clinic · Fargo, United States
  10. Oct 1, 2026
    3 sites changed recruiting status (3 now active, not recruiting)
    Show 3 sites
    • Elmhurst Memorial Hospital · Elmhurst, United StatesRecruiting→Active, not recruiting
    • Edward Hospital/Cancer Center · Naperville, United StatesRecruiting→Active, not recruiting
    • Edward Hospital/Cancer Center?Plainfield · Plainfield, United StatesRecruiting→Active, not recruiting
    Site contacts Changed at 3 sites. See the sites
    Show 3 sites
    • Elmhurst Memorial Hospital · Elmhurst, United StatesContact removed J•••@emhc.org · •••5460Contact removed (no phone or email listed)
    • Edward Hospital/Cancer Center · Naperville, United StatesContact removed •••6075Contact removed (no phone or email listed)
    • Edward Hospital/Cancer Center?Plainfield · Plainfield, United StatesContact removed C•••@edward.org · •••6075Contact removed (no phone or email listed)
  11. Sep 30, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06422806
Responsible party
Sponsor
First posted
May 21, 2024
Start date
Sep 11, 2024
Primary completion
Apr 18, 2032 (estimated)
Completion
Apr 18, 2032 (estimated)
Last update
Nov 6, 2026

Study contacts

Seth M Pollack
principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Pembrolizumab

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