ClinicalTrials.gg
Active, not recruitingNCT04417660Updated Oct 16, 2026

Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma

A Phase 2 interventional study of M7824 in Thymic Epithelial Tumor, Recurrent Thymoma and Thymic Cancer, sponsored by National Cancer Institute (NCI). Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Background:

Thymoma and thymic carcinoma are diseases of the thymus. Platinum-based chemotherapy is the standard treatment for these diseases. But in many cases, the disease returns after treatment. Researchers want to see if a new drug can help.

Objective:

To see if bintrafusp alfa (M7824) is an effective treatment for thymoma and thymic carcinoma.

Eligibility:

People age 18 and older who have thymoma or thymic cancer and their disease returned or progressed after treatment with at least one platinum-containing chemotherapy treatment plan.

Design:

Participants will be screened under a separate protocol. Their medical, medicine, and treatment history will be reviewed. They will have a tumor biopsy if they do not have a sample.

Participants will get the study drug once every 2 weeks as an intravenous infusion. For this, a small plastic tube is put into an arm vein.

During the study, participants will undergo the following:

Medicine review

Physical exam

Review of their symptoms and their ability to perform their normal activities

Blood and urine tests

Thigh muscle scan (using MRI)

Tumor assessment (using MRI or CT)

Heart and lung function tests

Thyroid gland test

Skin assessment.

Participants may have tumor biopsies. Some of their blood and biopsy samples will be used for gene testing.

Participants may take the study drug until their disease worsens or they cannot tolerate treatment.

Participants will have follow-up visits 2 and 6 weeks after stopping treatment. Then they will have long-term follow-up visits every 3 months. These may include imaging scans. Visits may be done by phone, with scans (if needed) done at their doctor's office.

Read the detailed description

Background

Platinum-based chemotherapy is the standard of care for advanced unresectable thymic epithelial tumors (TETs). However more than half of these patients experience disease recurrence and require second-line therapy.

There are no approved drugs for treatment of recurrent thymoma and thymic carcinoma and new therapeutic options are needed for patients who have disease progression on or after platinum-containing therapy.

We have demonstrated the safety and clinical activity of immune checkpoint inhibition in patients with recurrent TETs. In an ongoing trial (NCT03076554) we have shown that avelumab, an anti-programmed death ligand-1 (PD-L1) antibody, induces major responses and has an acceptable safety profile.

Combination immunotherapy is under evaluation for treatment of various cancers but has not been studied for the treatment of TETs. Immunotherapy targeting the PD-1/PD-L1 axis can be combined with other immune checkpoint inhibitors, cancer vaccines and anti-cytokine therapy.

Bintrafusp alfa, a bifunctional fusion protein that targets PD-L1 and transforming growth factor-Beta (TGF-Beta) has shown activity against heavily pre-treated solid tumors including non-small cell lung cancer previously treated with single-agent anti-PD-1/PD-L1 inhibitors.

Retrospective analysis of pre-chemotherapy tissue obtained from 20 patients with stage IV thymic carcinoma and 13 cases of stage III/IV thymoma, showed TGF-Beta expression in 65% cases of thymic carcinoma and 15% cases of thymoma with a lower median survival among patients with thymic carcinoma (30 months versus 63 months).

As part of a phase I clinical trial, treatment with bintrafusp alfa resulted in a brief period of disease stabilization and no immune-related adverse events in one patient with heavily pre-treated, WHO subtype B3 thymoma with a large disease burden

Further investigation of Bintrafusp alfa in patients with recurrent TETs is needed to define the clinical activity and safety of this drug in patients with TETs.

Primary Objectives

To determine the objective response rate (ORR) to bintrafusp alfa in participants with relapsed or refractory thymoma and thymic carcinoma.

Eligibility

Participants >= age 18 years with histologically confirmed, unresectable thymoma or thymic carcinoma who have previously been treated with at least one platinum-containing chemotherapy regimen with progressive disease prior to study entry.

Progressive and measurable disease prior to enrollment

No history of autoimmune disease, with exception of vitiligo, autoimmune thyroid disease, or pure red cell aplasia that are adequately managed with medical therapy

Adequate renal, hepatic and hematopoietic function

Design

This will be a single-arm, phase II study to determine the clinical activity of treatment with Bintrafusp alfa in participants with relapsed or refractory thymoma and thymic carcinoma.

Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until disease progression or development of intolerable adverse events. The two-week period will constitute one cycle.

A Simon optimal two-stage phase II trial design will be used to rule out unacceptably low response rate of 20% in favor of an improved response rate of 45%

Participants will be enrolled in 2 disease cohorts, thymoma and thymic carcinoma, with up to 17 evaluable participants of each tumor type. Accrual ceiling will be set at 44 participants to account for inevaluable participants and screen failures.

Participants who have completed 12 months of treatment with an ongoing response or disease stability (for >= 6 months) will be given an option of discontinuing active treatment with the ability to reinstitute treatment on one occasion if radiological or clinical disease activity is noted during follow-up. All eligibility criteria should be met at the time of restarting treatment with bintrafusp alfa.

Tumor response will be assessed after completion of every third cycle (6 weeks) using modified immune-related RECIST criteria. When possible, an optional tumor biopsy will be conducted pre-treatment, after 3 doses in participants responding to treatment or at 6 weeks, whichever is sooner, to evaluate treatment-related, intra-tumoral changes.

Exploratory objectives include immune correlative studies to analyze immune cell subsets, PD-L1 expression and evaluation of soluble factors and intra-tumoral changes before and after bintrafusp alfa treatment.

02

Conditions studied

  • Thymic Epithelial Tumor
  • Recurrent Thymoma
  • Thymic Cancer

Keywords

  • Thymoma
  • thymic cancer
  • Immune Checkpoint Inhibition
  • programmed death ligand 1 (PD-L1)
03

In context

Thymic epithelial tumor

26 studies on the registry are indexed under Thymic epithelial tumor; 19 are open to participants now.

This study's enrollment of 9 is below the median of 48 across 19 interventional studies indexed under Thymic epithelial tumor.

Browse Thymic epithelial tumor 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

  • IINCLUSION CRITERIA:
  • Participants must have confirmed (by the pathology department/CCR/NCI) thymoma or thymic carcinoma.
  • Participants must have had at least one prior line of platinum-based chemotherapy. Progressive disease must be documented prior to study entry and participants must have advanced, unresectable disease that is not amenable to surgical resection.
  • Disease must be measurable with at least 1 unidimensional by RECIST1.1.
  • Participants must be aged >=18 years.
  • performance status \<=1.
  • Participants must have adequate organ and marrow function as defined below:

    • : >= 1,500/mm\^3 OR >= 1.5 x 10\^9/L
    • : >=> 100,000/mm\^3 OR >= 100 x 10\^9/L
    • : >= 9g/dL (may have been transfused)
    • total : \<= the (ULN) OR \<= 3.0 x ULN for participants with documented disease to the liver
    • (SGOT)/ALT(SGPT): \<= 1.5 x ULN OR \<= 5 x ULN for participants with documented metastatic disease to the liver
    • ALP: \<= 2.5 x ULN
    • : >= 60 mL/min/1.73 m\^2 calculated by calculated using eGRF in the clinical lab
    • : normal INR, per institutional guidelines
    • PT: \<= 1.5 x ULN
    • aPTT: \<= 1.5 x ULN
  • Negative serum or urine pregnancy test at screening for individuals of (IOCBP). NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not . If necessary, to confirm postmenopausal status an FSH level will be included at screening. The effects of Bintrafusp alfa on the developing human fetus are unknown. For this reason, individuals of childbearing potential and those that can father children must agree to use adequate (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for at least 2 months after the last dose of the drug.
  • Participants with previously treated brain or are eligible provided that the participant has recovered from any acute side effects of radiotherapy and does not require treatment with , and any whole brain radiation therapy was completed at least 2 weeks prior to enrollment.
  • Ability of participant to understand and the willingness to sign a written document.

EXCLUSION CRITERIA:

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bintrafusp alfa.
  • History of anaphylaxis or recent (within 5 months) history of uncontrollable asthma.
  • Prior treatment with or PD-L1-directed immune checkpoint blockade is not permitted. Prior treatment with other immunomodulating drugs such as cancer vaccines is permitted based on investigators' discretion as long as treatment was not discontinued due to life-threatening adverse events (laboratory abnormalities alone with prior therapy will not exclude participants from this trial).
  • Concurrent treatment with a non-permitted drug
  • Prior anticancer treatment within 14 days before treatment (e.g., cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin); major surgery within 14 days before treatment (excluding prior diagnostic ); prior systemic therapy (or 5 half-lives of a drug, whichever is shorter) with agents within 14 days before treatment; use of hormonal agents for anti-cancer therapy within 7 days before treatment; or use of any drug within 14 days before treatment.

Note: Participants receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before treatment.

  • History of previous malignant disease within the last 3 years with the following exceptions: basal or squamous cell carcinoma in situ of the skin treated with curative intent, endoscopically resected GI cancers limited to the mucosal layer without recurrence in > 1 year, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary or follicular thyroid carcinoma, and superficial/non-muscle invasive bladder cancer.
  • Active brain or CNS metastases causing clinical symptoms or metastases that require therapeutic intervention.
  • Active or history of disease that might deteriorate when receiving an immune-stimulatory agent, with the exception of diabetes type I, vitiligo, psoriasis, autoimmune thyroid disease not requiring immunosuppressive treatment, or pure red cell aplasia that are adequately managed with medical therapy. In addition, anti-acetylcholine receptor binding antibodies will be checked during screening and participants will be ineligible if results are positive, even if there is no clinical history of autoimmune disease.
  • Participants receiving systemic corticosteroids at doses > 10 mg daily prednisone equivalent will be excluded. However, participants on inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of autoimmune disease
  • Active infection requiring systemic therapy or significant acute or chronic infections including, among others:

    • virus (HBV) or virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
    • Known history of testing positive for or testing positive for HIV at screening or known acquired immunodeficiency syndrome.

HIV-positive TET participants are ineligible because of the risk of developing opportunistic infections after treatment with an immune checkpoint inhibitor. Additionally, TET participants are at higher risk of developing opportunistic infections due to underlying immune defects. Prior cases of disseminated herpes virus, cytomegalovirus and fungal infections have been documented in this patient population.

  • Prior organ transplantation including allogenic stem-cell transplantation, Participants who have had prior transplants that do not require immunosuppression are eligible.
  • Persisting toxicity related to prior therapy ( v. 5 Grade > 1); however, alopecia, sensory neuropathy Grade \<= 2, or other Grade \<= 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • Participants unwilling to accept blood products as medically indicated.
  • Pregnant or lactating individuals. Pregnant individuals are excluded from this study because Bintrafusp alfa is in the class of agents known as antineoplastics/monoclonal antibodies with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Bintrafusp alfa, breastfeeding should be discontinued if the mother is treated with Bintrafusp alfa.
  • Known alcohol or drug abuse.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, cerebral vascular accident/stroke \< 6 months prior to enrollment, myocardial infarction \< 6 months prior to enrollment, or psychiatric illness/social situations that would limit compliance with study requirements. All other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, drug-induced pneumonitis requiring oral or IV steroids, interstitial lung disease, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the individual inappropriate for entry into this study. Participants with history of bleeding diathesis or recent major bleeding events considered by the Investigator as high risk for investigational drug treatment are also excluded.
  • Administration of within 4 weeks prior to treatment, with the exception of vaccination against COVID-19
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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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.

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.

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).

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.

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.

Metastases

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Bintrafusp alfa (M7824)

    Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until disease progression or development of intolerable adverse events.

    Drug: M7824

Interventions

  • DrugM7824

    Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until disease progression or development of intolerable adverse events.

06

What researchers measure

Primary outcomes

  1. Objective response rate

    overall response rate for M7824 based on RECIST criteria

    Time frame: from the start of the treatment until disease progression/recurrence

Secondary outcomes

  1. Duration of response, progression free survival &amp; overall survival

    To determine duration of response, progression free survival and overall survival in participants with recurrent thymic epithelial TETs

    Time frame: from the start of the treatment until disease progression/recurrence

  2. Safety &amp; tolerability of M7824

    To determine the safety and tolerability of 1200 mg M7824 administered once every 2 weeks in participants with thymoma and thymic carcinoma

    Time frame: from the start of the treatment until disease progression/recurrence

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20. PubMed 34393061 ↗

Individual participant data

Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.

Access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2020 (actual). Primary completion is estimated for Dec 2026, 72 months after the start.

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

Registered
Jun 4, 2020
First posted
Jun 5, 2020
StartActual
Dec 26, 2020
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jul 1, 2027
Last update
Oct 16, 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.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 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
NCT04417660
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
Dec 26, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Arun Rajan, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

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

Not currently enrolling

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Studies of the drug tested here: Bintrafusp alfa

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