Thymic Epithelial TumorPhase 2NCT04417660
Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
A Phase 2 study testing M7824 in people with Thymic Epithelial Tumor and Recurrent Thymoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymic Epithelial Tumor, Recurrent Thymoma, Thymic Cancer
- What is being tested?
- M7824
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2020to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 PD-1 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 biopsy); prior systemic therapy (or 5 half-lives of a drug, whichever is shorter) with immunosuppressive agents within 14 days before treatment; use of hormonal agents for anti-cancer therapy within 7 days before treatment; or use of any investigational drug within 14 days before treatment.
- Note: Participants receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before treatment.
Show all 21Show fewer
- 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 autoimmune 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:
- Hepatitis B virus (HBV) or hepatitis C 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 HIV 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 (NCI CTCAE 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 live vaccine within 4 weeks prior to treatment, with the exception of vaccination against COVID-19
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase II, Open-Label Trial of Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
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.
Read more
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.
- Conditions
- Thymic Epithelial Tumor, Recurrent Thymoma, Thymic Cancer
- Being tested
- M7824
- Keywords
- Thymoma, thymic cancer, Immune Checkpoint Inhibition, programmed death ligand 1 (PD-L1)
- Medical subject headings
- Thymic epithelial tumor, Thymoma, Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M7824Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Bintrafusp alfa (M7824) | Experimental | 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. Receives: Drug: M7824 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
overall response rate for M7824 based on RECIST criteria
Measured: from the start of the treatment until disease progression/recurrence
Secondary outcomes (2)
Duration of response, progression free survival & overall survival
To determine duration of response, progression free survival and overall survival in participants with recurrent thymic epithelial TETs
Measured: from the start of the treatment until disease progression/recurrence
Safety & 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
Measured: from the start of the treatment until disease progression/recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start26 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thymic Epithelial TumorStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Arun Rajan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417660
- Sponsor's protocol ID
- 200097
- Other IDs
- 20-C-0097
- Status last verified
- 13 Oct 2026
- First submitted
- 4 Jun 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label Trial of Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
- ClinicalTrials.gov ID
- NCT04417660
- Acronym / sponsor ID
- 200097
- Conditions
- Thymic Epithelial Tumor, Recurrent Thymoma, Thymic Cancer
- Keywords
- Thymoma, thymic cancer, Immune Checkpoint Inhibition, programmed death ligand 1 (PD-L1)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bintrafusp alfa (M7824) | Experimental | Drug: M7824Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until disease progression or development of intolerable adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- 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 PD-1 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 biopsy); prior systemic therapy (or 5 half-lives of a drug, whichever is shorter) with immunosuppressive agents within 14 days before treatment; use of hormonal agents for anti-cancer therapy within 7 days before treatment; or use of any investigational drug within 14 days before treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M7824Bintrafusp 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 | Bintrafusp alfa (M7824) |
Primary outcome
Objective response rate
Time frame: from the start of the treatment until disease progression/recurrence
overall response rate for M7824 based on RECIST criteria
2 secondary outcomes
Duration of response, progression free survival & overall survival
Time frame: from the start of the treatment until disease progression/recurrence
Safety & tolerability of M7824
Time frame: from the start of the treatment until disease progression/recurrence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 34393061Remon 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Rajan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M7824 in people with Thymic Epithelial Tumor and Recurrent Thymoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: from the start of the treatment until disease progression/recurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04417660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.