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

NCT04417660 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 20009720-C-0097
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Thymoma; Thymic Cancer; Thymic Epithelial Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  overall response rate for M7824 based on RECIST criteria

  from the start of the treatment until disease progression/recurrence

Secondary Outcomes (2)

• Duration of response, progression free survival & overall survival

  from the start of the treatment until disease progression/recurrence

• Safety & tolerability of M7824

  from the start of the treatment until disease progression/recurrence

Study Arms (1)

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.

Drug: M7824

Interventions

M7824 DRUG

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.

Bintrafusp alfa (M7824)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically 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 measurable lesion by RECIST1.1.
• Participants must be aged \>=18 years.
• ECOG performance status \<=1.
• Participants must have adequate organ and marrow function as defined below:
• absolute neutrophil count: \>= 1,500/mm3 OR \>= 1.5 x 10(9)/L
• platelets: \>=\> 100,000/mm3 OR \>= 100 x 10(9)/L
• hemoglobin: \>= 9g/dL (may have been transfused)
• total bilirubin: \<= the upper limit of normal range (ULN) OR \<= 3.0 x ULN for participants with documented metastatic disease to the liver
• AST(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
• creatinine clearance: \>= 60 mL/min/1.73 m2 calculated by calculated using eGRF in the clinical lab
• INR: normal INR, per institutional guidelines
• PT: \<= 1.5 x ULN

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 34393061 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Thymic epithelial tumor; Thymoma; Thymus Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Arun Rajan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 5, 2020
• Study Start: December 26, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03-26

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)