Sacituzumab Govitecan for Thymic Cancer
Palo Alto (17 mi)Overseen byChul Kim, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Georgetown University
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy.
The main question it aims to answer is:
• What is the overall response rate (ORR) in patients with advanced thymoma and thymic carcinoma?
Participants will:
* receive a fixed dose of 10 mg/kg given intravenously, once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity
* have regular blood tests, scans, and examinations to monitor their health.
* have blood and a biopsy of their tumor for research purposes.
What safety data is available for Sacituzumab Govitecan in treating thymic cancer?The provided research does not contain safety data for Sacituzumab Govitecan or its other names (Trodelvy, sacituzumab govitecan-hziy, IMMU-132, hRS7-SN38) in the context of thymic cancer. The studies focus on other treatments like sunitinib, pembrolizumab, atezolizumab, and avelumab with axitinib for thymic cancer.237911
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, it does state that no concurrent therapy with approved or investigational anticancer therapeutics is allowed. It's best to discuss your specific medications with the trial team.
Is the drug Sacituzumab Govitecan a promising treatment for thymic cancer?The information provided does not mention Sacituzumab Govitecan, so we can't determine if it's a promising treatment for thymic cancer based on this data.1231011
What data supports the idea that Sacituzumab Govitecan for Thymic Cancer is an effective drug?The available research does not provide any data on Sacituzumab Govitecan for Thymic Cancer. Instead, the studies focus on other treatments and conditions, such as isatuximab for multiple myeloma. Therefore, there is no information here to support the effectiveness of Sacituzumab Govitecan for Thymic Cancer.456812
Eligibility Criteria
This trial is for adults with advanced thymoma or thymic carcinoma who have already tried at least one treatment without success. Participants will receive ongoing cycles of a drug called Sacituzumab Govitecan, given through the vein once weekly on specific days, and will be monitored regularly.Inclusion Criteria
I agree to either not have sex or use birth control, and not to donate sperm.
My hepatitis B is under control or I'm on treatment, and if I had hepatitis C, it's been treated.
I am 18 years old or older.
I can take care of myself and am up and about more than half of my waking hours.
I have been diagnosed with advanced thymoma or thymic carcinoma.
My blood and organ tests meet the required health standards.
My condition worsened after at least one treatment.
Exclusion Criteria
I am not currently receiving any cancer treatment.
Treatment Details
The trial tests Sacituzumab Govitecan's effectiveness in treating advanced thymoma and thymic carcinoma. The key measure is the overall response rate to this medication after previous treatments failed. Patients get fixed doses over continuous 21-day cycles until they can't tolerate it or their disease gets worse.
1Treatment groups
Experimental Treatment
Group I: SacituzumabExperimental Treatment1 Intervention
Sacituzumab Govitecan is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Trodelvy for:
- Metastatic triple-negative breast cancer
- Locally advanced or metastatic urothelial cancer (withdrawn)
- Metastatic HR+/HER2- breast cancer
🇪🇺 Approved in European Union as Trodelvy for:
- Metastatic triple-negative breast cancer
🇨🇦 Approved in Canada as Trodelvy for:
- Metastatic triple-negative breast cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Stanford Cancer InstitutePalo Alto, CA
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington, United States
Loading ...
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
Gilead SciencesIndustry Sponsor
References
Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs). [2022]No previous prospective trials have been reported with capecitabine and gemcitabine (CAP-GEM) in patients with metastatic thymic epithelial tumors (TETs). We conducted a multicenter study to determine the activity and tolerability of this regimen in pretreated TETs.
Sunitinib effective for rare thymus cancer. [2018]In a phase II trial, the tyrosine kinase inhibitor sunitinib was effective in previously treated patients with thymic carcinoma, offering the first viable second-line treatment option for patients with this rare and aggressive form of thymus cancer.
Pembrolizumab for Patients With Refractory or Relapsed Thymic Epithelial Tumor: An Open-Label Phase II Trial. [2020]Limited treatment options exist for patients with thymic epithelial tumor (TET) whose disease progresses after platinum-based chemotherapy. We conducted a phase II study of pembrolizumab in patients with TET to evaluate its efficacy and safety.
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. [2020]Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma.
Outcomes of anti-CD38 isatuximab plus pomalidomide and dexamethasone in five relapsed myeloma patients with prior exposure to anti-C38 daratumumab: case series. [2022]Objectives: Daratumumab is the first anti-CD38 monoclonal antibody (Mab) used to treat myeloma in the newly diagnosed setting and in the relapsed setting. Isatuximab, another Mab targeting a specific epitope on the CD38 receptor, was recently approved in the UK in combination with pomalidomide and dexamethasone (IsaPomDex) to treat myeloma patients who received three prior lines of therapy. However, there is a lack of understanding of whether using a prior anti-CD38 Mab (e.g. daratumumab) can affect the efficacy of another Mab (e.g. isatuximab), when the latter is used to treat a subsequent relapse.Methods: We performed a UK-wide outcomes study of IsaPomDex in the real-world. In this case series, we report a detailed descriptive analysis of the characteristics and clinical outcomes of five IsaPomDex patients in UK routine practice (Patients I to V), with a prior exposure to daratumumab.Results: Age range was 51-77 years with two patients >70 and three patients <70 years. The cytogenetic risk was standard in two patients, high in two patients and not known in one patient. Prior daratumumab regimen were monotherapy (dara-mono) in one patient (II), and daratumumab with bortezomib and dexamethasone (DVd) in four patients. Responses to prior daratumumab were: very good partial response (VGPR) in two patients (I and III), minor response-stable disease (MR-SD) in one patient (II), and progressive disease (PD) in two patients (IV and V). Median (range) number of IsaPomDex cycles received was 2 (1-4). Outcomes of IsaPomDex were PD in three patients (II, IV and V) and a response in two patients. Response categories were: MR-SD in patient I and PR in patient III.Discussion: Despite the limitations of our case series, we described the first UK real-world report of IsaPomDex outcomes in myeloma patients with a prior exposure to daratumumab.Conclusion: Large prospective studies are required to further evaluate myeloma outcomes in this setting.
Daratumumab Improves Depth of Response and Progression-free Survival in Transplant-ineligible, High-risk, Newly Diagnosed Multiple Myeloma. [2022]Patients with high-risk, newly diagnosed multiple myeloma (HR-NDMM) who are ineligible for autologous stem cell transplant (ASCT) have limited first-line treatment options. Recent meta-analyses evaluating the impact of incorporating daratumumab in the backbone regimen on progression-free survival (PFS) have found mixed results in these patients.
Autoimmune Disease in Patients With Advanced Thymic Epithelial Tumors. [2023]Paraneoplastic autoimmune diseases (ADs) are a hallmark of thymic epithelial tumors (TETs) and affect treatment management in patients with advanced-stage tumors, yet the risk factors for development of AD in advanced TET remain poorly understood.
Isatuximab plus atezolizumab in patients with advanced solid tumors: results from a phase I/II, open-label, multicenter study. [2022]The anti-CD38 antibody isatuximab is approved for the treatment of relapsed/refractory multiple myeloma, but there are no data on its efficacy in solid tumors. This phase I/II study (NCT03637764) assessed the safety and activity of isatuximab plus atezolizumab (Isa + Atezo), an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with immunotherapy-naive solid tumors: epithelial ovarian cancer (EOC), glioblastoma (GBM), hepatocellular carcinoma (HCC), and squamous cell carcinoma of the head and neck (SCCHN).
Avelumab plus axitinib in unresectable or metastatic type B3 thymomas and thymic carcinomas (CAVEATT): a single-arm, multicentre, phase 2 trial. [2022]Patients with advanced type B3 thymoma and thymic carcinoma resistant to chemotherapy have few treatment options. We report the efficacy and safety results of the combination of the anti-PD-L1 inhibitor avelumab with the anti-angiogenesis drug axitinib in patients with advanced type B3 thymoma and thymic carcinoma.
Emerging therapies in thymic epithelial tumors (Review). [2023]Thymic epithelial tumors (TETs), including thymomas and thymic carcinomas, are rare malignancies arising from the thymus gland. The optimal management requires a multidisciplinary approach. Standard first-line systemic treatment involves cytotoxic chemotherapeutic regimens; however, alternative options for systemic treatment are required. Current research focuses on the unique profile of immune-related pathogenic mechanisms of TETs, involving an overlap with certain autoimmune phenotypes, as well as on determining the landscape of oncogenic molecular alterations and the role of tumor angiogenesis. The aim of the present review is to summarize the current clinical investigation on immunotherapy and targeted agents in the management of TETs. Regarding immune checkpoint inhibitors, efficacy results are promising in certain subsets of patients; however, caution is required concerning their toxicity. Anti-angiogenic agents, mainly potent small-molecule inhibitors, have demonstrated antitumor activity in TETs, whereas other targeted agents, including KIT inhibitors and epigenetic agents, are associated with encouraging, yet still modest results for unselected populations, in the absence of predictive biomarkers. Future research should focus on identifying predictive biomarkers for patients with TETs, and should implement multicenter collaborations and appropriate clinical trials tailored for rare tumor types.
Study Design and Rationale for Marble Study: A Phase II Trial of Atezolizumab (MPDL3280A) Plus Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Thymic Carcinoma (JTD2101). [2023]Thymic carcinoma (TC) is a rare thymic epithelial tumor, and advanced or recurrent TC has limited prognosis. Treatment for chemotherapy-naïve, advanced, or recurrent TC remains unchanged with the combination of carboplatin and paclitaxel; therefore, a new treatment strategy is warranted. Immune checkpoint blockades inhibiting the programmed cell death-1 (PD-1) pathway (PD-1 and its ligand, PD-L1) have shown potential as a monotherapy for TC, although the efficacy of monotherapy was moderate for previously treated TC. We hypothesized that the combination of an anti-PD-L1 antibody, atezolizumab, with carboplatin and paclitaxel, would be effective in inducing immunogenic cell death in patients with advanced or recurrent TC.
Varicella zoster virus reactivation reported with isatuximab use. [2023]Isatuximab is a CD38-directed antibody indicated for the treatment of relapsed or refractory multiple myeloma. The Division of Pharmacovigilance at the U.S. Food and Drug Administration (FDA) reviewed case reports from postmarketing sources, including the FDA Adverse Event Reporting System (FAERS), PubMed, and Embase, to investigate a potential association between isatuximab and the risk of varicella zoster virus (VZV) reactivation. We identified 20 reports of which 15 met our case definition and causality criteria. All 15 patients (80% male, median age = 60 years) received isatuximab for a hematologic neoplasm; eight (53%) for previously untreated multiple myeloma. All cases described additional risk factors for VZV reactivation, including concomitant proteasome inhibitor and/or immunomodulatory drug (n = 10, 67%) use. Based on this postmarket analysis, the U.S. Prescribing Information for isatuximab was updated to include this new safety information, including recommendations for antiviral prophylaxis.