Thymoma and Thymic CarcinomaPhase 4NCT04554524
Chemotherapy Combined With Pembrolizumab in Treating Patients With Thymoma and Thymic Carcinoma
A Phase 4 study testing Chemotherapy+Pembrolizumab. in people with Thymoma and Thymic Carcinoma, run by Tang-Du Hospital at 1 site in China.
Trial summary
This is an investigational, single arm study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymoma and Thymic Carcinoma
- What is being tested?
- Chemotherapy+Pembrolizumab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2020to 30 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Have a histologically or cytologically confirmed diagnosis of unresectable thymoma or thymic carcinoma.
- Have measurable disease based on RECIST 1.1.
- Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymoma or thymic carcinoma.
- Patients who could provision of archival to evaluate the PD-L1 expression status.
- Be ≥ 18 years of age on day of signing informed consent.
- Life expectancy > 3 months.
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- Have a performance status (PS) of 0 or 1 on the ECOG PS.
- Demonstrate adequate organ function as defined below all screening labs should be performed.
- Hematological: absolute neutrophil count ≥ 1500/mcL; platelets ≥ 80000mcL; hemoglobin ≥ 9g/dL or ≥ 5.6 mmol/L without transfusion within 4 weeks.
- Renal: serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5 X upper limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN.
- Hepatic: serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; albumin ≥ 2.5mg/dL.
- Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Female subject of childbearing potential should have a negative urine or serum pregnancy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Who cannot join
- Patients have had prior systemic anti-cancer therapy.
- Has a known additional malignancy past 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 3 days prior to trial treatment.
- Hypersensitivity to carboplatin or paclitaxel or nab-paclitaxel or any of their excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Asthmatic subjects requiring intermittent use of bronchodilators, inhaled steroids or local steroid injections were not excluded.
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- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Participated in any other pembrolizumab trials or was treated with pembrolizumab.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- As known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
Trial locations and contacts
1 site in 1 country.
Xunliang Yin contact
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi
Yongan Zhou
About this study
Official title: Single-Arm Study to Carbo-paclitaxel/ Nab-paclitaxel Combined With Pembrolizumab as the First Line Therapy in Treating Patients With Locally Advanced or Metastatic Invasive Thymoma and Thymic Carcinoma That Cannot Be Removed by Surgery
This is an investigational, single arm study.
Read the detailed description
Pembrolizumab is FDA approved and commercially available for treatment of many types of cancers. It is considered investigational to use chemotherapy combined with pembrolizumab to treat thymoma or Thymic carcinoma.
Subjects will be evaluated for eligibility during a 28-day screening period. Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Up to 40 participants will be enrolled in this study.
- Conditions
- Thymoma and Thymic Carcinoma
- Being tested
- Chemotherapy+Pembrolizumab.
- Keywords
- Thymoma, Thymic carcinoma, Pembrolizumab
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy+Pembrolizumab.Drug
Also called Carbo-paclitaxel/ nab-paclitaxel
Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). After 4 cycles treatment, complete response subjects continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, some of partial disease and stable disease subjects can receive surgical treatment. And then continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, other partial disease and stable disease subjects cannot be removed by surgery will continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab for 4 cycles and then pembrolizumab or Normal Saline up to disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy+Pembrolizumab | Experimental | Chemotherapy combined with pembrolizumab. Receives: Drug: Chemotherapy+Pembrolizumab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate.
Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Measured: After 4 cycles (each cycle is 21 days) treatment up to 4 years.
Secondary outcomes (1)
Progression-free Survival.
Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Measured: After 4 cycles (each cycle is 21 days) treatment up to 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start27 Aug 2020
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymoma and Thymic CarcinomaStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongan Zhou, MD, Tang-Du Hospital
- Investigators
- Yongan Zhou, Study chair, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554524
- Sponsor's protocol ID
- K202008-07
- Status last verified
- Oct 2020
- First submitted
- 7 Sep 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm Study to Carbo-paclitaxel/ Nab-paclitaxel Combined With Pembrolizumab as the First Line Therapy in Treating Patients With Locally Advanced or Metastatic Invasive Thymoma and Thymic Carcinoma That Cannot Be Removed by Surgery
- ClinicalTrials.gov ID
- NCT04554524
- Acronym / sponsor ID
- K202008-07
- Conditions
- Thymoma and Thymic Carcinoma
- Keywords
- Thymoma, Thymic carcinoma, Pembrolizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 18 Sep 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.
This is an investigational, single arm study.
Detailed description
Pembrolizumab is FDA approved and commercially available for treatment of many types of cancers. It is considered investigational to use chemotherapy combined with pembrolizumab to treat thymoma or Thymic carcinoma.
Subjects will be evaluated for eligibility during a 28-day screening period. Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Up to 40 participants will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy+Pembrolizumab | Experimental | Drug: Chemotherapy+Pembrolizumab.Chemotherapy combined with pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have a histologically or cytologically confirmed diagnosis of unresectable thymoma or thymic carcinoma.
- Have measurable disease based on RECIST 1.1.
- Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymoma or thymic carcinoma.
- Patients who could provision of archival to evaluate the PD-L1 expression status.
- Be ≥ 18 years of age on day of signing informed consent.
Key exclusion criteria (12 listed)
- Patients have had prior systemic anti-cancer therapy.
- Has a known additional malignancy past 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 3 days prior to trial treatment.
- Hypersensitivity to carboplatin or paclitaxel or nab-paclitaxel or any of their excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic 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 |
|---|---|---|
| Chemotherapy+Pembrolizumab.Also: Carbo-paclitaxel/ nab-paclitaxelEligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). After 4 cycles treatment, complete response subjects continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, some of partial disease and stable disease subjects can receive surgical treatment. And then continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, other partial disease and stable disease subjects cannot be removed by surgery will continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab for 4 cycles and then pembrolizumab or Normal Saline up to disease progression. | Drug | Chemotherapy+Pembrolizumab |
Primary outcome
Objective Response Rate.
Time frame: After 4 cycles (each cycle is 21 days) treatment up to 4 years.
Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
1 secondary outcome
Progression-free Survival.
Time frame: After 4 cycles (each cycle is 21 days) treatment up to 4 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
Xunliang Yin contact
Yongan Zhou study chair
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chemotherapy+Pembrolizumab. in people with Thymoma and Thymic Carcinoma, run by Tang-Du Hospital at 1 site in China.
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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 28 Oct 2020. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongan Zhou (86-13700287519, Zhou.yongan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate. (time frame: After 4 cycles (each cycle is 21 days) treatment up to 4 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2020.