Chemotherapy Combined With Pembrolizumab in Treating Patients With Thymoma and Thymic Carcinoma

NCT04554524 | Unknown Phase 4

• 1 other identifier: K202008-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigational, single arm study.

Conditions

Thymoma and Thymic Carcinoma

Keywords

Thymoma; Thymic carcinoma; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate.

  Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

  After 4 cycles (each cycle is 21 days) treatment up to 4 years.

Secondary Outcomes (1)

• Progression-free Survival.

  After 4 cycles (each cycle is 21 days) treatment up to 4 years.

Study Arms (1)

Chemotherapy+Pembrolizumab

EXPERIMENTAL

Chemotherapy combined with pembrolizumab.

Drug: Chemotherapy+Pembrolizumab.

Interventions

Chemotherapy+Pembrolizumab. DRUG

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.

Also known as: Carbo-paclitaxel/ nab-paclitaxel

Chemotherapy+Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Thymoma

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

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

Study Officials

• Yongan Zhou

  Tang-Du Hospital

  STUDY CHAIR

Central Study Contacts

Yongan Zhou

CONTACT

86-13700287519; Zhou.yongan@163.com

Xunliang Yin

CONTACT

86-13389283977

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Thoracic Surgery, Principal Investigator

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 18, 2020
• Study Start: August 27, 2020
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

CN (1)