Malignant Pleural Mesothelioma Clinical Trial
Official title:
A Phase 1B Study to Evaluate the Safety and Induction of Immune Response of CRS-207 in Combination With Pemetrexed and Cisplatin as Front-line Therapy in Adults With Malignant Pleural Mesothelioma
Verified date | September 2020 |
Source | Aduro Biotech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such as mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 19, 2019 |
Est. primary completion date | September 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have histologically confirmed epithelial or biphasic MPM not amenable to potentially curative surgical resection (subjects with biphasic tumors that have a predominantly (=50%) sarcomatoid component will be excluded) - Be at least 18 years of age - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Have an anticipated life expectancy of greater than 6 months - For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.) - Be willing and able to give written informed consent, and be able to comply with all study procedures - Have adequate organ function as defined by specified laboratory values Exclusion Criteria: - A candidate for curative surgery - Surgery within 2 weeks prior to dosing - Prior radiotherapy or biologic therapy - Treatment with an investigational agent within 4 weeks before dosing - Prior systemic chemotherapy - Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions - Documented and ongoing brain metastases - Have any evidence of hepatic cirrhosis or clinical or radiographic ascites - Have clinically significant and/or malignant pleural effusion - Known or suspected allergy or hypersensitivity to yeast or any other component of CRS-207 (e.g., glycerol), Platinol or platinum-containing compounds, or pemetrexed - Used any systemic steroids within 28 days of study treatment - Use more than 3 g/d of acetaminophen - An artificial (prosthetic) joint or other artificial implant or device that cannot be easily removed (with some exceptions for dental and breast implants and biliary stents and mediports) - Infection with HIV or hepatitis B or C at screening - Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment - Be a woman who is pregnant or breastfeeding - Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen - Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures |
Country | Name | City | State |
---|---|---|---|
United States | National Cancer Institute | Bethesda | Maryland |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania |
United States | University of California at San Francisco | San Francisco | California |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Aduro Biotech, Inc. |
United States,
Le DT, Dubenksy TW Jr, Brockstedt DG. Clinical development of Listeria monocytogenes-based immunotherapies. Semin Oncol. 2012 Jun;39(3):311-22. doi: 10.1053/j.seminoncol.2012.02.008. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting Adverse Events | Count of subjects with incidences of adverse events. | From first study dose until 28 days after the final dose (an average of 44 weeks) | |
Primary | Induction of Immune Response to Mesothelin by Enzyme-linked Immunosorbent Spot (ELISPOT) Assay | Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer) | ||
Secondary | Objective Tumor Response | Objective tumor response was measured using modified Response Evaluation Criteria in Solid Tumors (mRECIST) for assessment of response in malignant pleural mesothelioma (MPM). Per mRECIST for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, those who fulfilled the criteria for neither PR nor PD; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions. | Baseline to measured disease progression or death (up to 12 months or longer) | |
Secondary | Time to Progression | From date of randomization until date of documented progression (by modified RECIST or immune-related response criteria) or death, assessed up to 12 months or longer | ||
Secondary | Serum Mesothelin as Correlate of Therapeutic Response | Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer) |
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