- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05303844
Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites
April 11, 2023 updated by: Peng Wang, Fudan University
A Phase 1b Dose-escalation and Cohort-expansion Study of the Safety/Tolerability, and Efficacy of Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites (OPTIONS-02)
The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab for patients with refractory malignant ascites.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is to evaluate the safety, effectiveness of local immune activation, and efficiency in patients with refractory malignant ascites after Intraperitoneal injection of oncolytic Viruses H101 and Tislelizumab.
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China
- Recruiting
- Fudan University Shanghai Cancer Center
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Contact:
- Peng Wang, MD
- Phone Number: 86-21-64175590
- Email: wangp413@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Written informed consent obtained.
- Age ≥ 18 years at time of study entry.
- Pathologically diagnosed solid tumor malignancy.
- Malignant peritoneal ascites confirmed by peritoneal brush cytology.
- Failures from chemotherapy against malignant ascites.
- Cooperative Oncology Group-Status (ECOG Status) 0 or 1
Exclusion Criteria:
- Previous (<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.
- History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
- Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
- Prior treatment with oncolytic virotherapy.
- Radiotherapy administered less then 4 weeks prior to study treatment start.
- Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
- Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
- Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.
- Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:
- history of interstitial lung disease
- Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
- known acute or chronic pancreatitis
- active tuberculosis
- any other active infection (viral, fungal or bacterial) requiring systemic therapy
- history of allogeneic tissue/solid organ transplant
- diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tislelizumab treatment.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.
- Live vaccine within 30 days prior to the first dose of Tislelizumab treatment or during study treatment.
- History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of Tislelizumab treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS
- Medication that is known to interfere with any of the agents applied in the trial.
- Any other efficacious cancer treatment except protocol specified treatment at study start.
- Patient has received any other investigational product within 28 days of study entry.
- Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: H101 + Tislelizumab
(Dose escalation and cohort expansion) H101 administered by Intraperitoneal injection in combination with Tislelizumab administered intravenously (IV).
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H101 intratumorally injection starts at day 0.
Tislelizumab will be initiated on day 1.
Tislelizumab will be administered at 200 mg i.v.
every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 5.0
Time Frame: 28 days
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The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up).
A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
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28 days
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Maximum tolerated dose (MTD) of intratumoral injection of H101 on at three dose levels in combination with anti-PD1 antibody.
Time Frame: 28 days
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A MTD is determined if any cohort experiences 2 subjects with DLT's.
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28 days
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: max 24 months
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max 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: max 24 months
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ORR according to RECIST 1.1
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max 24 months
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Ascites Objective Response Rate
Time Frame: max 24 months
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The ascites objective response rate (ORR) was calculated as a summed ratio of patients with disappeared and decreased ascites to the total number of patients.
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max 24 months
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Duration of Response
Time Frame: max 24 months
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max 24 months
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Progression Free Survival
Time Frame: max 24 months
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max 24 months
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Overall survival
Time Frame: max 42 months
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max 42 months
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disease control rate
Time Frame: max 24 months
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max 24 months
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Change from baseline local immune effects after H101 intraperitoneal injections
Time Frame: max 24 months
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Detection of increased local immune activation in malignant ascites will be assessed by single cell sequencing and/or Mass Cytometry (CyTOF).
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max 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2022
Primary Completion (Anticipated)
March 20, 2025
Study Completion (Anticipated)
March 20, 2025
Study Registration Dates
First Submitted
March 21, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2201249-7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractory Malignant Ascites
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