A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion
This is a Phase Ib/II clinical trial to evaluate the feasibility of administering talimogene laherparepvec into the intrapleural space of subjects with malignant pleural effusion through a pleurX catheter.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 20, 2021 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Interventions being studied
- Drug: Talimogene laherparepvec (TVEC); Drug: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Patients must meet the following inclusion criteria to participate in this study: 1. Be ≥ 18 years of age on day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 3. Histologically or cytologically confirmed stage IV metastatic cancer. 4. Confirmation of malignant pleural effusion via imaging (Computer tomography (CT) scan, chest x-ray (CXR), MRI, ultrasound, Positron Emission Tomography (PET)/CT), and cytology for which pleurX catheter placement is standard of care 5. Recovered from all reversible toxicities related to their previous treatment (other than alopecia) to ≤grade 1 or baseline; exceptions to this criterion may be allowed following review by the principal investigator for toxicities that are not expected to be exacerbated by nivolumab or talimogene laherparepvec. Grade 2 peripheral neuropathy will not result in exclusion as neither study agent would be expected to exacerbate it. 6. No history of untreated brain metastasis. Treated brain metastases must not be known to be progressive, symptomatic, or currently requiring \> 10 mg of prednisone or prednisone equivalents within two weeks prior to study drug administration. 7. Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Females of childbearing potential must agree to use 2 methods of effective contraception or abstain from heterosexual sex throughout the treatment period and for 5 months after the last dose of study treatment. Females of childbearing potential are women who have not been surgically sterilized (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not been free of menses for \>1 year. 8. Male patients with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e. double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 7 months after the last dose of study treatment.
Patients meeting any of the following
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 20, 2021. Always confirm current availability with the study team.