Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

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Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma. Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed Dendritic Cell-based Immunotherapy in Mesothelioma MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Do Your Genes Put You at a Higher Risk of Developing Mesothelioma Trimodality Therapy for Malignant Pleural Mesothelioma Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma Ganetespib With Platinum, in Patients With Malignant Pleural Mesothelioma Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma Dasatinib in Resectable Malignant Pleural Mesothelioma Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. 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Brief Title

Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Official Title

Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Brief Summary

      This study will examine the safety and potential effectiveness of poly-ICLC directly injected
      into malignant pleural mesothelioma at the time of biopsy up to 21 days prior to the cancer
      being removed by the surgeon
    

Detailed Description

      -  To evaluate the safety and toxicity of IT Poly-ICLC, Hiltonol® prior to surgical
           resection for patients with MPM.

        -  To determine objective response rate by RECIST 1.1 using CT imaging.

        -  To determine recurrence free survival of subjects treated with IT Poly-ICLC followed by
           surgical resection defined as the time of injection until the first date that recurrent
           disease is confirmed or date of documented death.

        -  To evaluate IT Poly-ICLC induced immune changes in the tumor microenvironment by
           comparing pre-injection biopsy to surgically resected tissue for immune cell
           infiltration and T cell receptor (TCR) diversity.

        -  To characterize additional immune parameters in IT Poly-ICLC injected tumors including
           in-depth phenotypic and functional characterization of immune infiltrating cells.

        -  To evaluate IT Poly-ICLC induced serological changes and changes of circulating immune
           cells, including regulatory T cells and NK cells, by comparing pre-injection to
           post-surgical resection blood samples.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the probability of accepting the treatment is at least 71% if the DLT rate is less than a safe level of 17%.

Secondary Outcome

 Objective response rate by RECIST 1.1 using CT imaging.

Condition

Malignant Pleural Mesothelioma

Intervention

Safety

Study Arms / Comparison Groups

 Safety
Description:  Six patients will be enrolled in the Phase 1 safety cohort. Patients will have an IR guided biopsy and FNA. Up to four core biopsies and FNAs at one site will be performed prior to intratumoral (IT) administration of Poly-ICLC. Pleural fluid will be collected for research analysis if available. Poly-ICLC will be injected in 2 locations within the pleura. Patients will undergo surgery 21±7 days after the biopsy and Poly-ICLC intratumoral (IT) injection. The type of surgery that will be performed is at the discretion of the thoracic surgeon and per the standard of care. This includes pleurectomy/decortication or extrapleural pneumonectomy. Patients will be evaluated per the standard of care post-operatively. On day 7±4 days a final toxicity assessment, physical exam and research blood will be collected. All post-operative care and monitoring thereafter is as per standard of care.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

19

Start Date

August 19, 2020

Completion Date

August 31, 2024

Primary Completion Date

August 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Biopsy proven MPM

             a. If biopsied at an outside institution, must have a tissue block sample available

          2. Deemed to be surgically resectable by a dedicated thoracic surgeon.

          3. Acceptable hematologic, renal and liver function as follows:

               -  Absolute neutrophil count > 1000/mm3

               -  Platelets > 50,000/mm3,

               -  Creatinine ≤ 2.5 mg/dl,

               -  Total bilirubin ≤ 1.5 mg/dl, unless patient has known Gilberts syndrome

               -  Transaminases ≤ 2 times above the upper limits of the institutional normal.

               -  INR<1.6 if off of anticoagulation. Patients on anticoagulation therapy with an
                  INR>1.6 may be enrolled at the discretion of the investigator if they have not
                  had any episodes of severe hemorrhage and if the site to be injected is fully
                  surrounded by pleura where achieving homeostasis would be complicated.

          4. Patient must be able to provide informed consent

          5. Subject is willing to adhere to the study visit schedule and other protocol
             requirements.

        Exclusion Criteria:

          1. Serious concurrent infection or medical illness, which would jeopardize the ability of
             the patient to receive Poly-ICLC with reasonable safety.

          2. History of any pulmonary process that precludes a biopsy to be done safely.

          3. Known severe pulmonary hypertension; having a history of pulmonary hypertension or an
             estimated PA systolic pressure of >60mmHg as measured by tricuspid regurgitation on
             preoperative echocardiogram.

          4. Subject unable to cooperate in terms of maintaining position during the biopsy
             procedure.

          5. AIDS defined as a CD4 count less than 200 in the context of HIV seropositivity or
             chronically is taking immunosuppressive medication such as steroids or transplant
             related medications.

          6. Persistent toxicity from recent therapy that has not sufficiently resolved in the
             judgment of the study physician.

          7. Subject has an active infection requiring therapy.

          8. Subject has had an allogeneic tissue/solid organ transplant.

          9. Subject has active autoimmune disease that has required systemic treatment within the
             past 2 years (eg, 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.

         10. Subject has known active Hepatitis B, Hepatitis C or tuberculosis. Active Hepatitis B
             is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known
             positive Hep C Ab result and known quantitative HCV ribonucleic acid (RNA) results
             greater than the lower limits of detection of the assay.

         11. Concomitant comorbidities that are uncontrolled that would preclude the patient from
             being a surgical candidate including uncontrolled CHF, diabetes or heart disease

         12. Women with a positive serum or urine pregnancy test at baseline, or are pregnant or
             breastfeeding.

             -
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas Marron, MD, 212-241-9502, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04525859

Organization ID

GCO#19-2701


Responsible Party

Sponsor

Study Sponsor

Oncovir, Inc.

Collaborators

 Icahn School of Medicine at Mount Sinai

Study Sponsor

Thomas Marron, MD, Study Director, Assistant Director


Verification Date

August 2020