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

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ClinicalTrials.gov Identifier: NCT04525859
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : April 4, 2022
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Oncovir, Inc.

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

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Biological: Safety Biological: Expansion Cohort Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study Subjects will receive poly-ICLC once within the pleural mesothelioma. Up to twenty one days later he/she will undergo surgery per the standard of care by the thoracic surgeon. The type of surgery will be decided upon by the treating thoracic surgeon. Follows up visits are scheduled every three months for the first year and then every 6 months thereafter. CT scans or surveillance scans to look for recurrences will be ordered by the treating surgeon and/or medical oncologist per the standard of care. If there is a need for adjuvant (after surgery) therapy, such as chemotherapy or radiation, this will be discussed with the study subject per the standard of care by the surgeon and/or a medical oncologist or radiation oncologist.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Safety
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.
Biological: Safety
See previous Safety group description

Experimental: Expansion Cohort
If at most one (1) patient in the Phase 1 safety cohort experiences a DLT then a total of thirteen (13) additional patients will be enrolled into the Phase 1b Expansion Cohort. Patients in the Expansion Cohort will receive the same dose and schedule of Poly-ICLC as in the Phase 1 safety cohort. Patients will be followed for safety and tolerability, as well as efficacy. If a total of 4 or more patients experience DLTs then the study will be closed due to excessive toxicity.
Biological: Expansion Cohort
See previous Expansion Cohort

Primary Outcome Measures :
  1. 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%. [ Time Frame: up to 27 days ]
    Safety will be assessed by the frequency and severity of toxicities by use of NCI-CTCAE 5.0 criteria.

Secondary Outcome Measures :
  1. Objective response rate by RECIST 1.1 using CT imaging. [ Time Frame: up to 27days ]
    Local Recurrence-free survival from time of first injection until first date that locally recurrent disease is confirmed or date of documented death.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525859

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Contact: Director, New York Mesothelioma Program 212-241-9502 andrea.wolf@mountsinai.org
Contact: David Yankelevitz, MD 212-241-8333 dfyank@gmail.com

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United States, New York
Icahn School of Medicine Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Andrea Wolf    212-241-9502    andrea.wolf@mountsinai.org   
Sponsors and Collaborators
Oncovir, Inc.
Icahn School of Medicine at Mount Sinai
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Study Director: Thomas Marron, MD Assistant Director
Publications of Results:

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Responsible Party: Oncovir, Inc.
ClinicalTrials.gov Identifier: NCT04525859    
Obsolete Identifiers: NCT04345705
Other Study ID Numbers: GCO#19-2701
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Rebecca Hernandez is the Administrative Assistant for this study and should have access to the PRS for this study.

Contact Information:

email: rebecca.hernandez@mssm.edu Phone: 212-824-9472.

Supporting Materials: Study Protocol
Time Frame: Duration of the Study
Access Criteria: Read/Write access to the protocol Should receive all clinicaltrial.gov notices relating to this study

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oncovir, Inc.:
Malignant Pleural Mesothelioma (MPMV
Additional relevant MeSH terms:
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Mesothelioma, Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases