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

NCT04525859 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GCO#19-2701
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Pleural Mesothelioma

Keywords

Malignant Pleural Mesothelioma (MPMV; Vaccine; Poly-ICLC

Outcome Measures

Primary Outcomes (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%.

  Safety will be assessed by the frequency and severity of toxicities by use of NCI-CTCAE 5.0 criteria.

  up to 27 days

Secondary Outcomes (1)

• Objective response rate by RECIST 1.1 using CT imaging.

  up to 27days

Study Arms (2)

Safety

EXPERIMENTAL

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

Expansion Cohort

EXPERIMENTAL

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

Interventions

Safety BIOLOGICAL

See previous Safety group description

Safety

Expansion Cohort BIOLOGICAL

See previous Expansion Cohort

Expansion Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven MPM
• a. If biopsied at an outside institution, must have a tissue block sample available
• Deemed to be surgically resectable by a dedicated thoracic surgeon.
• 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.
• Patient must be able to provide informed consent
• Subject is willing to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

• Serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive Poly-ICLC with reasonable safety.
• History of any pulmonary process that precludes a biopsy to be done safely.
• 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.
• Subject unable to cooperate in terms of maintaining position during the biopsy procedure.
• 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.
• Persistent toxicity from recent therapy that has not sufficiently resolved in the judgment of the study physician.
• Subject has an active infection requiring therapy.
• Subject has had an allogeneic tissue/solid organ transplant.
• 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.
• 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.
• Concomitant comorbidities that are uncontrolled that would preclude the patient from being a surgical candidate including uncontrolled CHF, diabetes or heart disease
• Women with a positive serum or urine pregnancy test at baseline, or are pregnant or breastfeeding.

Sponsors & Collaborators

• Oncovir, Inc.: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Icahn School of Medicine Mount Sinai

New York, New York, 10029, United States

Location

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MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Safety

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Thomas Marron, MD

  Assistant Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 25, 2020
• Study Start: August 19, 2020
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)