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Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1

NCT03721679 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-02-01

No results posted yet for this study

Summary

This is an open labeled, non-randomized adaptive pilot study. The study interventions involved in this study are:

Poly-ICLC (Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose, also known as Hiltonol®) treatment in combination with anti-PD-1 (Nivolumab, Cemiplimab or Pembrolizumab) or anti-PD-L1 (Atezolizumab or Durvalumab)

Conditions

  • Solid Cancer

Interventions

BIOLOGICAL

Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months

Same as above

Sponsors & Collaborators

  • Chevy Chase Healthcare, Chevy Chase MD

    collaborator UNKNOWN

  • Mt. Sinai School of Medicine, New York, New York

    collaborator UNKNOWN

  • Bay Hematology Oncology PA, Easton MD

    collaborator UNKNOWN

  • Oncovir, Inc.

    lead INDUSTRY

Principal Investigators

  • Frederick P Smith, MD · Chevy Chase Healthcare

  • David H Smith, MD · Bay Hematology Oncology PA

  • Nina Bhardwaj, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2021-01-26
Completion
2021-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721679 on ClinicalTrials.gov