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NCT02955290 · ClinicalTrials.gov registry record · Phase 1

CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer

A Phase 1 study of Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, sponsored by Roswell Park Cancer Institute.

Active
Registry status
Phase 1
Development phase
51
Enrollment target
5
Study locations

NCT02955290 is a Phase 1 study of Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8 that is active but no longer recruiting, run by Roswell Park Cancer Institute. The registered enrollment target is 51 participants, below the 159-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (68% lower). The trial reports 5 study locations across 3 states.

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The verdict

NCT02955290, a Phase 1 study of Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by Roswell Park Cancer Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
51 participants
Enrollment target
5
Study locations

Study Summary

This phase I/II trial studies the best dose and side effects of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax) and nivolumab and to see how well they work in treating patients with non-small cell lung cancer or squamous head and neck cancer that has spread to other places in the body. Vaccine therapy, such as CIMAvax vaccine may help slow down and stop tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CIMAvax vaccine together with nivolumab or pembrolizumab may work better in treating patients with non-small cell lung cancer or squamous head and neck cancer.

Conditions Studied

Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Metastatic Lung Non-Small Cell Carcinoma Stage IIIB Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Recurrent Head and Neck Squamous Cell Carcinoma Stage IIIC Lung Cancer AJCC v8 Advanced Head and Neck Squamous Cell Carcinoma Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 PD-L1 Positive

Interventions

  • BIOLOGICAL Pembrolizumab
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine

Study Locations (5)

New York

  • Roswell Park Cancer Institute - Buffalo
  • St. Francis Hospital - Roslyn
  • Good Samaritan Hospital - West Islip

Indiana

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2016-12-22
Est. Completion 2027-12-09
Phase Phase 1

Sponsor

Roswell Park Cancer Institute

365 total trials

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What the Registry Record Tells You About NCT02955290

The ClinicalTrials.gov registry entry for NCT02955290 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 159-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (68% lower). The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT02955290 reports 5 study locations spanning 3 distinct geographic areas - top geographies include New York, Indiana, Ohio.

Frequently Asked Questions

What is clinical trial NCT02955290 about?

NCT02955290 is a clinical study titled "CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer". This phase I/II trial studies the best dose and side effects of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax) and nivolumab and to see how well they work in treating patients with non-small cell lung cancer or squamous head and neck cancer that has spread to other places in the body...

What is the current status of trial NCT02955290?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2016-12-22. Estimated completion is 2027-12-09.

What conditions does trial NCT02955290 study?

This clinical trial studies the following conditions: Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8.

What interventions are being tested in trial NCT02955290?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02955290?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02955290 being conducted?

This trial has 5 study locations across Indiana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.