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ACTIVE NOT RECRUITING Phase 1

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

NCT02955290 · View on ClinicalTrials.gov ↗

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.

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

228 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02955290

The ClinicalTrials.gov registry entry for NCT02955290 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 228 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02955290 reports 5 study locations spanning 3 distinct geographic areas — top geographies include New York, Indiana, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02955290?

This trial is sponsored by Roswell Park Cancer Institute, which has 228 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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