Study on CIMAvax Vaccine, Nivolumab, and Pembrolizumab for Treating Advanced Lung and Head and Neck Cancers

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02955290

Provider View

This clinical trial is exploring a combination of the CIMAvax vaccine with immunotherapy drugs nivolumab and pembrolizumab to treat advanced non-small cell lung cancer and squamous head and neck cancer. The study aims to find the best dose, understand side effects, and see how well these treatments work together.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) and squamous head and neck cancer. It combines the CIMAvax vaccine with immunotherapy drugs nivolumab and pembrolizumab. The goal is to find the best dose, understand any side effects, and see if this combination can help slow down or stop the growth of tumors. The study is divided into two phases: Phase I focuses on finding the safest dose, while Phase II looks at how well the treatment works over time.

Description

The study is divided into several parts:

  • Phase I: This phase aims to find the safest dose of CIMAvax when combined with nivolumab by monitoring side effects. Patients will receive CIMAvax and nivolumab every two weeks for four doses. If no severe side effects occur, they will continue with CIMAvax every four weeks and nivolumab every two weeks.

  • Phase II: This phase is split into different studies:

    • Study A: Evaluates the survival of patients with advanced NSCLC treated with CIMAvax and nivolumab.
    • Study B: Looks at the progression-free survival of patients with recurrent squamous cell carcinoma of the head and neck treated with CIMAvax and nivolumab.
    • Study C: Tests CIMAvax and pembrolizumab in patients with NSCLC who have high PD-L1 expression.
    • Study D: Focuses on patients with squamous NSCLC with low PD-L1 expression after initial chemotherapy.
    • Study E: Involves patients with non-squamous NSCLC without certain mutations and low PD-L1 expression after initial chemotherapy.

After completing the study treatment, patients will be followed up every 30 days for 120 days to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0 to 2, meaning they are fully active or have some restrictions but can still do light work.
  • Diagnosed with advanced non-small cell lung cancer (NSCLC) or squamous head and neck cancer.
  • Eligible for nivolumab treatment as part of standard care.
  • For specific studies, patients must have certain PD-L1 expression levels or have undergone previous treatments.
  • Must have a life expectancy of at least 6 months.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must use effective birth control during the study.
  • Must provide informed consent and agree to study procedures, including providing tumor and blood samples.

Exclusion Criteria

  • Have received chemotherapy or other investigational treatments recently.
  • Have had previous anti-PD1 or PD-L1 immunotherapy, except in certain study groups.
  • Have untreated or active brain metastases.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Are currently using systemic steroids or have not recovered from their side effects.
  • Have serious infections or uncontrolled medical conditions.
  • Are pregnant or breastfeeding.
  • Have a history of severe heart conditions or other serious health issues.
  • Have had another invasive cancer within the past two years, with some exceptions.

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