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Cancer Vaccine

CIMAvax Vaccine + Nivolumab + Pembrolizumab for Non-small Cell Lung Cancer and Squamous Head and Neck Cancer

Phase 1 & 2
Recruiting
Led By Grace Dy
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase II studies: Participant agrees to provide tumor biopsy tissue before treatment, blood samples at the start of treatment and at multiple times during the study and, a tumor biopsy at the end of the trial or after disease progression; archival formalin-fixed paraffin-embedded (FFPE) tissue is permitted for Expansion Cohort AE and Cohort D or E (i.e.; fresh biopsy is NOT mandatory). Archival FFPE tissue is also permitted for Study C patients provided that tissue is adequate and no systemic anti-cancer therapy had been administered between the time specimen was obtained and start of protocol therapy
Have pathologically confirmed diagnosis of NSCLC (Phase I, Phase II Studies A, C and D, E and Expansion Cohort) or squamous cell head and neck cancer (Phase II Study B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months from 5th vaccine dose
Awards & highlights

Study Summary

This trial is testing a combination of two cancer treatments - a vaccine and an immunotherapy drug - to see if they are more effective than either treatment alone in treating patients with non-small cell lung cancer or squamous head and neck cancer.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer or squamous head and neck cancer. Participants must have a life expectancy of at least 6 months, normal organ function, no recent chemotherapy, untreated brain metastases, or major surgery. They should not be pregnant and agree to use contraception. Those with certain autoimmune diseases or previous immunotherapy (with some exceptions) are excluded.Check my eligibility
What is being tested?
The trial is testing the CIMAvax vaccine combined with nivolumab or pembrolizumab to see if they can slow down tumor growth in patients better than current treatments. It's a phase I/II study which means it's looking at the best dose and side effects as well as how effective this combination could be.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking healthy cells leading to inflammation in various organs, infusion-related reactions from the drug entering your body, fatigue, potential changes in blood tests that monitor liver and kidney function, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to provide tissue and blood samples for the study.
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I have been diagnosed with either non-small cell lung cancer or squamous cell head and neck cancer.
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I can perform all self-care but may not be able to do heavy physical work.
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My liver enzymes are within acceptable limits.
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My kidney function, measured by creatinine or GFR, is within the normal range.
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I am eligible for nivolumab treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months from 5th vaccine dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months from 5th vaccine dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT) as graded by Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v. 4.03) (Phase I)
Overall survival (Phase II)
Progression-free survival (PFS) - Phase II
Secondary outcome measures
Incidence of adverse events (AEs) graded according to National Cancer Institute version 4.03 (NCI CTCAE v4.03) (Phase I and II)
Overall Survival (OS)
Progression free survival (PFS) based on immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) (Phase II)
Other outcome measures
Blood EGF levels, platelet levels, markers of immune response, and antibody functionality (Phase I and II)
EGFR and PD-1 expression and mutations in tumor tissue (Phase I and II)
Response assessed using irRECIST, immune-related Response Criteria (irRC), and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Phase I and II)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase II Study D (CIMAvax, pembrolizumab)Experimental Treatment3 Interventions
PHASE II STUDY D: Patients with PD-L1 expression < 50% after 4 cycles of induction chemotherapy with pembrolizumab, receive CIMAvax IM and pembrolizumab IV over 30 minutes. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Phase II Study C, D & E (CIMAvax, pembrolizumab)Experimental Treatment3 Interventions
PHASE II STUDY C, D & E: Patients with PD-L1 expression >= 50% receive CIMAvax IM and pembrolizumab IV over 30 minutes. Treatment with CIMAvax repeats every 2 weeks for 4 doses during the loading phase and every 4 weeks during the maintenance phase in the absence of disease progression or unacceptable toxicity. Courses for pembrolizumab repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group III: Phase II Study A and B (CIMAvax, nivolumab)Experimental Treatment3 Interventions
PHASE II STUDY A and B: Patients receive CIMAvax IM and nivolumab IV over 60 minutes. Treatment with CIMAvax repeats every 2 weeks for 4 doses during the loading phase and every 4 weeks during the maintenance phase in the absence of disease progression or unacceptable toxicity. Courses for nivolumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients in Study A with antibody titer >= 1:4000 at the end of the loading phase may receive CIMAvax IM every 8 or 12 weeks during the maintenance phase.
Group IV: Phase I (CIMAvax, nivolumab)Experimental Treatment3 Interventions
LOADING PHASE I: Patients receive CIMAvax IM and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 doses in the absence of disease progression or unacceptable toxicity. Within 4 weeks after the 4th dose, patients receive CIMAvax IM at the same time as the next nivolumab dose. MAINTENANCE PHASE I: Patients who do not experience a DLT receive CIMAvax every 4 weeks and nivolumab every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
400 Previous Clinical Trials
30,557 Total Patients Enrolled
Grace DyPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
21 Total Patients Enrolled
Prantesh Jain, MDPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

CIMAvax Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02955290 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Phase II Study A and B (CIMAvax, nivolumab), Phase II Study C, D & E (CIMAvax, pembrolizumab), Phase I (CIMAvax, nivolumab), Phase II Study D (CIMAvax, pembrolizumab)
Non-Small Cell Lung Cancer Clinical Trial 2023: CIMAvax Vaccine Highlights & Side Effects. Trial Name: NCT02955290 — Phase 1 & 2
CIMAvax Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02955290 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an overview of prior research exploring Laboratory Biomarker Analysis?

"Laboratory Biomarker Analysis was initially studied at City of Hope in 2010, and since then 1035 trials have been completed. Currently 1637 studies are active with a large portion taking place within Cleveland, Ohio."

Answered by AI

Are there multiple sites where this clinical research is managed?

"This research project has 5 sites of enrolment, including University Hospitals Cleveland Medical Center in Cleveland; Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis; as well as St. Francis Hospital in Roslyn, along with an additional 5 locations."

Answered by AI

Are there still vacancies in the research program?

"Data hosted on clinicaltrials.gov provides evidence that this medical trial is in the process of recruiting patients. It was first advertised on December 22nd 2016 and has been recently updated as of August 19th 2022."

Answered by AI

What conditions is Laboratory Biomarker Analysis typically employed to diagnose?

"Laboratory Biomarker Analysis is a popular treatment option for patients with unresectable melanoma, as well as microsatellite instability high and squamous cell carcinoma. In addition, it can be prescribed to treat transplantation-related conditions."

Answered by AI

What is the capacity of this trial in terms of participants?

"This trial necessitates 193 participants who fit the criteria. Potential enrollees will have the choice to join at University Hospitals Cleveland Medical Center in Cleveland and Indiana University Melvin and Bren Simon Comprehensive Cancer Centre in Indianapolis, Indiana."

Answered by AI
~81 spots leftby Dec 2027