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Cancer Vaccine

Dendritic Cell based p53 Vaccine for Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Alberto Chiappori, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will last for approximately two years.

Eligible Conditions
  • Small Cell Lung Cancer Relapse
  • Lung Cancer
  • Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control Rate (DCR)
Secondary outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination Immunotherapy Plus VaccineExperimental Treatment3 Interventions
Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell based p53 Vaccine (Ad.p53-DC). Induction Immunotherapy, followed by Maintenance Immunotherapy and potentially Retreatment. During retreatment, participants would receive the combination of Ipilimumab and Nivolumab or Nivolumab alone every three weeks for a maximum of one additional year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,478 Total Patients Enrolled
MultiVir, Inc.Industry Sponsor
2 Previous Clinical Trials
44 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,018 Total Patients Enrolled

Frequently Asked Questions

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

To which diseases is Dendritic Cell based p53 Vaccine commonly prescribed?

"Anti-angiogenic therapy is often treated with a Dendritic Cell based p53 Vaccine, which has also been proven to be useful for malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

What precedent has been established with regards to the Dendritic Cell based p53 Vaccine?

"Currently, 765 medical trials for Dendritic Cell based p53 Vaccine are underway with 86 of them in the third phase. Pittsburgh is a major site but 42755 other centres globally are also conducting research into this vaccine."

Answered by AI

How many individuals are being enrolled in this research program?

"Recruitment for this trial has already concluded. It was posted on March 15th 2018 and the last update occurred on May 13th 2022. If you're searching for other studies, there are 1,715 lung cancer trials actively recruiting patients as well as 765 clinical trials searching for participants to test a p53 Vaccine delivered through dendritic cells."

Answered by AI

Has the Dendritic Cell based p53 Vaccine obtained authorization from the Federal Drug Administration?

"Our team at Power gave a score of 2 for the safety profile of Dendritic Cell based p53 Vaccine, as it is currently in Phase 2 trials and has yet to gather data on its efficacy."

Answered by AI

Does this experiment currently accept new participants?

"According to the information on clinicaltrials.gov, this study has closed its recruitment process after initially posting it back in March 15th 2018 and editing it lastly on May 13th 2022. However, there are 2,480 other trials actively needing participants at present time."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
H. Lee Moffitt Cancer Center and Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)
2018. "Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03406715.
~2 spots leftby Apr 2025
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