A Phase 1/2 interventional study of Nivolumab and GM.CD40L Vaccine in Lung Cancer and Adenocarcinoma of the Lung, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 1/2, Interventional, and Treatment
The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.
This study has two parts and participants may be involved in either Phase I part or Phase II.
Phase I: Investigators plan to enroll participants in cohorts of 6 and monitor side effects over a 21 day period to determine the maximum tolerated dose (MTD) of nivolumab, which will be given in combination with GM.CD40L. This is being done since this study involves a combination of treatments that have not been studied in humans before and to find the best dose for the Phase II part of the study.
Phase II: Investigators plan to compare any clinical benefit in the participants who receive the combination of GM.CD40L vaccine with nivolumab, to participants that receive only nivolumab.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
Browse Adenocarcinoma studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Exclusion Criteria:
Participants will receive nivolumab and GM.CD40L. Treatment will be administered on an outpatient basis. The nivolumab will be given first followed by the GM.CD40L vaccine for those enrolled on this arm.
Drug: Nivolumab · Biological: GM.CD40L Vaccine
Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.
Drug: Nivolumab
Participants will receive treatment with nivolumab as a 60-minute +/-5 minutes intravenous (IV) infusion on Day 1 and 15 of each 28-day cycle.
Also known as: Opdivo, Anti-PD-1
GM.CD40L will be injected intradermally every 2 weeks for 4 injections, then every month for 4 injections, then every 3 months until the patient is off treatment.
Also known as: Immunotherapy, Cell Vaccine
Phase I: Recommended Phase II Dose
The recommended Phase II dose will be defined as the highest dose level of GMCD40L vaccine in combination with nivolumab that induced dose limiting toxicity (DLT) in fewer than 33% of patients.
Time frame: Up to 2 months
Phase II: Objective Response Rate (ORR)
Objective tumor response per treatment arm. ORR: Complete Response (CR) = disappearance of all target lesions + Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions.
Time frame: Up to 2 years
Phase II: Overall Survival (OS)
OS per treatment arm. Overall survival is defined as the time from randomization until death from any cause.
Time frame: Up to 2 years
Phase II: Progression-free Survival (PFS)
PFS per treatment arm. Progressive Disease (PD): = 20% increase in the sum of the longest diameter of target lesions.
Time frame: Up to 2 years
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute