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| ID | Type | Description | Link |
|---|---|---|---|
| 1504-1392 | Other Identifier | NIH Office of Biotechnology Activities (OBA) |
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Funding unavailable
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I and Phase II Treatment Arm | Experimental | 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. |
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| Phase II Control Arm | Active Comparator | Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Overall Survival (OS) | OS per treatment arm. Overall survival is defined as the time from randomization until death from any cause. | Up to 2 years |
| Phase II: Progression-free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jhanelle Gray, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D009362 | Neoplasm Metastasis |
| D008171 | Lung Diseases |
| D000230 | Adenocarcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000711728 | spartalizumab |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| GM.CD40L Vaccine | Biological | 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. |
|
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PFS per treatment arm. Progressive Disease (PD): = 20% increase in the sum of the longest diameter of target lesions.
| Up to 2 years |
| D012140 |
| Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |