Clinical trial · Interventional
Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM.CD40L Vaccine | Biological | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I and Phase II Treatment Arm
- description
- 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.
- interventionNames
- Drug: Nivolumab
- Biological: GM.CD40L Vaccine
- type
- ACTIVE_COMPARATOR
- label
- Phase II Control Arm
- description
- Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.
- interventionNames
- Drug: Nivolumab
Primary outcomes (2)
- measure
- Phase I: Recommended Phase II Dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung * Eastern Cooperative Oncology Group (ECOG) performance status of 0/1 * Chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung cancer (NSCLC) \>6 months prior * Adequate bone marrow, renal and hepatic function * Must have measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria * Mandatory archival tissue or willingness to undergo a fresh biopsy * Life expectancy of greater than 6 months Exclusion Criteria: * Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis * Pregnancy or breast feeding * Serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment * Prior use of a PD1 or PDL1 inhibitor * Concurrent use of other anticancer approved or investigational agents is not allowed * Autoimmune disorders * Prior malignancy in past 2 years * Systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent * Any other pre-existing immunodeficiency condition (including known HIV infection)
References
Publications (0)
Data not yet available