Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 5:46 PM
Study NCT ID:
NCT03527108
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2018-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLC
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
A Phase 2 Study of Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic Non-Small Cell Lung Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will enroll patients with prior IO therapy (alone or in combination with chemotherapy or in combination with other IO agents) regardless of the PD-L1 level, into a non-randomized combination trial, with primary endpoint of disease control rate.
Detailed Description:
Immunotherapeutic treatment with check-point inhibitors has increased survival in patients with advanced non-small cell lung cancer (NSCLC) that does not have any mutation to be targeted. However, the concept that tumors evade immune surveillance through a variety of mechanisms, and that activating the immune system can lead to tumor regression in a variety of tumor types has been known for decades. Thus, this study combines the effects to blocking 2 different pathways- inhibition of PD-1 pathway and angiogenic pathway via inhibition of VEGR signaling to improve survival as blocking each pathway individually has demonstrated a modest increment. There has been no study using nivolumab in combination with a VEGFR2 inhibitor, a drug which has both anti-angiogenic and pleotropic immunomodulatory effects and may synergize with the effect of an anti-PD-1 agent, in solid tumors. Activating the anti-tumor effects of T cells by utilizing multiple pathways of both nivolumab and ramucirumab is an endeavor which merits investigation.
Thus, the study investigates the synergistic effect of targeted anti-antitumor activity of immune checkpoint inhibitor nivolumab and immune-suppressive activity of VEGF-inhibitor ramicirumab expecting a favorable overall survival in NSCLC patients, with the additional benefit of tolerable toxicities.
Thus, the study investigates the synergistic effect of targeted anti-antitumor activity of immune checkpoint inhibitor nivolumab and immune-suppressive activity of VEGF-inhibitor ramicirumab expecting a favorable overall survival in NSCLC patients, with the additional benefit of tolerable toxicities.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TH-189 | OTHER | Fox Chase Cancer Center | View |