NCT03527108

Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLC

A Phase 2 Study of Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic Non-Small Cell Lung Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	The treatment will be given on a 28-day cycle, with doses of nivolumab and ramucirumab given on days 1 and 15. The dose of nivolumab will be fixed at 240 mg. Nivolumab should be administered first, followed by premedication, and then ramucirumab. Ramucirumab should be administered approximately 30 minutes after premedication
DRUG	Ramucirumab	The treatment will be given on a 28-day cycle, with doses of nivolumab and ramucirumab given on days 1 and 15. The dose of ramucirumab will depend upon the patient weight as noted below. Nivolumab should be administered first, followed by premedication, and then ramucirumab. Ramucirumab should be administered approximately 30 minutes after premedication

Timeline

• Start date: 2020-10-08
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2018-05-16
• Last updated: 2026-01-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study