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Monoclonal Antibodies
Nivolumab + Ramucirumab for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Hossein Borghaei, DO
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
A core tumor biopsy obtained after progression on the last treatment must be available at study entry for the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study Summary
This trial will enroll patients who have had IO therapy in the past, with the goal of seeing how well they respond to a combination of treatments.
Who is the study for?
Adults over 18 with advanced non-small cell lung cancer that's come back or spread, who've tried one treatment already. They need normal organ/marrow function and no major health issues like serious infections or heart problems. Women of childbearing age must test negative for pregnancy and agree to contraception, as should men with partners who can get pregnant.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs, Nivolumab plus Ramucirumab, in patients whose lung cancer has returned or spread. It's open to those previously treated with immunotherapy regardless of PD-L1 levels. The main goal is to see how well the disease is controlled with this drug combo.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding risks like nosebleeds or heavier menstrual periods, fatigue, potential immune system reactions affecting organs (like colitis), skin rash, and infusion-related reactions such as fever or chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I have a recent biopsy after my last treatment showed my cancer progressed.
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My lung cancer has come back or hasn't responded to treatment.
Select...
I have at least one tumor that can be measured.
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I have completed one round of treatment for my condition.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (DCR) in IO experienced patients.treated with nivolumab and ramucirumab combination therapy
Secondary outcome measures
Number of patients with treatment related toxicities in IO naive patients treated with nivolumab and ramucirumab combination therapy
Overall Response Rate (ORR)
Overall survival in IO experienced patients treated with nivolumab and ramucirumab combination.
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Patients with prior IO therapyExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,619 Previous Clinical Trials
3,206,559 Total Patients Enrolled
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,470 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,425 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.I am still recovering from my last cancer treatment.I am not currently taking any experimental drugs or immune system modifiers.I have severe liver disease or liver disease with serious complications.I have been treated with ramucirumab before.I have had severe GI bleeding in the last 3 months.I have had a blood clot in my veins, lungs, or another serious clot.I do not have any severe illnesses that could interfere with the study.I have not had severe side effects from previous immune therapy.I am older than 18 years.I have a recent biopsy after my last treatment showed my cancer progressed.I agree to use contraception since my partner can become pregnant.My blood pressure is very high and not well-managed.I have not coughed up blood in the last 2 months and my cancer hasn't invaded major blood vessels.My cancer returned within 6 months after platinum-based therapy or progressed after 6 months and another platinum treatment.My cancer has specific genetic changes and has not responded to targeted treatments.I am fully active or can carry out light work.My organ and bone marrow functions are normal.I have been on a stable dose of blood thinners for at least 14 days.My lung cancer has come back or hasn't responded to treatment.I have completed one round of treatment for my condition.I have had a blood clot in an artery in the last 6 months.I haven't had serious wounds, ulcers, or bone fractures in the last 28 days.I have had a previous GI perforation or fistula.I had major surgery less than 4 weeks before starting the treatment.I take 10mg or less of prednisolone daily.I am on a long-term blood thinner other than aspirin.I have interstitial lung disease or active noninfectious pneumonitis.I have not received a live vaccine in the last 30 days.I have at least one tumor that can be measured.I have not been treated with PD-1 or PD-L1 therapies.Your urine protein level should be low, as shown by a dipstick test or routine urinalysis.I do not have untreated brain metastases causing symptoms.You have an ongoing autoimmune disease that needed treatment in the past year.I have taken a pregnancy test within the last 3 days and it was negative.I have a chronic hepatitis B or C infection that is not cured.I am willing to use effective birth control.I have recovered from side effects of previous treatments, except for nerve issues or hair loss.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with prior IO therapy
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other experiments have been conducted to understand the effects of Nivolumab?
"At present, there are 762 active clinical trials for Nivolumab; 90 of them have reached the third phase. Although most tests take place around Basel, BE, 43128 locations across the world run studies for this drug."
Answered by AI
Is recruitment for this clinical experiment still ongoing?
"Affirmative. The details posted on clinicaltrials.gov indicate that this investigation is actively recruiting participants, with 39 people required to be enrolled at one location since the study was published on 8th October 2020 and modified most recently in April 2022."
Answered by AI
Are there any potential hazards associated with Nivolumab use?
"Data collected by our team at Power suggest that Nivolumab carries a risk-level of 2, as it is currently undergoing Phase 2 trials. This implies that while safety has been established to some degree, efficacy remains unproven."
Answered by AI
What medical conditions can Nivolumab be administered to alleviate?
"Melanoma, squamous cell carcinoma and other malignancies can be managed via the use of Nivolumab."
Answered by AI
Could you elucidate what is the upper threshold of participants in this experiment?
"Affirmative. According to the information accessible on clinicaltrials.gov, this medical trial is recruiting participants; it was first publicized on October 8th 2020 and latest updated April 6th 2022. The project requires 39 individuals to be recruited from 1 site."
Answered by AI
Is this a pioneering exploration into new medical territory?
"Nivolumab has been under medical evaluation since 2012, when Ono Pharmaceutical Co. Ltd performed a first trial involving 659 participants. Upon completion of the Phase 1 & 2 trials, Nivolumab was granted drug approval and has subsequently accumulated 762 active studies across 2427 cities in 50 countries worldwide."
Answered by AI
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