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Alkylating agents
Nivolumab for Nasopharyngeal Cancer
Phase 3
Waitlist Available
Led By Brigette B Ma
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death due to any cause or last follow-up. analysis occurs after 200 deaths have been reported, assessed up to 8 years
Awards & highlights
Study Summary
This trial is testing adding nivolumab (immunotherapy) to the usual chemotherapy (cisplatin or carboplatin with gemcitabine) to treat nasopharyngeal cancer.
Eligible Conditions
- Nasopharyngeal Carcinoma
- Nasopharyngeal Cancer
- Nasopharyngeal Undifferentiated Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until death due to any cause or last follow-up. analysis occurs after 200 deaths have been reported, assessed up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death due to any cause or last follow-up. analysis occurs after 200 deaths have been reported, assessed up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Distant metastases
Fatigue
Incidence of adverse events (AEs)
+6 moreOther outcome measures
Change in fatigue
Change in quality of life
Overall survival by PD-L1 CPS/TPS cut-off
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (gemcitabine, cisplatin, carboplatin)Active Control4 Interventions
Patients receive gemcitabine and cisplatin or carboplatin as in Arm I.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine
2017
Completed Phase 3
~2070
Nivolumab
2014
Completed Phase 3
~4750
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
231 Previous Clinical Trials
100,837 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,667 Total Patients Enrolled
Brigette B MaPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test shows that you have enough white blood cells called neutrophils (ANC) which is at least 1500 cells per cubic millimeter within the past 14 days before the study.Your platelet count must be at least 100,000 cells per cubic millimeter within 14 days before enrolling in the study.You have had a check-up by a cancer specialist within the past two weeks.You had a lung inflammation in the past that needed treatment with steroids or immunosuppressive medication.You need to have had a CT scan taken of your chest, abdomen, and pelvis no longer than 30 days before joining the study.You have had a special type of imaging test called a contrast-enhanced MRI or CT scan of your neck and nasopharynx within the past 30 days.You have a serious, ongoing health condition.Your hemoglobin level should be at least 9.0 g/dL, which can be checked with a blood test taken up to 14 days before the trial. If you need a blood transfusion, that's okay, but you can't be dependent on erythropoietin.You have been diagnosed with NPC and the cancer has come back either in the same area or has spread elsewhere in your body. If it has come back in the same area, it cannot be treated with surgery or radiation. The cancer can be of two types: keratinizing (squamous cell carcinoma) or non-keratinizing (undifferentiated or poorly differentiated).You have a tumor that can be measured using a specific set of guidelines. If you had radiation treatment before, the tumor can still be measured as long as it has grown since then.You can perform daily activities without any difficulty or with some mild limitations due to your medical condition.Your bilirubin levels (a substance in your blood) cannot be too high, unless you have Gilbert's Syndrome which has been diagnosed in the past 14 days.You have an autoimmune disease that requires ongoing treatment with medication.You have been diagnosed with another type of cancer within the last 3 years.You have received an organ or bone marrow transplant in the past.You are currently pregnant or breastfeeding.You have received a live vaccine in the 30 days before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)
- Group 2: Arm II (gemcitabine, cisplatin, carboplatin)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total patient population in this clinical trial?
"Unfortunately, this trial is not looking for more participants at the moment. The listing was created on September 8th, 2020 and was last updated 23rd September, 2022. However, there are 3527 trials for nasopharynx and 2153 trials for Questionnaire Administration that are currently enrolling patients."
Answered by AI
How does the level of risk for patients change when completing a questionnaire?
"There is some evidence from earlier trials to support the safety of Questionnaire Administration, as well as multiple rounds of data from Phase 3 trials. This earns it a score of 3."
Answered by AI
Do other research teams use questionnaires to collect data?
"Questionnaire Administration was first trialed in 1997 at City of Hope Comprehensive Cancer Center. So far, there have been 2672 completed studies related to this topic. Additionally, there are 2153 live clinical trials, a large number of which are based in Joplin, Missouri."
Answered by AI
Why do people often take Questionnaire Administration?
"Questionnaire Administration is a versatile treatment that can be used to improve urinary bladder function and to target small cell lung cancer (sclc), advanced testicular cancer, and other malignant neoplasms."
Answered by AI
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