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New treatment option for Nasopharyngeal Carcinoma
Official title Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT06019130
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for nasopharyngeal carcinoma.
Also referred to as Opdivo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged...
- Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients \> 25 years of age (AJCC, 8th edition)
- Measurable disease by MRI per RECIST 1.1 criteria
- Sufficient tumor tissue to be sent for central review, including PD-L1 staining, either as 1 or 2 full blocks (preferred) or a minimum of 25 slides...
- Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation
You likely can't join if
- Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients \> 25 years of age
- Recurrent nasopharyngeal carcinoma
- Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- Prior chemotherapy and/or radiotherapy
- Other active malignancy
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell...
See the full eligibility criteria
- Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged between 3 years and 17 years, OR histologically confirmed new diagnosis of...
- Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients \> 25 years of age (AJCC, 8th edition)
- Measurable disease by MRI per RECIST 1.1 criteria
- Sufficient tumor tissue to be sent for central review, including PD-L1 staining, either as 1 or 2 full blocks (preferred) or a minimum of 25 slides, obtained from core biopsy, punch biopsy, excisional biopsy or surgical...
- Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation
- Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients \> 25 years of age
- Recurrent nasopharyngeal carcinoma
- Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- Prior chemotherapy and/or radiotherapy
- Other active malignancy
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- The subject received an investigational drug within 30 days prior to inclusion into this study
- people who are enrolled in another clinical trial
- people with prior organ allograft or allogenic bone marrow transplantation
- people with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before start of therapy. Inhaled or topical...
- Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values:
- WBC \< 2 000/µl
- Neutrophils \< 1 500/µl
- Platelets \< 100 x 10e3/µL
- Hemoglobin \< 9.0 g/dL
- Creatinine \>1.5 x ULN or creatinine clearance \< 50 mL/min (using the Cockcroft Gault formula or Schwartz formula in patients \< 18 years)
- AST/ALT \> 3 x ULN (\> 5 x ULN if liver metastases)
- Total Bilirubin \> 1.5 x ULN (except people with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 x ULN)
- Hearing loss \> 20 dB loss at 3 kHz due to an inner ear disorder and not caused by tumour burden
- History of allergy or hypersensitivity to platinum-containing compounds or other study drug components
- Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
- Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug.
- Adequate performance status (Karnofsky score ≥ 60 for patients (age ≥ 16), Lansky score ≥ 60 (age \< 16).
- The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
- The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
- Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol. (Please refer...
- Lactating females
- people, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- The subject is unwilling or unable to follow the procedures outlined in the protocol
- The subject is mentally or legally incapacitated.
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Berlin, Germany
- Bielefeld, Germany
- Bonn, Germany
- Cologne, Germany
- Cottbus, Germany
- Dortmund, Germany
- Dresden, Germany
- Erlangen, Germany
- Essen, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Giessen, Germany
- Göttingen, Germany
- Greifswald, Germany
- Halle, Germany
- Hamburg, Germany
- Jena, Germany
- Kiel, Germany
- Magdeburg, Germany
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Berlin, Germany; Bielefeld, Germany; Bonn, Germany; Cologne, Germany; Cottbus, Germany and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.