Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment

Launched by MARIA SKLODOWSKA-CURIE NATIONAL RESEARCH INSTITUTE OF ONCOLOGY · May 3, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Nivolumab for patients with nasopharyngeal cancer, a type of cancer that affects the area behind the nose and above the throat. Specifically, the trial focuses on patients whose cancer has progressed or worsened during or after receiving platinum-based chemotherapy, which is a common treatment for this type of cancer. The goal is to see how effective Nivolumab is for these patients, especially for those who cannot have more aggressive treatments like surgery or radiation.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma located in the nasopharynx. They should have experienced treatment failure or disease progression during platinum-based chemotherapy, and their overall health must be stable enough to participate. Throughout the trial, participants will receive the study treatment and will be monitored closely for any side effects or changes in their condition. It’s important to note that this trial is not yet recruiting, so interested individuals will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years old
• • 2. Histological or cytological documentation of squamous cell carcinoma.
• • 3. Primary tumor location in nasopharynx
• • 4. Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy
• • 5. Tumor recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
• • 6. ECOG(Eastern Cooperative Oncology Group) performance scale 0-1
• • 7. Participant is willing and able to give informed consent for participation in the study and agrees to undergo all follow up visit and planned procedures.
• Exclusion Criteria:
• • 1. Known active central nervous system metastases.
• • 2. Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) \< 30 ml/min/m2
• • 3. Presence of liver disfunction, defined as level of AST(aspartate aminotransferase) and /or ALT(alanine aminotransferase) \> 2,5 x ULN(upper limits of normal) (\> 5 x ULN in patients with documented liver metastases); total bilirubin \> 1,5 xULN ( bilirubin \> 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35%) or albumin \< 2,5 g/dL
• • 4. Abnormalities in blood count such as: hemoglobin \< 9 g/dl, platelets \< 100 x 109 /L, Absolute Neutrophil Count (ANC) \<1,0 x 109 /L
• • 5. Ejection fraction in echocardiography \< 50%
• • 6. History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.
• • 7. Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.
• • 8. Pregnancy or breastfeeding.
• • 9. Female with childbearing potential or male participant with female partner of childbearing potential, who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period and for 5 months after the end of treatment (last infusion)
• • 10. Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
• • 11. Patient is currently participating in another clinical trial.
• • 12. Active infection, which significantly affects the patient's clinical condition and requires treatment.
• • 13. Patient with prior bone marrow or solid organ transplantation.
• • 14. Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent \> 10 mg)
• • 15. Known immunodeficiency including HIV/AIDS(human immunodeficiency virus/acquired immunodeficiency syndrome) infection.
• • 16. Patient received any live vaccine within 28 days before enrollment.
• • 17. Heart Failure - NYHA(New York Heart Association functional classification system) III or IV
• • 18. Coexistence of active malignant tumor or history of malignant tumor after radical treatment with disease-free period \> 2 years, except: cervical cancer in situ/ basocellular skin cancer/prostate cancer, after radical treatment.
• • 19. Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.