Nivolumab treatment for nasopharyngeal cancer after platinum therapy

Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy

This study is testing if Nivolumab, an immunotherapy drug, can help people with nasopharyngeal cancer who haven't responded to platinum chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, Nivolumab
• Locations: 4 sites (Bialystok and 3 other locations)
• Trial ID: NCT04875611 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of Nivolumab, an immunotherapy drug, in patients with nasopharyngeal cancer who have experienced disease progression during or after platinum-based chemotherapy. It is a multicenter, non-randomized, prospective trial aiming to enroll 32 patients who are not candidates for radical therapy. Participants must have documented squamous cell carcinoma of the nasopharynx and meet specific inclusion criteria related to their treatment history and overall health status.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with squamous cell carcinoma of the nasopharynx who have progressed on or after platinum-based chemotherapy.

Not a fit: Patients with active central nervous system metastases or significant renal or liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with nasopharyngeal cancer who have limited treatment choices after failing platinum-based chemotherapy.

How similar studies have performed: Other studies have shown promising results with Nivolumab in various cancers, suggesting potential success with this approach in nasopharyngeal cancer.

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.

Where this trial is running

Bialystok and 3 other locations

• Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku — Bialystok, Poland (Recruiting)
• Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego — Gdansk, Poland (Recruiting)
• Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach — Gliwice, Poland (Recruiting)
• Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii — Kielce, Poland (Recruiting)

Conditions Nasopharyngeal Cancer