BridgeMD
Phase II study evaluating the efficacy of Nivolumab in the treatment of patients with nasopharyngeal cancer who progressed during or after platinum-based chemotherapy
EU CTIS ID: 2024-517479-19-00
What this study is testing
To evaluate efficacy of Nivolumab in the treatment of patients with nasopharyngeal cancer who progressed during or after platinum-based chemotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years old
- Histological or cytological documentation of squamous cell carcinoma
- Primary tumor location in nasopharynx
- Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy
- Tumor reccurence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
- ECOG performance scale 0-1
You likely can't join if
- Known active central nervous system metastases
- Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
- Patient is currently participating in another clinical trial.
- Active infection, which significantly affects the patient's clinical condition and requires treatment.
- Patient with prior bone marrow or solid organ transplantation.
- Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent > 10 mg)
See the full eligibility criteria
- Age > 18 years old
- Histological or cytological documentation of squamous cell carcinoma
- Primary tumor location in nasopharynx
- Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy
- Tumor reccurence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
- ECOG performance scale 0-1
- 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.
- Known active central nervous system metastases
- Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
- Patient is currently participating in another clinical trial.
- Active infection, which significantly affects the patient's clinical condition and requires treatment.
- Patient with prior bone marrow or solid organ transplantation.
- Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent > 10 mg)
- Known immunodeficiency including HIV/AIDS infection.
- Patient received any live vaccine within 28 days before enrollment.
- Heart Failure - NYHA III or IV
- 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.
- Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.
- Presence of renal insufficiency defined as eGFR < 30 ml/min/m2
- Presence of liver disfunction, defined as level of AST and /or ALT > 2,5 x ULN (> 5 x ULN in patients with documented liver metastases); total bilirubin > 1,5 x ULN ( bilirubin > 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%) or albumin < 2,5 g/dL
- Abnormalities in blood count such as: hemoglobin < 9 g/dl, platelets < 100 x 109 /L, Absolute Neutrophil Count (ANC) <1,0 x 109 /L
- Ejection fraction in echocardiography < 50%
- History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.
- Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.
- Pregnancy or breastfeeding.
- 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)
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.