AzTrials
AzTrials

Nasopharyngeal CancerPhase 2NIVONASO-21NCT04875611

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

A Phase 2 study testing Opdivo in people with Nasopharyngeal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 4 sites in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasopharyngeal Cancer
What is being tested?
Opdivo
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
4 sitesPoland
Study dates
26 Aug 2021to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
  • ECOG(Eastern Cooperative Oncology Group) 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.

Who cannot join

  • Known active central nervous system metastases.
  • Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) < 30 ml/min/m2
  • 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
  • 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.
Show all 19Show fewer
  • 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)
  • 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(human immunodeficiency virus/acquired immunodeficiency syndrome) infection.
  • Patient received any live vaccine within 28 days before enrollment.
  • Heart Failure - NYHA(New York Heart Association functional classification system) 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Poland4 sites, 4 recruiting

  • Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku

    Bialystok

    Ewa Sierko, dr hab.n. med., 856646720, esierko@onkologia.bialystok.pl

    Recruiting

  • Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego

    Gdansk

    Rafał Dziadziuszko, Prof.dr hab.n.med., 585844510, rafald@gumed.edu.pl

    Recruiting

  • Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach

    Gliwice, 44-101

    Tomasz Rutkowski, Dr hab. n.med., 604077641, Tomasz.rutkowski@io.gliwice.pl

    Recruiting

  • Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii

    Kielce

    Piotr Kędzierawski, dr n. med., 413674740, piotrkedzierawski@wp.pl

    Recruiting

Other trials in Poland

About this study

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

Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32.

Being tested
Opdivo
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OpdivoDrug

    Also called Nivolumab

    Dose of Nivolumab is constant and is 240 mg .All patients will undergo maximum of 12 cycles of investigation product's infusion ( around 6 month of treatment).Each cycle will be done in intervals of 14 day (no less than 12 days after previous infusion and no longer than 42 day/6 weeks after previous infusion).

Study groups in NCT04875611
Study groupRoleWhat they receive
Experimental therapy:OPDIVO (Nivolumab)ExperimentalNot described
Receives: Drug: Opdivo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Percentage of objective responses (partial and complete responses combined /partial response (PR)+ complete response(CR)/ by immune Response Evaluation Criteria in Solid Tumours (iRECIST) response criteria) in MRI (Magnetic Resonance Imaging) after 12 weeks.

    1. Partial response - at least a 30% decrease in the sum of the LD(longest diameter) of target lesions, taking as reference the baseline sum LD(longest diameter)
    2. Complete response (CR)- disappearance of all target lesions and short dimension of all lymph nodes < 10 mm

    Measured: 12 weeks

Secondary outcomes (6)

  1. 1.Progression- free survival (PFS) by iRECIST( immune Response Evaluation Criteria in Solid Tumours) criteria- from the beginning of treatment to the progression of disease or death.

    Progression will be evaluated in MRI(Magnetic Resonance Imaging) and defined according to iRECIST(immune Response Evaluation Criteria in Solid Tumours) criteria:

    • least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm.
    • the appearance of one or more new lesions

    Measured: 6 month of treatment phase

  2. Overall survival (OS) rate- time of total survival

    Measured: at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up)

  3. DCR(disease control rate) per RECIST (Response Evaluation Criteria in Solid Tumours)

    Defined as not meeting the criteria for progression and PR(partial response)

    Measured: through study completion, an average of 6 months

  4. DoR(duration of response) per RECIST (Response Evaluation Criteria in Solid Tumours)

    Measured in MRI(Magnetic Resonance Imaging) from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.

    Measured: through study completion, an average of 1 year

  5. Change in quality of life in EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) (version 3.0) .A high scale score represents a higher response level.

    Measured: from first infusion to last follow up ( 3 month, 6 month, 9 month,12month follow up)

  6. Safety assessment of treatment with Nivolumab measured by excesive toxity

    Measured: Each visit during treatment phase -12 cycles of investigation product's infusion (around 6 month of treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start26 Aug 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875611
Sponsor's protocol ID
20-NIO-0003
Acronym
NIVONASO-21
Status last verified
Oct 2026
First submitted
25 Apr 2021
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Opdivo in people with Nasopharyngeal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 4 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in