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

Nasopharyngeal Cancer Clinical Trial

— NIVONASO-21  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875611
• Other study ID #: 20-NIO-0003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2021
• Source: Maria Sklodowska-Curie Institute - Oncology Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Opdivo
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).

Locations

Country	Name	City	State
Poland	Klinika Hematologii z Pododzialem Chorób Naczyn Uniwersyteckiego Szpitala Klinicznego w Bialymstoku	Bialystok
Poland	Klinika Hematologii i Transplantologii Gdanskiego Uniwersytetu Medycznego	Gdansk
Poland	Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Oddzial w Gliwicach	Gliwice
Poland	Klinika Hematologii i Transplantacji Szpiku, Swietokrzyskie Centrum Onkologii	Kielce

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Institute - Oncology Center	KCRI

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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); Complete response (CR)- disappearance of all target lesions and short dimension of all lymph nodes < 10 mm	12 weeks
Secondary	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	6 month of treatment phase
Secondary	Overall survival (OS) rate- time of total survival		at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up)
Secondary	DCR(disease control rate) per RECIST (Response Evaluation Criteria in Solid Tumours)	Defined as not meeting the criteria for progression and PR(partial response)	through study completion, an average of 6 months
Secondary	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.	through study completion, an average of 1 year
Secondary	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.		from first infusion to last follow up ( 3 month, 6 month, 9 month,12month follow up)
Secondary	Safety assessment of treatment with Nivolumab measured by excesive toxity		Each visit during treatment phase -12 cycles of investigation product's infusion (around 6 month of treatment).