Phase II study evaluating the efficacy of Nivolumab in the treatment of patients with nasopharyngeal cancer who progressed during or after platinum-based chemotherapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Aug 2021 → ongoing

Decision date (initial)

2024-11-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Agency

External identifiers

EU CT number

2024-517479-19-00

EudraCT number

2020-005629-10

ClinicalTrials.gov

NCT04875611

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To evaluate efficacy of Nivolumab in the treatment of patients with nasopharyngeal cancer who progressed during or after platinum-based chemotherapy.

Secondary objectives 1

1. To evaluate safety and tolerance of Nivolumab in patients with nasopharyngeal cancer who proressed during or after platinum-based chemotherapy.

Conditions and MedDRA coding

Nasopharyngeal Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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 reccurence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
6. ECOG 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 19

1. Known active central nervous system metastases
2. Presence of renal insufficiency defined as eGFR < 30 ml/min/m2
3. 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
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 infection.
16. Patient received any live vaccine within 28 days before enrollment.
17. Heart Failure - NYHA 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR), defined as percentage of objective responses (partial and complete responses combined /PR + CR/ by iRECIST response criteria) in MRI after 12 weeks. a. Partial response (PR)- at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD b. Complete response (CR)- disappearance of all target lesions and short dimension of all lymph nodes < 10 mm

Secondary endpoints 7

1. Progression- free survival (PFS) by iRECIST criteria- from the beginning of treatment to the progression of disease or death. Progression will be evaluated in MRI (after 6 months of treatment phase) and defined according to iRECIST criteria.
2. 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)
3. DCR per RECIST (disease control rate)- defined as not meeting the criteria for progression and PR; measured in MRI from the start of the treatment until the criteria for disease progression is met.
4. DoR per RECIST (duration of response) – measured in MRI from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.
5. Change in quality of life in EORTC QLQ-C30 (version 3.0) from baseline to last infusion.
6. Change in quality of life in EORTC QLQ-C30 (version 3.0) - from baseline to last follow up.
7. Safety assessment of treatment with Nivolumab : • total rate of patient, who discontinues from infusion due to excesive toxicity, measured after end of treatment phase • time from start of treatment to occurrence of excesive toxicity preventing from continuation the infusion of Nivolumab, assessed at each visit during treatment phase.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Address

Ul. Wybrzeze Armii Krajowej 15

City

Gliwice

Postcode

44-102

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Clinical Research Support Center

Public contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Clinical Research Support Center

Third parties 1

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications