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NK/T Cell LymphomaPhase 1NCT04230330

Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma

A Phase 1 study testing IV Nivolumab, IV Gemcitabine and IV Cisplatin in people with NK/T Cell Lymphoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a pilot study investigating the role of nivolumab, a PD-1 inhibitor, in the treatment of advanced stage or relapsed/refractory NKTL. Patients who have received PD-1 inhibitors will be excluded from this study. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
NK/T Cell Lymphoma
What is being tested?
IV Nivolumab, IV Gemcitabine and IV Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSingapore
Study dates
12 Dec 2019to 12 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Subjects must have signed and dated and IRB-approved written consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study
  • Target population
  • All subjects must have histologically confirmed extranodal natural-killer/T-cell lymphoma (NKTL)
  • Subjects must have
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  • previously untreated stage III or IV NKTL, OR
  • relapsed/refractory NKTL who has received at least 2 cycles of one prior regimen or previous radiotherapy administered with curative intent and one of the following:
  • Failed to achieve at least a partial response
  • Failed to achieve a complete response at the end of planned therapy with curative intent
  • Progressed after initial response
  • Age ≥ 21 years
  • ECOG Performance status 0 - 2
  • Subjects must have laboratory test results within these ranges:
  • Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
  • Platelet count ≥ 75 x10^9/L
  • Creatinine clearance ≥ 40ml/min
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN). Higher levels are acceptable if these can be attributed to active haemolysis or ineffective erythropoiesis
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x ULN
  • Women of childbearing potential (WOCBT) must agree to use dual methods of contraception and have a negative serum or urine pregnancy test prior study treatment. Male patients must use an effective barrier method of contraception if sexually active with a WOCBT
  • Men and women of all ethnic groups are eligible for this study

Who cannot join

  • Previous treatment with an anti PD-1, anti PD-L1, anti PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Previous GDP therapy
  • Previous serious hypersensitivity reaction or symptomatic pancreatitis from L-asparaginase
  • Uncontrolled central nervous (CNS) disease
  • Uncontrolled hepatitis B or C
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
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  • All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug
  • Subjects with > grade 1 peripheral neuropathy
  • Any serious or uncontrolled medical disorder, autoimmune disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration or would impair the ability fo the subject to receive the study drug
  • Subjects who have had prior malignancies (other than NKTL) for ≤5 year with exception of currently treated basal cell, squamous cell carcinoma of the skin or carcinoma "in situ" of the cervix or breast.
  • Subjects who have had other anti-cancer therapy including radiation or experimental drug therapy within 28 days of enrollment
  • Subjects with known allergies or hypersensitivities to the study drugs
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
  • Pregnant women or women who are breastfeeding are excluded from this study

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Centre Singapore

    Singapore

Other trials in Singapore

About this study

Official title: A Pilot Study of Nivolumab in Combination With GDP (Gemcitabine, Dexamethasone, Cisplatin)/ L-asparaginase in Patients With Advanced Stage or Relapsed/ Refractory Natural-killer/ T-cell Lymphoma

This is a pilot study investigating the role of nivolumab, a PD-1 inhibitor, in the treatment of advanced stage or relapsed/refractory NKTL. Patients who have received PD-1 inhibitors will be excluded from this study.

Patients who have a complete response or good partial response to nivolumab during initial phase will continue to be treated with nivolumab. Patients who have a partial response, stable disease, and progressive disease to nivolumab during initial phase will be treated with the combination of nivolumab and GDP/L-asparaginase.

Being tested
IV Nivolumab, IV Gemcitabine, IV Cisplatin, IV/PO Dexamethasone, IV L-asparaginase
Medical subject headings
Lymphoma, Extranodal NK-T-Cell

What participants receive

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

  • IV NivolumabDrug

    Also called Opdivo

    240mg every 2 weeks.

  • IV NivolumabDrug

    Also called Opdivo

    Initial treatment dose is 240mg every 2 weeks for 4 doses. Dose changes to 360mg every 3 weeks when given with GDP/L-aspa. Maintenance treatment dose is 240mg every 2 weeks.

  • IV GemcitabineDrug

    800mg/m2 on Days 1 and 8 every 21 days

  • IV CisplatinDrug

    20mg/m2 on Day 1 to 4 every 21 days

  • IV/PO DexamethasoneDrug

    10mg on Days 1 to 4 every 21 days

  • IV L-asparaginaseDrug

    6000 Units/m2 on Days 2 to 8 every 21 days

Study groups in NCT04230330
Study groupRoleWhat they receive
NivolumabExperimentalAfter 4 doses of nivolumab, if the patient has complete responses (CR) or good partial response (PR), the patient will continue on nivolumab until disease progression, unacceptable toxicities, or discontinuation of treatment. During PET4-directed treatment with single agent nivolumab, if patient has PD, they will proceed to the Nivo+GDP/L-aspa arm.
Receives: Drug: IV Nivolumab
Nivolumab + GDP/ L-asparaginaseExperimentalAfter 4 doses of nivolumab, if the patient has PR, stable disease (SD), or progressive disease (PD), the patient will switch to nivolumab-GDP/L-aspa treatment. After 6 cycles of treatment, if CR is achieved, the patient will continue on single agent nivolumab until disease progression, unacceptable toxicities, or discontinuation of treatment.
Receives: Drug: IV Nivolumab; Drug: IV Gemcitabine; Drug: IV Cisplatin; Drug: IV/PO Dexamethasone; Drug: IV L-asparaginase

What is being measured

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

  1. Number of patients with complete response and partial response to treatment

    To calculate best overall response rate

    Measured: 6 months after the start of treatment

  2. Number of incidences of grade 3-5 non-haematological adverse events

    To calculate the toxicity rate of the treatment

    Measured: From start of first treatment to 100 days after last treatment dose

Secondary outcomes (5)

  1. Progression-free survival

    Measured: From start of treatment to date of disease progression or death, up to 2.5 years

  2. Overall survival

    Measured: From the start of treatment to date of death from any cause, up to 2.5 years

  3. Number of patients with complete response and partial response to single agent nivolumab

    To calculate the overall response rate of single agent nivolumab

    Measured: 6 months after the start of treatment

  4. Number of patients with complete response and partial response to nivolumab in combination with GDP/L-asparaginase

    Measured: 6 months after the start of treatment

  5. Number of incidences of adverse events

    To calculate the rate of adverse events from nivolumab with or without GDP/L-asparaginase

    Measured: From start of first treatment to 100 days after last treatment dose

Timeline

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

  1. First posted18 Jan 2020
  2. Study start12 Dec 2019
  3. Primary completion12 Jun 2020
  4. Study completion12 Jun 2020

Why it stopped: PI has left the institution.

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04230330
Sponsor's protocol ID
CA209-8R6
Status last verified
Nov 2020
First submitted
13 Jan 2020
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li X, Cheng Y, Zhang M, Yan J, Li L, Fu X, Zhang X, Chang Y, Sun Z, Yu H, Zhang L, Wang X, Wu J, Li Z, Nan F, Tian L, Li W, Young KH. Activity of pembrolizumab in relapsed/refractory NK/T-cell lymphoma. J Hematol Oncol. 2018 Jan 31;11(1):15. doi: 10.1186/s13045-018-0559-7.

    PubMed 29386072

  • Kwong YL, Chan TSY, Tan D, Kim SJ, Poon LM, Mow B, Khong PL, Loong F, Au-Yeung R, Iqbal J, Phipps C, Tse E. PD1 blockade with pembrolizumab is highly effective in relapsed or refractory NK/T-cell lymphoma failing l-asparaginase. Blood. 2017 Apr 27;129(17):2437-2442. doi: 10.1182/blood-2016-12-756841. Epub 2017 Feb 10.

    PubMed 28188133

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IV Nivolumab, IV Gemcitabine and IV Cisplatin in people with NK/T Cell Lymphoma, run by National Cancer Centre, Singapore at 1 site in Singapore.

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 21 inclusion and 15 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: withdrawn, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with complete response and partial response to treatment (time frame: 6 months after the start of treatment). The study lists 2 primary outcomes in all. 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 NCT04230330, which also lists 2 linked publications.

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 5 Nov 2020.

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