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

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Brief Title

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

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

Brief 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.

      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.

Study Phase

Phase 1

Study Type


Primary Outcome

Number of patients with complete response and partial response to treatment

Secondary Outcome

 Progression-free survival


NK/T Cell Lymphoma


IV Nivolumab

Study Arms / Comparison Groups

Description:  After 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.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 12, 2019

Completion Date

June 12, 2020

Primary Completion Date

June 12, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  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

                    -  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

                    -  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

        Exclusion Criteria:

          -  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

          -  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)

          -  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

        Inclusion of women and minorities:

        Men and women of all ethnic groups are eligible for this study




21 Years - 80 Years

Accepts Healthy Volunteers



Tiffany Tang, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

National Cancer Centre, Singapore


 Bristol-Myers Squibb

Study Sponsor

Tiffany Tang, MD, Principal Investigator, National Cancer Centre, Singapore

Verification Date

November 2020