NCT03075553

Brief Summary

This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

March 1, 2017

Results QC Date

April 2, 2020

Last Update Submit

April 20, 2020

Conditions

Blastic Plasmacytoid Dendritic Cell NeoplasmHepatosplenic T-Cell LymphomaHTLV-1 InfectionNK-Cell Lymphoma, UnclassifiablePrimary Systemic Anaplastic Large Cell Lymphoma, ALK-NegativeRecurrent Adult T-Cell Leukemia/LymphomaRecurrent Anaplastic Large Cell LymphomaRecurrent Angioimmunoblastic T-cell LymphomaRecurrent Enteropathy-Associated T-Cell LymphomaRecurrent Mycosis FungoidesRefractory Adult T-Cell Leukemia/LymphomaRefractory Anaplastic Large Cell LymphomaRefractory Angioimmunoblastic T-cell LymphomaRefractory Enteropathy-Associated T-Cell LymphomaRefractory Mycosis FungoidesRefractory Nasal Type Extranodal NK/T-Cell LymphomaRefractory Peripheral T-Cell Lymphoma, Not Otherwise Specified

Outcome Measures

Primary Outcomes (1)

  • Response Rate for Participants Who Achieve a CR or PR [CT-based Response]

    The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to \<=1.5 cm in longest transverse diameter (LDi). Partial response (PR): \>= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.

    Up to 390 days

Secondary Outcomes (5)

  • Response Rate for Participants Who Achieve a CMR or PMR [PET-CT-based Response]

    Up to 390 days

  • Duration of Response (DOR)

    Up to 390 days

  • Progression-Free Survival (PFS)

    The time from registration to relapse or death due to any cause, an average of 2 years

  • Overall Survival (OS)

    The time from registration to death due to any cause, assessed up to 2 years

  • Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events

    Up to 390 days

Study Arms (1)

Treatment (nivolumab)

EXPERIMENTAL

Patients receive nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisBiological: Nivolumab

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (nivolumab)
NivolumabBIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo
Treatment (nivolumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or refractory T-cell lymphoma (TCL) biopsy-proven =\< 6 months prior to registration, including the following subtypes:
  • Peripheral T-cell lymphoma, not otherwise specified
  • Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK) negative, primary systemic type
  • Angioimmunoblastic T-cell lymphoma
  • Extranodal natural killer (NK)/T-cell lymphoma, nasal type
  • Adult T-cell lymphoma/leukemia (human T-lymphotropic virus 1 \[HTLV1\]+)
  • Blastic NK-cell lymphoma
  • Enteropathy-associated T-cell lymphoma
  • Hepatosplenic gamma delta T-cell lymphoma
  • Transformed mycosis fungoides
  • T/NK-cell lymphoma, unclassifiable
  • Measurable disease: subjects must have at least one lesion that is \> 15mm (1.5 cm) in the longest diameter on cross-sectional imaging and measureable in two perpendicular dimensions per computed tomography (spiral CT) or magnetic resonance imaging (MRI)
  • After failure of allogeneic stem cell transplant (ASCT) or after failure of frontline therapy in subjects who declined or are not ASCT candidates
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • White blood cell (WBC) \>= 3000/mm\^3
  • +11 more criteria

You may not qualify if:

  • All primary cutaneous T-cell lymphomas
  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Active, known or suspected autoimmune disease Note: subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment
  • Use of systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications \< 14 days of registration Note: inhaled or topical steroids are permitted; \> 10 mg daily prednisone equivalents are permitted only in adrenal insufficiency in the absence of active autoimmune disease
  • Prohibited treatments and or therapies
  • Autologous stem cell transplant (ASCT) =\< 12 weeks prior to first dose of the study drug
  • Prior treatments (window prior to registration):
  • Chemotherapy =\< 2 weeks
  • Nitrosureas =\< 6 weeks
  • Therapeutic anticancer antibodies =\< 4 weeks
  • Radio- or toxin immunoconjugates =\< 10 weeks
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Bennani NN, Kim HJ, Pederson LD, Atherton PJ, Micallef IN, Thanarajasingam G, Nowakowski GS, Witzig T, Feldman AL, Ansell SM. Nivolumab in patients with relapsed or refractory peripheral T-cell lymphoma: modest activity and cases of hyperprogression. J Immunother Cancer. 2022 Jun;10(6):e004984. doi: 10.1136/jitc-2022-004984.

    PMID: 35750419DERIVED

MeSH Terms

Conditions

Blastic Plasmacytoid Dendritic Cell NeoplasmHTLV-I InfectionsPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyEnteropathy-Associated T-Cell LymphomaMycosis FungoidesLymphoma, Extranodal NK-T-CellLymphoma, T-Cell

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsLeukemiaLymphomaHematologic NeoplasmsNeoplasms by SiteSkin NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDeltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsImmunologic Deficiency SyndromesImmune System DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersLymphoma, Non-HodgkinLymphadenopathyLymphoma, T-Cell, Cutaneous

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Stephen M Ansell MD PhD
Organization
Mayo Clinic
ansell.stephen@mayo.edu
507/284-2511

Study Officials

  • Stephen Ansell

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 9, 2017

Study Start

May 17, 2017

Primary Completion

May 29, 2019

Study Completion

May 29, 2019

Last Updated

April 21, 2020

Results First Posted

April 21, 2020

Record last verified: 2019-05

Locations

US(1)