Nivolumab Consolidation in Older (≥ 65) Patients With Primary CNS Lymphoma

Part of paid clinical trials in Brookline, Massachusetts.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04022980
Phase
PHASE1
Status
Completed

Conditions

  • Brain and Nervous System
  • Eye and Orbit

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    HD-MTX containing induction chemotherapy (per standard of care) followed by Nivolumab consolidation.

Study Details

The primary objective of Stage 1 is to evaluate the safety of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in older subjects with PCNSL in terms of a tolerated dose (based on dose-limiting toxicities) for the expansion phase of the study (Stage 2).The primary objective of Stage 2 is to evaluate the efficacy of nivolumab consolidation after completion of HD-MTX containing induction chemotherapy in terms of the 2-year progression-free survival rate and compare to relevant historical controls

Key Dates

Start date
Mar 31, 2020
Status verified
Dec 2025
Primary completion
Jan 21, 2025
Completion
Dec 22, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1
    Safety Run-In
  • Experimental: Stage 2
    Expansion Cohort

Primary Outcome Measure

Safety of Nivolumab in Older Subjects [ Time Frame: Until up to 6 subjects can be adequately assessed for DLT. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBrooklineMassachusetts02215-
UNC Hospitals, The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Levine Cancer InstituteCharlotteNorth Carolina28204-
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Brookline, MA

By research site
Dana Farber Cancer Institute· Brookline, MAUNC Hospitals, The University of North Carolina at Chapel Hill· Chapel Hill, NCLevine Cancer Institute· Charlotte, NCThe University of Texas - MD Anderson Cancer Center· Houston, TX

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