Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT03495713
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 3 mg/kg will be administered on day 1 (pre-response assessment week 0) and on day 1 and continued per standard of care and institutional practices. A

Study Details

This is a Phase II single-arm, single-site, open label clinical trial with r/r HL patients, aimed to determine whether a RadVax approach using low-dose RT added to nivolumab can improve response among patients who do not achieve a CR to nivolumab alone. The long-term goal is to develop an effective regimen for r/r HL patients.

Key Dates

Start date
Nov 2, 2018
Status verified
Dec 2023
Primary completion
Apr 20, 2022
Completion
Apr 20, 2022

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Subjects will receive initial treatment with the immunomodulatory agent, nivolumab, followed by low-dose (4 Gy x 2) involved-site radiotherapy in subjects with less than an anatomic CR after the first restaging scan. Patients with anatomic CR will continue nivolumab alone without radiotherapy. Eligible patients will have r/r disease with at least 2 sites of measurable disease, and must be eligible for treatment with nivolumab.

Primary Outcome Measure

Complete Response Rate [ Time Frame: 25 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19035-

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By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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