Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04938232
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is looking at the effects of Ipilimumab when it is given alone or in combination with Nivolumab to patients with relapsed or refractory classic Hodgkin's lymphoma (cHL). The names of the study drugs involved in this study are: * Ipilimumab * Nivolumab

Key Dates

Start date
Jun 4, 2021
Status verified
Jan 2026
Primary completion
Apr 1, 2024
Completion
Aug 1, 2026

Study Design

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

Arms

  • Experimental: Disease Progression after previous therapy
    Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable. * Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles * Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles * Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Chicago MedicineChicagoIllinois60637-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-

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