Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL (NCT04938232) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL
United States13 participantsStarted 2021-06-04
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically determined classic Hodgkin lymphoma with pathologic review at the participating institution.
* Participants must have measurable disease, defined as a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT, or MR. Imaging must have been completed no greater than 6 weeks prior to study enrollment. Measurable disease that has previously been irradiated is permissible only if there has been evidence of progression since the radiation.
* Patients must have progressed after two or more lines of systemic treatment, including autologous stem cell transplantation, if eligible.
* Progression of disease or relapse following treatment with nivolumab or pembrolizumab. Intervening treatments with between PD-1 mAb therapy and the trial are permitted.
* Patients may have had a prior autologous stem cell transplant and may have been treated with chimeric antigen receptor T-cells (CAR T-cells).
* Age ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (see Appendix A)
* Adequate hematologic and organ function as defined below:
* Absolute neutrophil count \> 1.0x109/L unless due to marrow involvement by lymphoma in which case ANC must be \>0.75x109/L. Growth factor support is allowed provided it is received at least 5 days prior to enrollment labs.
* Platelets \> 75 x109/L, unless due to marrow involvement by lymphoma, in which case platelets must be \>50 x109/L
* Estimated GFR (by Cockr…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment