A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL)… (NCT04875195) | Clinical Trial Compass
CompletedPhase 2
A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)
United States, Brazil66 participantsStarted 2021-06-07
Plain-language summary
The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have a histologically confirmed diagnosis of cHL or PMBCL, according to the World Health Organization (WHO) classification \[Swerdlow, S. H., et al 2008\].
* Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is \>15 mm in long axis, regardless of the length of the short axis, and/or extranodal lesion of \>10 mm in long and short axis.
PMBCL-Specific Disease Characteristics:
* Have relapsed or refractory PMBCL and:
* Have relapsed after auto-stem cell transplant (SCT) or have failed to achieve a CR or PR within 60 days of auto-SCT. Participants may have received intervening therapy after auto-SCT for relapsed or refractory disease, in which case they must have relapsed after or be refractory to their last treatment.
OR
\- For participants who are ineligible for auto-SCT, have received at least ≥2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. At least 1 of the prior lines of therapy must contain a rituximab-based regimen.
Note: Participants should not need urgent cytoreductive therapy.
* Relapsed Disease: disease progression after achieving an overall response of PR or CR in response to the most recent therapy
* Refractory Disease: failure to achieve CR or PR to the most recent therapy.
cHL-Specific Disease Characteristics:
* Have relapsed or refractory cHL and:
* Have relapsed during the…
What they're measuring
1
Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator