Phase 2
Completed N=146
Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)
Source: ClinicalTrials.gov NCT05008224 ↗Enrolled (actual)
146
Serious AEs
19.4%
Results posted
Oct 2024
Primary outcomePrimary: Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria — 67.0 Percentage of Participants
Summary
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria |
67.0 | — |
| SECONDARY CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria |
71.9 | — |
| SECONDARY Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria |
NA | — |
| SECONDARY Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy (PET Scan 2) |
19.9 | — |
| SECONDARY Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and AVD Chemotherapy (PET Scan 3) |
70.5 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) |
135; 132; 17 | — |
| SECONDARY Number of Participants Who Discontinued Study Treatment Due to an AE |
15; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
The main inclusion criteria include, but are not limited to the following:
- Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
- Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
- Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention
Exclusion Criteria
The main exclusion criteria include, but are not limited to the following:
- Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
- Has an uncontrolled intercurrent cardiovascular illness
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history or current evidence of pulmonary fibrosis
- Has had an allogenic tissue/solid organ transplant
Data sourced from ClinicalTrials.gov (NCT05008224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.