Phase 2
N=211
Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)
Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02453594 ↗Enrolled (actual)
211
Serious AEs
21.3%
Results posted
Oct 2024
Primary outcome: Primary: Overall Response Rate (ORR) by BICR Based on IWG Criteria — 78.3; 64.2; 73.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pembrolizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) by BICR Based on IWG Criteria |
78.3; 64.2; 73.3 | — |
| PRIMARY Percentage of Participants Experiencing at Least One Adverse Event (AE) |
98.6; 98.8; 95.0 | — |
| PRIMARY Percentage of Participants Discontinuing Study Drug Due to AEs |
11.6; 6.2; 8.3 | — |
| SECONDARY Overall Response Rate (ORR) by BICR Based on Lugano Criteria |
82.6; 67.9; 68.3 | — |
| SECONDARY Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria |
72.5; 66.7; 71.7 | — |
| SECONDARY Complete Remission Rate (CRR) by BICR Based on IWG Criteria |
24.6; 25.9; 33.3 | — |
| SECONDARY Complete Remission Rate (CRR) by BICR Based on Lugano Criteria |
34.8; 28.4; 35.0 | — |
| SECONDARY Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria |
42.0; 32.1; 43.3 | — |
| SECONDARY Progression-free Survival (PFS) Based on BICR |
16.5; 11.1; 19.7 | — |
| SECONDARY Progression-free Survival (PFS) Assessed by the Investigator |
24.9; 13.9; 22.0 | — |
| SECONDARY Duration of Response (DOR) Based on BICR |
25.0; 11.1; 24.4 | — |
| SECONDARY Duration of Response (DOR) Assessed by the Investigator |
25.0; 16.4; 24.7 | — |
| SECONDARY Overall Survival (OS) |
NA; NA; NA | — |
Summary
This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT.
The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.
Eligibility Criteria
Inclusion criteria
- Relapsed or refractory de novo classical Hodgkin lymphoma
- Participant may have failed to achieve a response to, progressed after, or be ineligible for autologous stem cell transplant (auto-SCT)
- Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease
- Adequate organ function
Exclusion criteria
- Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- Prior monoclonal antibody within 4 weeks prior to study Day 1 or chemotherapy, targeted small molecular therapy, or radiation therapy within 2 weeks prior to study Day 1
- Prior allogeneic hematopoietic stem cell transplantation
- Known clinically active central nervous system involvement
- Known additional malignancy that is progressing or requires active treatment
- Has a known history of Human Immunodeficiency Virus (HIV)
- Has known active Hepatitis B (HBV) or Hepatitis C (HCV)
- Active autoimmune disease requiring systemic treatment in past 2 years
- Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Data sourced from ClinicalTrials.gov (NCT02453594). 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.