Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatment pembrolizumab
Phase phase 2
Target PD-1
Sponsor Merck Sharp & Dohme Corp.
Start date June 2015
End date June 2016
Trial size 210 participants
Trial identifier NCT02453594, 153005, 2014-004482-24, 3475-087

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for up to 24 months.
pembrolizumab MK-3475
IV infusion
(Experimental)
Participants with RRcHL who were unable to achieve CR or PR to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months.
pembrolizumab MK-3475
IV infusion
(Experimental)
Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
pembrolizumab MK-3475
IV infusion

Primary Outcomes

Measure
Overall Response Rate (ORR)
time frame: Up to 35 months
Percentage of Participants Experiencing at Least One Adverse Event (AE)
time frame: Up to 27 months
Percentage of Participants Discontinuing Study Drug Due to AEs
time frame: Up to 24 months

Secondary Outcomes

Measure
Complete Remission Rate (CRR)
time frame: Up to 35 months
Progression-free Survival (PFS)
time frame: Up to 35 months
Duration of Response (DOR)
time frame: Up to 35 months
Overall Survival (OS)
time frame: Up to 35 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects With Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..