EUCTR2018-001461-16-DE
Active, not recruiting
Phase 1
A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies - MK-4280 and Pembrolizumab in Hematologic Malignancies
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites84 target enrollmentAugust 9, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hematologic malignancies
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Enrollment
- 84
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Have measureable disease, defined as at least 1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (CT or MRI). Minimum measurement must be \>15 mm in the longest diameter or \>10 mm in the short axis
- •2\. Be able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy (within 3 months) at Screening
- •PD\-1/L1\-Naive R/R cHL (Cohort 1\)
- •3\. Have histologically confirmed classical Hodgkin lymphoma
- •4\. Have relapse (defined as disease progression after most recent therapy) or refractory (defined as failure to achieve CR or PR to most recent therapy) cHL and meet at least 1 of the following inclusions:
- •a.Have failed to achieve a response or progressed after autologous stem cell transplant.
- •b.Were unable to achieve a CR or PR to salvage chemotherapy and therefore did not proceed to auto\- SCT, or were ineligible for auto\-SCT due to age/co\-morbidities as judged by treating physician.
- •5\. Have not previously been treated with an anti\-PD\-1 or anti\-PD\-L1 therapy
- •PD\-1/L1\-Refractory R/R cHL (Cohort 2 and Cohort 5\)
- •6\. Have histologically confirmed classical Hodgkin lymphoma
Exclusion Criteria
- •1\. Has known clinically active central nervous system involvement
- •2\. A WOCBP who has a positive urine pregnancy test within 72 hours
- •prior to study intervention allocation. If the urine test is positive or
- •cannot be confirmed as negative, a serum pregnancy test will be
- •3\. Has known clinically significant heart disease
- •4\. Has received prior therapy with an anti\-LAG\-3 antibody
- •5\. Cohorts 1, 2, 3, 5: Has received CAR\-T cell therapy
- •6\. Cohort 1: Has received prior therapy with an anti\-PD\-1 or anti\-PD\-L1 antibody
- •7\. Cohorts 2, 3, 4, 5: Has severe hypersensitivity (\=Grade 3\) to pembrolizumab and/or any of its excipients
- •8\. Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study intervention
Outcomes
Primary Outcomes
Not specified
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