Trials / Completed
CompletedNCT01953692
A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)
A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to evaluate the safety, tolerability, and efficacy of pembrolizumab (MK-3475, KEYTRUDA®) and pembrolizumab in combination with lenalidomide (Cohort 5 only) in hematologic malignancies. The primary study hypotheses are that treatment with pembrolizumab will result in a clinically meaningful improvement in Objective Response Rate (ORR) or Complete Remission Rate (CRR). The study includes an initial dose determination to establish the recommended phase 2 dose (RP2D) of lenalidomide given in combination with pembrolizumab in Cohort 5. With Protocol Amendment 08, enrollment in the Multiple Myeloma arm (Cohort 2) has been completed and no further enrollment will be allowed and enrollment in the Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma arm (Cohort 5) has been discontinued and no further enrollment will be allowed.
Conditions
- Myelodysplastic Syndrome
- Multiple Myeloma
- Hodgkin Lymphoma
- Non-Hodgkin Lymphoma
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Primary Mediastinal B-Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | IV infusion |
| DRUG | Lenalidomide 20 mg | oral capsule |
| DRUG | Lenalidomide 25 mg | oral capsule |
Timeline
- Start date
- 2013-11-22
- Primary completion
- 2020-06-26
- Completion
- 2020-06-26
- First posted
- 2013-10-01
- Last updated
- 2021-08-04
- Results posted
- 2021-07-12
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01953692. Inclusion in this directory is not an endorsement.