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NCT03249792 · ClinicalTrials.gov registry record · Phase 1
Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT03249792 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 140 participants.
The verdict
NCT03249792, a Phase 1 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a maximum administered dose (MAD) of MK-2118 when administered via intratumoral (IT) injection as monotherapy and in combination with pembrolizumab (MK-3475) intravenous (IV) infusion, or via subcutaneous (SC) injection in combination with pembrolizumab IV infusion in the treatment of adult participants with advanced/metastatic solid tumors or lymphomas. Participants will receive either MK-2118 monotherapy or MK-2118 in combination with pembrolizumab for up to 35 cycles for Arms 1-3 or up to 36 cycles for Arm 4 (up to approximately 2 years). All participants will undergo at least a 24-hour observation period following the first three administrations of MK-2118 (Arms 1-3: Cycle 1 Days 1, 8, and 15. Arm 4: Cycle 1 Days 1 and 8; and Cycle 2 Day 1). Qualified participants who experience radiographic or clinical progression in Arm 1 (MK-2118 Intra-tumoral \[IT\] monotherapy) may switch over to Arm 2 (MK-2118 IT + Pembrolizumab IV Combination Therapy) at an eligible dose. Pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms, per protocol.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG MK-2118 (IT)
- DRUG MK-2118 (SC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03249792
The ClinicalTrials.gov registry entry for NCT03249792 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03249792 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03249792 about?
NCT03249792 is a clinical study titled "Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)". The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a maximum administered dose (MAD) of MK-2118 when administered via intratumoral (IT) injection as monotherapy and in combin...
What is the current status of trial NCT03249792?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2017-09-20. Estimated completion is 2023-02-22.
What interventions are being tested in trial NCT03249792?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-2118 (IT) (DRUG), MK-2118 (SC) (DRUG).
Who is sponsoring clinical trial NCT03249792?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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