Clinical trial · Interventional
Study of MK-1248 With and Without Pembrolizumab (MK-3475) for Participants With Advanced Solid Tumors (MK-1248-001)
A Phase 1 Trial of MK-1248 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment prematurely discontinued due to program prioritization \& not due to any safety concerns.
Summary
Brief summary (as posted)
In this study, participants with advanced solid tumors were assigned to receive escalating doses of either MK-1248 alone or MK-1248 in combination with pembrolizumab (MK-3475). This study used the number of dose-limiting toxicities (DLTs) at each dose level to find and confirm the maximum tolerated dose (or maximum administered dose) for MK-1248 alone and in combination with pembrolizumab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK-1248 | Biological | — | UNRESOLVED |
| pembrolizumab | Biological | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MK-1248
- description
- Participants received escalating doses of MK-1248 at assigned dose (dose range: 0.12 mg to 170 mg MK-1248) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to \~3 months).
- interventionNames
- Biological: MK-1248
- type
- EXPERIMENTAL
- label
- MK-1248 + Pembrolizumab
- description
- Participants received escalating doses of MK-1248 at assigned dose (dose range: 0.12 mg to 60 mg MK-1248) via IV infusion on Day 1 of each 21-day cycle for a maximum of 4 cycles (up to \~3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months).
- interventionNames
- Biological: MK-1248
- Biological: pembrolizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy that may convey clinical benefit * Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria * Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale * Adequate organ function * Female participants of childbearing potential should be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication * Male participants should agree to use adequate contraception starting with the first dose of study therapy through 180 days after the last dose of study medication * Can submit a baseline tumor sample Exclusion Criteria: * Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study medication, or not recovered from adverse events due to cancer therapeutics administered more than 4 weeks earlier * Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication * Previous treatment with another agent targeting the glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR) receptor * Previous treatment with an immunomodulatory therapy and was discontinued from that therapy due to an immune-related adverse event * Expected to require any other form of antineoplastic therapy while on study * On chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication * History of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years with the exception of successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Severe hypersensitivity reaction to treatment with another monoclonal antibody * Active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo or resolved childhood asthma/atopy, or endocrine deficiency following treatment with an immunomodulatory agent * Active infection requiring therapy * Active or a history of non-infectious pneumonitis * Prior stem cell or bone marrow transplant * Known history of human immunodeficiency virus (HIV), active chronic or acute hepatitis B or C * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study * Regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol), at the time of signing informed consent * Symptomatic ascites or pleural effusion * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study through 180 days after the last dose of study medication * Major surgery within 16 weeks prior to screening * Live vaccine within 30 days prior to first dose of study medication
References
Publications (1)
- DERIVEDGeva R, Voskoboynik M, Dobrenkov K, Mayawala K, Gwo J, Wnek R, Chartash E, Long GV. First-in-human phase 1 study of MK-1248, an anti-glucocorticoid-induced tumor necrosis factor receptor agonist monoclonal antibody, as monotherapy or with pembrolizumab in patients with advanced solid tumors. Cancer. 2020 Nov 15;126(22):4926-4935. doi: 10.1002/cncr.33133. Epub 2020 Aug 18. PMID 32809217