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MK-1084 for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Solid TumorsMK-1084 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, MK-1084, on patients with solid tumors that have a specific mutation. The trial will also test MK-1084 in combination with another drug, pembrolizumab, on patients with lung cancer who have the same mutation.

Eligible Conditions
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Pembrolizumab
1
BDB018
1
ADG116

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Up to ~50 months

Month 50
Area under the plasma concentration-time curve (AUC) of MK-1084
Maximum plasma concentration (Cmax) of MK-1084
Up to ~21 days
Number of participants who experienced a dose-limiting toxicity (DLT)
Up to ~50 months
Duration of response (DOR)
Number of participants who discontinued study treatment due to an AE
Number of participants who experienced an adverse event (AE)
Objective response rate (ORR)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Pembrolizumab
1
BDB018
1
ADG116

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

2 Treatment Groups

MK-1084
1 of 2
Pembrolizumab plus MK-1084
1 of 2

Experimental Treatment

264 Total Participants · 2 Treatment Groups

Primary Treatment: MK-1084 · No Placebo Group · Phase 1

MK-1084
Drug
Experimental Group · 1 Intervention: MK-1084 · Intervention Types: Drug
Pembrolizumab plus MK-1084Experimental Group · 2 Interventions: MK-1084, Pembrolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~50 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,083 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,681 Previous Clinical Trials
4,957,188 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,638 Previous Clinical Trials
7,941,713 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have measurable disease by RECIST 1.1 criteria.
You are male and you are either abstinent from heterosexual intercourse or you are using contraception.
References

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