Pembrolizumab for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid TumorsPembrolizumab - Biological
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and effectiveness of a new cancer drug.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 24 months

24 months
Disease Control Rate (DCR)
Duration of response (DOR)
Incidence of Adverse Events
Overall survival (OS)
Progression free survival (PFS)
Time to response
Tumor response rate
duration of response (DOS)
3 weeks
Determination of MTD
Day 2
Pharmacokinetics of Oraxol

Trial Safety

Safety Progress

1 of 3

Trial Design

9 Treatment Groups

Dose expansion-Urothelial cancer
1 of 9
Dose escalation-Arm 4
1 of 9
Dose expansion-NSCLC cancer
1 of 9
Dose escalation-Arm 5
1 of 9
Dose escalation-Arm 6
1 of 9
Dose expansion-Gastric/GE
1 of 9
Dose escalation-Arm 3
1 of 9
Dose escalation-Arm 1
1 of 9
Dose escalation-Arm 2
1 of 9

Experimental Treatment

86 Total Participants · 9 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1

Dose expansion-Urothelial cancerExperimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose escalation-Arm 4Experimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose expansion-NSCLC cancerExperimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose escalation-Arm 5Experimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose escalation-Arm 6Experimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose expansion-Gastric/GEExperimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose escalation-Arm 3Experimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose escalation-Arm 1Experimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Dose escalation-Arm 2Experimental Group · 2 Interventions: Pembrolizumab, Oraxol · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
HM-30181
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,681 Previous Clinical Trials
4,957,366 Total Patients Enrolled
Athenex, Inc.Lead Sponsor
25 Previous Clinical Trials
1,945 Total Patients Enrolled
David Cutler, MDStudy DirectorSr. Vice President of Clinical Development
10 Previous Clinical Trials
683 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have metastatic or unresectable solid tumors for which pembrolizumab is an FDA-approved therapy.
You have an actionable mutation or alteration.
Subjects must have progressed on previous anti-PD-1 therapy as single agent or combination therapy.
You have at least one measurable site of disease as defined as per RECIST v1.1 criteria.