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Taxane

Pembrolizumab for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Athenex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of MTD
Tumor response rate
Secondary outcome measures
Disease Control Rate (DCR)
Duration of response (DOR)
Incidence of Adverse Events
+4 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Dose expansion-NSCLC cancerExperimental Treatment2 Interventions
The dose expansion period will enroll subjects with NSCLC to further evaluate the activity and safety of the study treatment. Oraxol will be administered at the dose determined from part 1 for 2 out of 3 weeks. Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group II: Dose expansion-Gastric/GEExperimental Treatment2 Interventions
The dose expansion period will enroll subjects with gastric/gastro-esophageal cancer to further evaluate the activity and safety of the study treatment. Oraxol will be administered at the dose determined from part 1 for 2 out of 3 weeks. Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group III: Dose escalation-Arm 6Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 5 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group IV: Dose escalation-Arm 5Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 5 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group V: Dose escalation-Arm 4Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 5 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group VI: Dose escalation-Arm 3Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 4 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group VII: Dose escalation-Arm 2Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 3 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group VIII: Dose escalation-Arm 1Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 2 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Oraxol
2018
Completed Phase 3
~620

Find a Location

Who is running the clinical trial?

Athenex, Inc.Lead Sponsor
26 Previous Clinical Trials
1,934 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,066,002 Total Patients Enrolled
David Cutler, MDStudy DirectorSr. Vice President of Clinical Development
10 Previous Clinical Trials
641 Total Patients Enrolled
~5 spots leftby Jun 2025
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